114 results on '"Gil-Gouveia R"'
Search Results
2. Dynamic functional connectivity in migraine during the interictal phase: a resting-state fMRI study
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Esteves, I., Fonseca, C., Xavier, M., Fouto, A., Ruiz-Tagle, A., Caetano, G., Nunes, R., Gil-Gouveia, R., Cabral, J., Martins, I. Pavão, Rosa, A, Figueiredo, P., and Veritati - Repositório Institucional da Universidade Católica Portuguesa
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Question: Migraine is a cyclic and complex disorder, characterized by attacks of headache, sensory and cognitive disturbances1. Thalamocortical connectivity in migraine has been found to be transiently abnormal2. Our aim was to assess if the dynamical properties of the migraine brain are affected during the interictal phase. Methods: Resting-state functional MRI data was collected from 14 menstrual migraine patients without aura (interictal phase) and 12 healthy controls (menstrual post-ovulation phase). fMRI data processing included3: motion and distortion correction, temporal highpass filter, regression of motion and physiological confounds, spatial smoothing, and parcellation with the Desikan atlas. Dynamic functional connectivity (dFC) between regions was computed using phase coherence, and recurrent dFC states were identified by kmeans clustering (k ranging between 3 and 15) of the leading eigenvectors of dFC in each time point4. Permutation tests were performed to evaluate statistically significant differences between patients and controls in the probability of occurrence and the mean lifetime of the dFC states. Results: Similar dFC states were found consistently across different numbers of clusters, k, which resembled the canonical resting-state networks as expected. Compared to healthy controls, migraine patients show a significantly lower mean lifetime in one dFC state, when grouping in 4, 5 and 6 clusters. No differences were found for the probability of occurrence. Conclusions: Migraine may be linked to a disruption of brain networks dynamics. This emphasizes the need to adopt time-resolved methods, in addition to static, to study functional connectivity, to better understand the mechanisms of migraine. Our next step will be to assess the dynamics of the migraine brain throughout the migraine cycle.
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- 2022
3. Do novel European Headache Federation criteria identify differences in migraine burden?: baseline data of an international real-life study on resistant and refractory migraine (REFINE)
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Caponnetto, V., Ornello, R., Rosignoli, C., De Santis, N., Bayar, D., Braschinsky, M., Carnovali, M., Gentile, M., Gil-Gouveia, R., Iaccarino, G., Leheste, A. R., Martelletti, P., Mazzanti, C., Munoz-Vendrell, A., Oliveira, R., Ozge, A., Martins, I. Pavao, Pozo-Rosich, P., Prudenzano, M. P., Ryliškienė, Kristina, Sanchez del Rio, M., Vainauskienė, J., Vernieri, F., Katsarava, Z., Sacco, S., and Veritati - Repositório Institucional da Universidade Católica Portuguesa
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Question. We evaluated if EHF criteria for resistant (RES) and refractory (REF) migraine identify patients with more severe migraine burden. Methods. We performed an observational, multi center, international study to compare baseline characteristics, comorbidities, and PROMs of non-resistant and non-refractory (NRNR) migraine, RES and REF individuals in the REFINE study. Results. We included 175 individuals with NRNR migraine, 133 (39.7%) with RES and 27 (8.0%) with REF. Individuals with RES and REF migraine as compared to those with NRNR reported higher monthly migraine days (median=8, IQR=5-14 vs. median=13, IQR=10- 17 and median=15, IQR=10-20; p≤0.001), months of chronification (median=24, IQR=12-72 vs. median=40, IQR=12-108 and median=60, IQR=18-96; p=0.044), monthly days of symptomatic drugs assumption (median=8, IQR=5-15 vs. median=12, IQR=9-20 and median=15, IQR=10-20; p≤0.001), medication overuse (19.4% vs. 45.9% and 40.7%; p≤0.001). They also had more comorbidities such as depression (18.3% vs. 31.1% and 44.4%; p=0.002) and anxiety (13.7% vs. 21.1% and 37%; p=0.009). In these groups, PROMs also revealed a higher presence of anxiety (p≤0.001) and depression (p≤0.001) symptoms and poorer sleep quality (p=0.006). Regarding specific perceptions about migraine, RES and REF individuals reported higher impact of migraine on daily life (p≤0.001) and work, household work, and social life (p≤0.001), along with a lower perception of the effectiveness of their ongoing treatment for migraine (p≤0.001), when compared to NRNR subjects (Table 1). Conclusion. RES and REF migraine is associated with relevant migraine burden considering migraine features, comorbidities and scores at several scales; the severe burdensome condition of RES and REF is confirmed by the median number of monthly migraine days and PROMs.
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- 2022
4. Cognition in menstrually related migraine: neural correlates of working memory along the cycle
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Ruiz-Tagle, A., Fouto, A., Caetano, G., Domingos, C., Esteves, I., Gil-Gouveia, R., Nunes, R., Martins, I. Pavão, Figueiredo, P., and Veritati - Repositório Institucional da Universidade Católica Portuguesa
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QUESTION: Hormones play a preponderant role in triggering migraine attacks, with women having higher prevalence and severity of migraine due to their influence along the reproductive cycle1. The preictal, ictal and postictal phases tend to include cognitive executive difficulties along with the rest of the attack symptoms2. Fluctuations in neural sensitivity observed in migraine could underlie such difficulties3. On the other hand, functional and structural changes in brain structures related to cognitive processes along the menstrual cycle have also been documented4. We aim to use functional Magnetic Resonance Imaging (fMRI) to evaluate working memory at different stages of the migraine cycle and compare to a non-migraine population while controlling for their menstrual phases. METHODS: A clinical sample of 15 women suffering from episodic migraine with menstrual-related attacks were recruited. They underwent fMRI sessions with a verbal N-back task in different phases of the migraine cycle, namely, preictal, ictal, postictal and interictal phase. 15 nonmigraine controls matched for gender and age were assessed during premenstrual and post ovulation phase. A neuropsychological battery and questionnaires quantifying clinical symptoms and attack description at the time of the exam were also applied. RESULTS: We report results for 70 sessions of acquisition in whole brain group analysis using a cluster threshold of z > 2.3. We observed left orbital prefrontal areas with significantly higher activation during preictal (z =3.44), ictal (z=3.49) and interictal (z=3.3) phases compared to postictal phase. CONCLUSIONS: The brain activation observed in prefrontal regions during the migraine attack phases could be related to cognitive inhibition while performing a working memory task.
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- 2022
5. White-matter microstructural changes in episodic menstrual migraine compared with hormonal controls
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Fouto, A., Nunes, R., Ruiz-Tagle, A., Esteves, I., Caetano, G., Silva, N. A., Vilela, P., Gil-Gouveia, R., Figueiredo, P., and Veritati - Repositório Institucional da Universidade Católica Portuguesa
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Question: Do patients with episodic menstrual migraine exhibit white-matter microstructural changes? Methods: 14 women with episodic menstrual migraine (35±8yrs) were assessed during interictal phase together with 11 healthy women (29±10yrs) during a matching phase of their menstrual cycle (post-ovulation). 2D-EPI multi-shell DWI data were acquired on a 3T Siemens Vida (64-ch coil) and preprocessed using DESIGNER [1]. Diffusion tensor / kurtosis imaging (DTI/DKI) parameter maps were estimated and skeletonised [2] and histogram-metrics were computed for each subject: median, peak height, width, and value. Results: Voxelwise statistical analysis [3] revealed multiple whitematter regions with lower MD and AD in patients, with no differences in FA and RD. Interestingly, migraineurs showed increased MK, AK and RK. Moreover, significant groups differences (Mann- Whitney test with Bonferroni correction) were found in histogram-metrics MD peak value, AD median and peak height and AK median. Median AK was positively associated (Spearman correlation) with disease duration but not with attack frequency and pain intensity. Conclusion: Our findings extended previous reports of whitematter microstructural changes in migraineurs across multiple brain regions [4, 5]. DKI histogram-metrics showed potential as disease biomarkers.
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- 2022
6. Burden and attitude to resistant and refractory migraine: a survey from the European Headache Federation with the endorsement of the European MigraineHeadache Alliance
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Sacco S., Lampl C., Maassen van den Brink A., Caponnetto V., Braschinsky M., Ducros A., Little P., Pozo-Rosich P., Reuter U., Ruiz de la Torre E., Sanchez Del Rio M., Sinclair A. J., Martelletti P., Katsarava Z., Cakciri G., Djamandi P., Grabova S., Halili G., Kruja J., Kuqo A., Naco D., Quka A., Stefanidhi L., Vyshka G., Zekja I., Bruera O., Gomez D., Guitian B., Roma J. C., Chen I. L., Bashirova S., Linkov M., Van Den Abbeele D., Vanderschueren G., Araujo R., Arruda R., Catharino A., Ciriaco J., Dalla Corte A., Dornas R., Felsenfeld B., Fonseca Taufner A., Fragoso Y., Hurtado R., Isoni Martins D., Londero R., Melo L., Mignoni K. S., Sgobbi De Souza P. V., Souza M. N., Osman S., Baltzer V., Pacheco Mosquera L. F., Dubroja I., Hucika Z., Lisak M., Lovrencic-Huzjan A., Lusic I., Mahovic Lakusic D., Mikulenka P., Rehulka P., Amin F. M., Antic S., Fakhril-Din Z., Moeller-Hansen J., Munksgaard S., Nan A. M., Pellesi L., Schytz H., Vides M., Braschinsky K., Krikmann U., Roos C., Cauchie A., Christian L., Guegan-Massardier E., Demarquay G., Gilles G., Mawet J., Kuhn E., Lanteri Minet M., Bustuchina Vlaicu M., Moisset X., Muresan M., Najjar-Ravan M., Giraud P., Simonin S., De Gaalon S., Chakhava G., Demuria M., Gegelashvili G., Kapanadze N., Antonakakis A., Gaul C., Forderreuther S., Huhn J. -I., Ibragimov S., Kamm K., Raffaelli B., Czaniera R., Ruscheweyh R., Gavanozi E., Karagiorgis G., Mavridism T., Ertsey C., Shubham D., Callista Tanowi A. D., Erdana Putra S., Hadi D. W., Kurnia L., Nasrul M., Albanese M., Antonaci F., Asioli G. M., Baschi R., Bentivegna E., Brunelli N., Caratozzolo S., Catarci T., Cherchi A., Corbelli I., Costa A., De Luca C., Doretti A., Favoni V., Ghiotto N., Giamberardino M. A., Giani L., Zanchin G., Govone F., Grillo G., Mampreso E., Negro A., Ornello R., Pasculli M., Pensato U., Prudenzano M. P. A., Quintana S., Rapisarda R., Romoli M., Russo A., Russo M., Spuntarelli V., Tiseo C., Torrente A., Vacca A., Vaula G., Vigano A., Vigneri S., Freimane A., Slosberga E., Zvaune L., Tan H. J., Fenech C., Cobilt-Catana R., De La Garza Neme Y., Martinez M., Proano Narvaez J. V., Rodriguez Herrera A., Vazquez D., Grosu O., Jakupi A., Kristoffersen E. S., Tronvik E., Winsvold B. S., Azhar M., Reyes Alvarez M. T., Vilchez Fernandez L., Dayrit G. D., Czapinska-Ciepiela E. K., Fila M., Gryglas-Dworak A., Couto M., Esperanca P., Ferreira A., Gil-Gouveia R., Goncalves A., Lopes M., Lourenco M., Machado J., Marinho M., Miranda M. A., Palavra F., Parreira E., Pavao Martins I., Pereira L., Pereira Monteiro J. M., Leahu P., Aloman S., Abramova E., Akhmadeeva L., Belopasova A., Bogdanova I., Chernyak M., Epifanova M., Fedorova E., Felbush A., Karpova M., Korobkova D., Korotkova D., Latysheva N., Makeeva T., Mikhalkina K., Osipova V., Roshchina O., Serga A., Serousova O. V., Sidorova Y., Skiba I., Skorobogatykh K., Vashchenko N., Apostolski S., Buder N., Kopitovic A., Mirjana J., Podgorac A., Rakic D., Simic S., Zarko M., Trajkovic J. Z., Beltran-Blasco I., Calabria Gallego M. D., Diaz Insa S., Ezpeleta D., Fernandez M., Garcia-Azorin D., Gonzalez-Garcia N., Guerrero A. L., Guillamon E., Herreros Rodriguez J., Layos-Romero A., Medrano V., Minguez-Olaondo A., Navarro Munoz S., Pare Curell M., Ruibal M., Sanchez Alvarez J. M., Santos S., Soler R., Viguera J., Zabalza R., Abdelrahman T., Abobaker Hamza S. B., Mustafa M. N., Edvinsson L., Gantenbein A., Maraffi I., Couturier E., Dirkx T., Hoebert M., Van Oosterhout W., Wim M., Zwartbol R., Bakir M., Demirel H., Erdemoglu A. K., Ertem D. H., Gonullu S., Ilgaz Aydinlar E., Inan L. E., Olmez B., Ozbenli T., Ozge A., Uluduz D., Uyar Cankay T., Yalinay Dikmen P., Saxena A. B., Bozhenko M., Bozhenko N., Bubnov R., Tsurkalenko O., Abu-Arafeh I., Idrovo L., Miller S., Nirmalananthan N., Sinclair A., Taleti E., Valori A., Whitehouse W., Zermansky A., Thura M., Institut Català de la Salut, [Sacco S, Caponnetto V] Neuroscience section – Department of Biotechnological and Applied Clinical Sciences and (Edificio Coppito 2), University of L’Aquila, Via Vetoio, 67100 L’Aquila, Italy. Regional Referral Headache Center of the Abruzzo Region, ASL Avezzano-Sulmona-L’Aquila, L’Aquila, Italy. [Lampl C] Department of Neurology, Headache Medical Centre Linz, Hospital Barmherzige Brüder, Centre of Integrative Medicine (ZiAM) Ordensklinikum Linz, Linz, Austria. [Maassen van den Brink A] Division of Pharmacology, Department of Internal Medicine, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands. [Braschinsky M] Headache Clinic, Department of Neurology, Tartu University Clinics, Tartu, Estonia. [Ducros A] Headache Unit, Neurology Department, Montpellier University Hospital and Montpellier University, Montpellier, France. [Pozo-Rosich P] Unitat de Cefalea, Servei de Neurologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Grup d'Investigació en Cefalees i Dolors Neurològics, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus, Sacco, S., Lampl, C., Maassen van den Brink, A., Caponnetto, V., Braschinsky, M., Ducros, A., Little, P., Pozo-Rosich, P., Reuter, U., Ruiz de la Torre, E., Sanchez Del Rio, M., Sinclair, A. J., Martelletti, P., Katsarava, Z., Cakciri, G., Djamandi, P., Grabova, S., Halili, G., Kruja, J., Kuqo, A., Naco, D., Quka, A., Stefanidhi, L., Vyshka, G., Zekja, I., Bruera, O., Gomez, D., Guitian, B., Roma, J. C., Chen, I. L., Bashirova, S., Linkov, M., Van Den Abbeele, D., Vanderschueren, G., Araujo, R., Arruda, R., Catharino, A., Ciriaco, J., Dalla Corte, A., Dornas, R., Felsenfeld, B., Fonseca Taufner, A., Fragoso, Y., Hurtado, R., Isoni Martins, D., Londero, R., Melo, L., Mignoni, K. S., Sgobbi De Souza, P. V., Souza, M. N., Osman, S., Baltzer, V., Pacheco Mosquera, L. F., Dubroja, I., Hucika, Z., Lisak, M., Lovrencic-Huzjan, A., Lusic, I., Mahovic Lakusic, D., Mikulenka, P., Rehulka, P., Amin, F. M., Antic, S., Fakhril-Din, Z., Moeller-Hansen, J., Munksgaard, S., Nan, A. M., Pellesi, L., Schytz, H., Vides, M., Braschinsky, K., Krikmann, U., Roos, C., Cauchie, A., Christian, L., Guegan-Massardier, E., Demarquay, G., Gilles, G., Mawet, J., Kuhn, E., Lanteri Minet, M., Bustuchina Vlaicu, M., Moisset, X., Muresan, M., Najjar-Ravan, M., Giraud, P., Simonin, S., De Gaalon, S., Chakhava, G., Demuria, M., Gegelashvili, G., Kapanadze, N., Antonakakis, A., Gaul, C., Forderreuther, S., Huhn, J. -I., Ibragimov, S., Kamm, K., Raffaelli, B., Czaniera, R., Ruscheweyh, R., Gavanozi, E., Karagiorgis, G., Mavridism, T., Ertsey, C., Shubham, D., Callista Tanowi, A. D., Erdana Putra, S., Hadi, D. W., Kurnia, L., Nasrul, M., Albanese, M., Antonaci, F., Asioli, G. M., Baschi, R., Bentivegna, E., Brunelli, N., Caratozzolo, S., Catarci, T., Cherchi, A., Corbelli, I., Costa, A., De Luca, C., Doretti, A., Favoni, V., Ghiotto, N., Giamberardino, M. A., Giani, L., Zanchin, G., Govone, F., Grillo, G., Mampreso, E., Negro, A., Ornello, R., Pasculli, M., Pensato, U., Prudenzano, M. P. A., Quintana, S., Rapisarda, R., Romoli, M., Russo, A., Russo, M., Spuntarelli, V., Tiseo, C., Torrente, A., Vacca, A., Vaula, G., Vigano, A., Vigneri, S., Freimane, A., Slosberga, E., Zvaune, L., Tan, H. J., Fenech, C., Cobilt-Catana, R., De La Garza Neme, Y., Martinez, M., Proano Narvaez, J. V., Rodriguez Herrera, A., Vazquez, D., Grosu, O., Jakupi, A., Kristoffersen, E. S., Tronvik, E., Winsvold, B. S., Azhar, M., Reyes Alvarez, M. T., Vilchez Fernandez, L., Dayrit, G. D., Czapinska-Ciepiela, E. K., Fila, M., Gryglas-Dworak, A., Couto, M., Esperanca, P., Ferreira, A., Gil-Gouveia, R., Goncalves, A., Lopes, M., Lourenco, M., Machado, J., Marinho, M., Miranda, M. A., Palavra, F., Parreira, E., Pavao Martins, I., Pereira, L., Pereira Monteiro, J. M., Leahu, P., Aloman, S., Abramova, E., Akhmadeeva, L., Belopasova, A., Bogdanova, I., Chernyak, M., Epifanova, M., Fedorova, E., Felbush, A., Karpova, M., Korobkova, D., Korotkova, D., Latysheva, N., Makeeva, T., Mikhalkina, K., Osipova, V., Roshchina, O., Serga, A., Serousova, O. V., Sidorova, Y., Skiba, I., Skorobogatykh, K., Vashchenko, N., Apostolski, S., Buder, N., Kopitovic, A., Mirjana, J., Podgorac, A., Rakic, D., Simic, S., Zarko, M., Trajkovic, J. Z., Beltran-Blasco, I., Calabria Gallego, M. D., Diaz Insa, S., Ezpeleta, D., Fernandez, M., Garcia-Azorin, D., Gonzalez-Garcia, N., Guerrero, A. L., Guillamon, E., Herreros Rodriguez, J., Layos-Romero, A., Medrano, V., Minguez-Olaondo, A., Navarro Munoz, S., Pare Curell, M., Ruibal, M., Sanchez Alvarez, J. M., Santos, S., Soler, R., Viguera, J., Zabalza, R., Abdelrahman, T., Abobaker Hamza, S. B., Mustafa, M. N., Edvinsson, L., Gantenbein, A., Maraffi, I., Couturier, E., Dirkx, T., Hoebert, M., Van Oosterhout, W., Wim, M., Zwartbol, R., Bakir, M., Demirel, H., Erdemoglu, A. K., Ertem, D. H., Gonullu, S., Ilgaz Aydinlar, E., Inan, L. E., Olmez, B., Ozbenli, T., Ozge, A., Uluduz, D., Uyar Cankay, T., Yalinay Dikmen, P., Saxena, A. B., Bozhenko, M., Bozhenko, N., Bubnov, R., Tsurkalenko, O., Abu-Arafeh, I., Idrovo, L., Miller, S., Nirmalananthan, N., Sinclair, A., Taleti, E., Valori, A., Whitehouse, W., Zermansky, A., Thura, M., and Internal Medicine
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Investigative Techniques::Epidemiologic Methods::Data Collection::Surveys and Questionnaires [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,medicine.medical_specialty ,Pediatrics ,Neurology ,Consensus ,enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::trastornos con cefaleas::cefaleas primarias::trastornos migrañosos [ENFERMEDADES] ,migraine ,migraine care ,refractory migraine ,resistant migraine ,consensus ,cross-sectional studies ,headache ,humans ,surveys and questionnaires ,migraine disorders ,Pain medicine ,Moderate confidence ,Migraine Disorders ,Medizin ,Consensu ,Migranya - Tractament ,Qüestionaris ,Refractory ,Surveys and Questionnaires ,medicine ,Surveys and Questionnaire ,Humans ,Clinical significance ,Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Headache Disorders::Headache Disorders, Primary::Migraine Disorders [DISEASES] ,Otros calificadores::/terapia [Otros calificadores] ,Migraine ,Cross-Sectional Studie ,business.industry ,Headache ,técnicas de investigación::métodos epidemiológicos::recopilación de datos::encuestas y cuestionarios [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,General Medicine ,Other subheadings::/therapy [Other subheadings] ,medicine.disease ,Refractory migraine ,Anesthesiology and Pain Medicine ,Cross-Sectional Studies ,Burden ,Medicine ,Neurology (clinical) ,Level of care ,business ,Resistant migraine ,Migraine care ,Human ,Research Article - Abstract
Background New treatments are currently offering new opportunities and challenges in clinical management and research in the migraine field. There is the need of homogenous criteria to identify candidates for treatment escalation as well as of reliable criteria to identify refractoriness to treatment. To overcome those issues, the European Headache Federation (EHF) issued a Consensus document to propose criteria to approach difficult-to-treat migraine patients in a standardized way. The Consensus proposed well-defined criteria for resistant migraine (i.e., patients who do not respond to some treatment but who have residual therapeutic opportunities) and refractory migraine (i.e., patients who still have debilitating migraine despite maximal treatment efforts). The aim of this study was to better understand the perceived impact of resistant and refractory migraine and the attitude of physicians involved in migraine care toward those conditions. Methods We conducted a web-questionnaire-based cross-sectional international study involving physicians with interest in headache care. Results There were 277 questionnaires available for analysis. A relevant proportion of participants reported that patients with resistant and refractory migraine were frequently seen in their clinical practice (49.5% for resistant and 28.9% for refractory migraine); percentages were higher when considering only those working in specialized headache centers (75% and 46% respectively). However, many physicians reported low or moderate confidence in managing resistant (8.1% and 43.3%, respectively) and refractory (20.7% and 48.4%, respectively) migraine patients; confidence in treating resistant and refractory migraine patients was different according to the level of care and to the number of patients visited per week. Patients with resistant and refractory migraine were infrequently referred to more specialized centers (12% and 19%, respectively); also in this case, figures were different according to the level of care. Conclusions This report highlights the clinical relevance of difficult-to-treat migraine and the presence of unmet needs in this field. There is the need of more evidence regarding the management of those patients and clear guidance referring to the organization of care and available opportunities.
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- 2021
7. “Headache yesterday” at work. Pilot study of headache impact in an active workforce
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Gil-Gouveia, R., primary
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- 2021
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8. A novel KIF5a mutation identified in two-family members with spastic paraplegia type 10
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Oliveira, R., Maruta, C., and Gil-Gouveia, R.
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- 2021
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9. The impact of cognitive symptoms on migraine attack related disability: EP3232
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Gil Gouveia, R., Oliveira, A. G., and Martins, I. P.
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- 2014
10. Autonomic features in cluster headache. Exploratory factor analysis
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Gil Gouveia, R., Parreira, E., and Pavão Martins, I.
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- 2005
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11. Pleomorphic xanthoastrocytoma of the cerebellum: illustrated review
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Gil-Gouveia, R., Cristino, N., Farias, J. P., Trindade, A., Ruivo, N. S., and Pimentel, J.
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- 2004
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12. Blood biomarkers associated with inflammation predict poor prognosis in cerebral venous thrombosis
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Aguiar de Sousa, D., primary, Pereira‐Santos, M. C., additional, Serra‐Caetano, A., additional, Lucas Neto, L., additional, Sousa, A. L., additional, Gabriel, D., additional, Correia, M., additional, Gil‐Gouveia, R., additional, Oliveira, R., additional, Penas, S., additional, Carvalho Dias, M., additional, Correia, M. A., additional, Carvalho, M., additional, Sousa, A. E., additional, Canhão, P., additional, and Ferro, J. M., additional
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- 2020
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13. Migraine, headaches and cognition: P1471
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Martins, I. P., Gil-Gouveia, R., Silva, C., Maruta, C., and Gouveia, A.
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- 2010
14. Trigeminal activation and ocular autonomic dysfunction after stimulation of the posterior hypothalamus: SC303
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Gil-Gouveia, R. and Silva-Carvalho, L.
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- 2009
15. Neuropsychiatric side-effects of lidocaine: examples from the treatment of headache and a review
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Gil-Gouveia, R and Goadsby, P J
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- 2009
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16. Headache service quality: The role of specialized headache centres within structured headache services, and suggested standards and criteria as centres of excellence
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Steiner, T.J. Göbel, H. Jensen, R. Lampl, C. Paemeleire, K. Linde, M. Braschinsky, M. Mitsikostas, D. Gil-Gouveia, R. Katsarava, Z. European Headache Federation Lifting The Burden Global Campaign against Headache
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In joint initiatives, the European Headache Federation and Lifting The Burden have described a model of structured headache services (with their basis in primary care), defined service quality in this context, and developed practical methods for its evaluation. Here, in a continuation of the service quality evaluation programme, we set out ten suggested role- and performance-defining standards for specialized headache centres operating as an integral component of these services. Verifiable criteria for evaluation accompany each standard. The purposes are five-fold: (i) to inspire and promote, or stimulate the establishment of, specialized headache centres as centres of excellence; (ii) to define the role of such centres within optimally structured and organized national headache services; (iii) to set out criteria by which such centres may be recognized as exemplary in their fulfilment of this role; (iv) to provide the basis for, and to initiate and motivate, collaboration and networking between such centres both nationally and internationally; (v) ultimately to improve the delivery and quality of health care for headache. © 2019 The Author(s).
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- 2019
17. Headaches Associated With Refractive Errors: Myth or Reality?
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Gil-Gouveia, R. and Martins, I. P.
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- 2002
18. EHMTI-0193. The impact of cognitive symptoms on migraine attack related disability
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Gil-Gouveia, R, Oliveira, AG, and Martins, IP
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- 2014
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19. Headache service quality evaluation: implementation of quality indicators in primary care in Europe.
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Lenz, B., Katsarava, Z., Gil-Gouveia, R., Karelis, G., Kaynarkaya, B., Meksa, L., Oliveira, E., Palavra, F., Rosendo, I., Sahin, M., Silva, B., Uludüz, D., Ural, Y. Z., Varsberga-Apsite, I., Zengin, S. T., Zvaune, L., and Steiner, T. J.
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HEADACHE diagnosis ,HEADACHE treatment ,MEDICAL quality control ,KEY performance indicators (Management) ,HEALTH services accessibility ,PROFESSIONS ,HUMAN comfort ,INTERVIEWING ,INDIVIDUALIZED medicine ,PATIENT satisfaction ,HEALTH outcome assessment ,PRIMARY health care ,HUMAN services programs ,CLINICAL medicine ,QUESTIONNAIRES ,MEDICAL referrals ,PATIENT education ,PATIENT safety - Abstract
Background: Lifting The Burden (LTB) and European Headache Federation (EHF) have developed a set of headache service quality indicators, successfully tested in specialist headache centres. Their intended application includes all levels of care. Here we assess their implementation in primary care. Methods: We included 28 primary-care clinics in Germany (4), Turkey (4), Latvia (5) and Portugal (15). To implement the indicators, we interviewed 111 doctors, 92 nurses and medical assistants, 70 secretaries, 27 service managers and 493 patients, using the questionnaires developed by LTB and EHF. In addition, we evaluated 675 patients' records. Enquiries were in nine domains: diagnosis, individualized management, referral pathways, patient education and reassurance, convenience and comfort, patient satisfaction, equity and efficiency of headache care, outcome assessment and safety. Results: The principal finding was that Implementation proved feasible and practical in primary care. In the process, we identified significant quality deficits. Almost everywhere, histories of headache, especially temporal profiles, were captured and/or assessed inaccurately. A substantial proportion (20%) of patients received non-specific ICD codes such as R51 ("headache") rather than specific headache diagnoses. Headache-related disability and quality of life were not part of routine clinical enquiry. Headache diaries and calendars were not in use. Waiting times were long (e.g., about 60 min in Germany). Nevertheless, most patients (> 85%) expressed satisfaction with their care. Almost all the participating clinics provided equitable and easy access to treatment, and follow-up for most headache patients, without unnecessary barriers. Conclusions: The study demonstrated that headache service quality indicators can be used in primary care, proving both practical and fit for purpose. It also uncovered quality deficits leading to suboptimal treatment, often due to a lack of knowledge among the general practitioners. There were failures of process also. These findings signal the need for additional training in headache diagnosis and management in primary care, where most headache patients are necessarily treated. More generally, they underline the importance of headache service quality evaluation in primary care, not only to identify-quality failings but also to guide improvements. This study also demonstrated that patients' satisfaction is not, on its own, a good indicator of service quality. [ABSTRACT FROM AUTHOR]
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- 2021
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20. Blood biomarkers associated with inflammation predict poor prognosis in cerebral venous thrombosis: a multicenter prospective observational study.
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Aguiar de Sousa, D., Pereira‐Santos, M. C., Serra‐Caetano, A., Lucas Neto, L., Sousa, A. L., Gabriel, D., Correia, M., Gil‐Gouveia, R., Oliveira, R., Penas, S., Carvalho Dias, M., Correia, M. A., Carvalho, M., Sousa, A. E., Canhão, P., and Ferro, J. M.
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CEREBRAL embolism & thrombosis ,VENOUS thrombosis ,BLOOD-brain barrier ,BIOMARKERS ,SINUS thrombosis ,RECEIVER operating characteristic curves - Abstract
Background and purpose: Experimental studies suggest inflammation can contribute to blood barrier disruption and brain injury in cerebral venous thrombosis (CVT). We aimed to determine whether blood biomarkers of inflammation were associated with the evolution of brain lesions, persistent venous occlusion or functional outcome in patients with CVT. Methods: Pathophysiology of Venous Infarction—Prediction of Infarction and Recanalization in CVT (PRIORITy‐CVT) was a multicenter prospective cohort study of patients with newly diagnosed CVT. Evaluation of neutrophil‐to‐lymphocyte ratio (NLR) and C‐reactive protein (CRP) concentrations in peripheral blood samples was performed at admission in 62 patients. Additional quantification of interleukin (IL)‐6 was performed at day 1, 3 and 8 in 35 patients and 22 healthy controls. Standardized magnetic resonance imaging was performed at day 1, 8 and 90. Primary outcomes were early evolution of brain lesion, early recanalization and functional outcome at 90 days. Results: Interleukin‐6 levels were increased in patients with CVT with a peak at baseline. IL‐6, NLR and CRP levels were not related with brain lesion outcomes or early recanalization but had a significant association with unfavourable functional outcome at 90 days (IL‐6: OR = 1.28, 95% CI: 1.05–1.56, P = 0.046; NLR: OR = 1.39, 95% CI: 1.4–1.87, P = 0.014; CRP: OR = 1.756, 95% CI: 1.010–3.051, P = 0.029). Baseline IL‐6 had the best discriminative capacity, with an area under the receiver operating characteristic curve to predict unfavourable functional outcome of 0.74 (P = 0.031). Conclusions: Increased baseline levels of NLR, CRP and IL‐6 may serve as new predictive markers of worse functional prognosis at 90 days in patients with CVT. No association was found between inflammatory markers and early evolution of brain lesion or venous recanalization. [ABSTRACT FROM AUTHOR]
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- 2021
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21. Sequential brief neuropsychological evaluation of migraineurs is identical to controls
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Gil-Gouveia, R., primary, Oliveira, A. G., additional, and Martins, I. P., additional
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- 2015
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22. A short battery to evaluate cognitive dysfunction in migraine
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Gil-Gouveia, R., primary, Oliveira, A., additional, and Martins, I.P., additional
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- 2013
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23. Sequential brief neuropsychological evaluation of migraineurs is identical to controls.
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Gil‐Gouveia, R., Oliveira, A. G., and Martins, I. P.
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MIGRAINE diagnosis , *HEADACHE treatment , *MIGRAINE , *NEUROPSYCHOLOGICAL tests , *COGNITIVE therapy , *PRACTICE effects - Abstract
Background Evidence of attack-related cognitive dysfunction in migraine is growing. Controversy exists on whether cognitive dysfunction, mainly executive, may persist between attacks. Measuring the impact of cognitive function is gaining importance in clinical and research settings in migraine. Objective To compare the performance of interictal migraine patients to controls in an assembled neuropsychological battery focused on executive functions and to study the practice effect of its repeated applications. Method Assembly of the battery that was then applied twice within 6 weeks to interictal migraineurs and matched healthy controls. Results Migraine patients ( n = 24) and controls ( n = 24) had similar performance in both applications of the battery. There was a slight practice effect between the first and second evaluation, significant in Stroop Interference test ( P = 0.002, multiplicity corrected); a meaningful score change was determined for each raw test scores. Conclusions Interictal migraineurs and controls performance is identical in a brief cognitive battery focused on executive functions. Repeated applications produced a practice effect that was quantified. [ABSTRACT FROM AUTHOR]
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- 2016
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24. Validation of the Portuguese version of ID-MIGRAINE.
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Gil-Gouveia R and Martins I
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Background.- Migraine is a highly prevalent disorder that imposes an important burden of disability to patients and has social and economic impact in developed countries. A good screening tool for migraine diagnosis is useful to improve disease identification and therapeutic approaches, hopefully reducing the burden of migraine. Although Portuguese is currently the sixth most spoken language in the world, no migraine screening instrument exists in Portuguese. Objective.- To validate the Portuguese version of ID-Migraine[TM]. Methods.- Consecutive adults of 2 headache outpatient clinics in Lisbon, Portugal fulfilled the Portuguese version of ID-Migraine[TM] before evaluation by a trained neurologist in clinic, blinded to the questionnaire's results. The gold standard was the neurologists' clinical diagnosis, according to the International Classification of Headache Disorders, 2nd edition. A subset of patients was randomly selected to revaluation, in order to determine test-retest reliability. The validity measures of the test were calculated. Results.- A total of 142 patients were included, 83.8% of which women, with an age average of 39.2 years. Clinical diagnosis of migraine was made in 63.4% of the patients. The Portuguese version of ID-Migraine[TM] presented a sensitivity of 0.94 (95% CI 0.87-0.97), specificity of 0.60 (95% CI 0.46-0.73) and a positive predictive value of 0.80 (95% CI 0.71-0.87). Calculated Cronbachs' alpha was 0.78 and kappa coefficient 0.60. Conclusions.- The Portuguese version of ID-Migraine[TM] was of easy and rapid application and well accepted by patients. Its validity measures were identical to the 3 other versions of the same questionnaire - English (original), Italian, and Turkish. The Portuguese version of ID-Migraine[TM] is a valid screening tool for migraine, the first that can be used in Portuguese speaking communities although the low literacy rates in some of these countries may prevent its generalized application throughout the world. [ABSTRACT FROM AUTHOR]
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- 2010
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25. Poster Presentations.
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Pavãa-Martins, I., Gil-Gouveia, R., João-Lobo-Antunes, J., Lisotto, C., Dainese, F., Maggioni, F., Parreira, E.P., Tomé, A., Guoveia, R.G., Martins, I.P., D'Amico, D., Rigamonti, A., Solari, A., Leone, M., Usai, S., Grazzi, L., Bussone, G., Mea, E., and Broggi, G.
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CLUSTER headache , *HEADACHE - Abstract
Presents abstracts of several studies on cluster headache. 'Cluster headache without pain,' by I. Pavao-Martins, R. Gil-Gouveia and J. Joao-Lobo-Antunes; 'Hemicrania continua with contralateral episodic cluster headache: a case report,' by C. Lisotto, F. Dainese and F. Maggioni; 'Pain-relieving measures and behaviour during cluster headache attacks,' by E.P. Parreira, A. Tome, R.G. Gouveia and I.P. Martins.
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- 2002
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26. Transcranial Doppler findings in a population with clinical probable reversible cerebral vasoconstriction syndrome
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Oliveira, R., Inácio, N., Baptista, P., and Gil-Gouveia, R.
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To describe transcranial Doppler (TCD) findings in a population with clinical probable RCVS. Exploratory objectives included the study of clinical characteristics of probable RCVS patients with and without spasm detected by TCD.
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- 2021
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27. Relevant factors for neurologists to define effectiveness of migraine preventive drugs and take decisions on treatment. My-LIFE European Delphi survey
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Shazia Afridi, Anne Donnet, Raquel Gil-Gouveia, Astrid Gendolla, Cristina Tassorelli, Patricia Pozo-Rosich, Anne-Christine Poole, Gisela M. Terwindt, Rainel Sanchez-De La Rosa, Institut Català de la Salut, [Pozo-Rosich P] Unitat de Cefalea, Servei de Neurologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Grup de Recerca en Cefalea i Dolor Neurològic, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. [Gil-Gouveia R] Headache Center, Neurology Department, Hospital da Luz, Lisboa, Portugal. [Donnet A] Pain Department, Timone Hospital, Marseille, France. [Poole AC] Private Practice: Oslo Headache Centre, Oslo, Norway. [Gendolla A] Private Practice: Essen, Germany. [Afridi S] Headache Service, Department of Neurology, Guy’s and St Thomas’ NHS Trust, London, UK, and Vall d'Hebron Barcelona Hospital Campus
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Otros calificadores::Otros calificadores::/prevención & control [Otros calificadores] ,medicine.medical_specialty ,enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::trastornos con cefaleas::cefaleas primarias::trastornos migrañosos [ENFERMEDADES] ,Acute migraine ,Migraine Disorders ,Delphi method ,MEDLINE ,Qüestionaris ,Logistic regression ,Other subheadings::Other subheadings::/prevention & control [Other subheadings] ,Surveys and Questionnaires ,Health care ,medicine ,Humans ,Migranya - Prevenció ,In patient ,Neurologists ,Intensive care medicine ,Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Headache Disorders::Headache Disorders, Primary::Migraine Disorders [DISEASES] ,business.industry ,diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,Original Articles ,Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,medicine.disease ,Conjoint analysis ,Treatment Outcome ,Ciencias de la información::análisis de sistemas::técnica Delfos [CIENCIA DE LA INFORMACIÓN] ,Anesthesiology and Pain Medicine ,Pharmaceutical Preparations ,Migraine ,Avaluació de resultats (Assistència sanitària) ,Information Science::Systems Analysis::Delphi Technique [INFORMATION SCIENCE] ,Original Article ,business - Abstract
Mètode Delphi; Eficàcia dels fàrmacs preventius de la migranya Delphi survey; Effectiveness of migraine preventive drugs Método Delfos; Eficacia de los medicamentos preventivos contra la migraña Background Clinical guidelines agree that preventive treatment should be considered in patients with uncontrolled migraine despite acute medications or patients with ≥4 migraine days per month. However, the criteria to define the effectiveness of treatment and the factors that inform the decision to (dis)continue it are not clearly defined in clinical practice. Methods Overall, 148 healthcare practitioners from five European countries completed a two-wave questionnaire. The Steering Committee defined a simulated set of 108 migraine patient profiles based on the combination of five factors (frequency of the attacks, intensity of the attacks, use of acute migraine medications, patient perception and presence/absence of tolerable side effects). These profiles were used in a Delphi survey among European neurologists to identify the criteria that should be used to decide treatment response and continuation using a conjoint analysis approach. Results Consensus was reached for 82/108 (76%) of profiles regarding treatment response, and for 86/108 (80%) regarding treatment continuation. Multivariable logistic regression analysis showed that a ≥50% reduction in the use of acute migraine medications and positive patient's perception of treatment were the most important factors that lead to the decision of continuing (combined factors, OR = 18.3, 95% CI 13.4–25.05). Conclusions This survey identifies two relevant outcome measures: one objective (use of acute migraine treatment medications) and one subjective (positive patient perception) that guide the clinician decision to continue preventive treatment in migraine patients. Significance In clinical practice, criteria to define the effectiveness of migraine preventive treatment and factors that guide treatment stop or continuation are not clearly defined. In this simulated clinical setting study, a reduction in the use of acute migraine medications was the factor associated with preventive treatment effectiveness definition. This study also revealed that factors strongly associated with the decision of treatment continuation in real life are the acute migraine medications use and a positive patient's perception of treatment effectiveness. Novartis Pharma AG financially supported the development of this project, the medical writing assistance and the page processing charges for this article. The authors have received no payment to write this article.
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- 2021
28. Impact of truncating diffusion MRI scans on diffusional kurtosis imaging.
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Fouto AR, Henriques RN, Golub M, Freitas AC, Ruiz-Tagle A, Esteves I, Gil-Gouveia R, Silva NA, Vilela P, Figueiredo P, and Nunes RG
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- Humans, Female, Adult, Anisotropy, Computer Simulation, Signal-To-Noise Ratio, Reproducibility of Results, Image Interpretation, Computer-Assisted methods, Diffusion Tensor Imaging methods, Image Processing, Computer-Assisted methods, Healthy Volunteers, Diffusion Magnetic Resonance Imaging methods, Brain diagnostic imaging, Algorithms
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Objective: Diffusional kurtosis imaging (DKI) extends diffusion tensor imaging (DTI), characterizing non-Gaussian diffusion effects but requires longer acquisition times. To ensure the robustness of DKI parameters, data acquisition ordering should be optimized allowing for scan interruptions or shortening. Three methodologies were used to examine how reduced diffusion MRI scans impact DKI histogram-metrics: 1) the electrostatic repulsion model (Opt
EEM ); 2) spherical codes (OptSC ); 3) random (RandomTRUNC )., Materials and Methods: Pre-acquired diffusion multi-shell data from 14 female healthy volunteers (29±5 years) were used to generate reordered data. For each strategy, subsets containing different amounts of the full dataset were generated. The subsampling effects were assessed on histogram-based DKI metrics from tract-based spatial statistics (TBSS) skeletonized maps. To evaluate each subsampling method on simulated data at different SNRs and the influence of subsampling on in vivo data, we used a 3-way and 2-way repeated measures ANOVA, respectively., Results: Simulations showed that subsampling had different effects depending on DKI parameter, with fractional anisotropy the most stable (up to 5% error) and radial kurtosis the least stable (up to 26% error). RandomTRUNC performed the worst while the others showed comparable results. Furthermore, the impact of subsampling varied across distinct histogram characteristics, the peak value the least affected (OptEEM : up to 5% error; OptSC : up to 7% error) and peak height (OptEEM : up to 8% error; OptSC : up to 11% error) the most affected., Conclusion: The impact of truncation depends on specific histogram-based DKI metrics. The use of a strategy for optimizing the acquisition order is advisable to improve DKI robustness to exam interruptions., (© 2024. The Author(s).)- Published
- 2024
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29. Involvement of the cerebellum in structural connectivity enhancement in episodic migraine.
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Matoso A, Fouto AR, Esteves I, Ruiz-Tagle A, Caetano G, da Silva NA, Vilela P, Gil-Gouveia R, Nunes RG, and Figueiredo P
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- Humans, Female, Adult, Young Adult, Neural Pathways diagnostic imaging, Neural Pathways physiopathology, Nerve Net diagnostic imaging, Nerve Net physiopathology, Male, Middle Aged, Cerebellum diagnostic imaging, Cerebellum physiopathology, Cerebellum pathology, Connectome, Migraine Disorders diagnostic imaging, Migraine Disorders physiopathology, Migraine Disorders pathology, Magnetic Resonance Imaging
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Background: The pathophysiology of migraine remains poorly understood, yet a growing number of studies have shown structural connectivity disruptions across large-scale brain networks. Although both structural and functional changes have been found in the cerebellum of migraine patients, the cerebellum has barely been assessed in previous structural connectivity studies of migraine. Our objective is to investigate the structural connectivity of the entire brain, including the cerebellum, in individuals diagnosed with episodic migraine without aura during the interictal phase, compared with healthy controls., Methods: To that end, 14 migraine patients and 15 healthy controls were recruited (all female), and diffusion-weighted and T1-weighted MRI data were acquired. The structural connectome was estimated for each participant based on two different whole-brain parcellations, including cortical and subcortical regions as well as the cerebellum. The structural connectivity patterns, as well as global and local graph theory metrics, were compared between patients and controls, for each of the two parcellations, using network-based statistics and a generalized linear model (GLM), respectively. We also compared the number of connectome streamlines within specific white matter tracts using a GLM., Results: We found increased structural connectivity in migraine patients relative to healthy controls with a distinct involvement of cerebellar regions, using both parcellations. Specifically, the node degree of the posterior lobe of the cerebellum was greater in patients than in controls and patients presented a higher number of streamlines within the anterior limb of the internal capsule. Moreover, the connectomes of patients exhibited greater global efficiency and shorter characteristic path length, which correlated with the age onset of migraine., Conclusions: A distinctive pattern of heightened structural connectivity and enhanced global efficiency in migraine patients compared to controls was identified, which distinctively involves the cerebellum. These findings provide evidence for increased integration within structural brain networks in migraine and underscore the significance of the cerebellum in migraine pathophysiology., (© 2024. The Author(s).)
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- 2024
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30. Redefining migraine prevention: early treatment with anti-CGRP monoclonal antibodies enhances response in the real world.
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Caronna E, Gallardo VJ, Egeo G, Vázquez MM, Castellanos CN, Membrilla JA, Vaghi G, Rodríguez-Montolio J, Fabregat Fabra N, Sánchez-Caballero F, Jaimes Sánchez A, Muñoz-Vendrell A, Oliveira R, Gárate G, González-Osorio Y, Guisado-Alonso D, Ornello R, Thunstedt C, Fernández-Lázaro I, Torres-Ferrús M, Alpuente A, Torelli P, Aurilia C, Pére RL, Castrillo MJR, Icco R, Sances G, Broadhurst S, Ong HC, García AG, Campoy S, Sanahuja J, Cabral G, Beltrán Blasco I, Waliszewska-Prosół M, Pereira L, Layos-Romero A, Luzeiro I, Dorado L, Álvarez Escudero MR, May A, López-Bravo A, Martins IP, Sundal C, Irimia P, Lozano Ros A, Gago-Veiga AB, Juanes FV, Ruscheweyh R, Sacco S, Cuadrado-Godia E, García-Azorín D, Pascual J, Gil-Gouveia R, Huerta-Villanueva M, Rodriguez-Vico J, Viguera Romero J, Obach V, Santos-Lasaosa S, Ghadiri-Sani M, Tassorelli C, Díaz-de-Terán J, Díaz Insa S, Oria CG, Barbanti P, and Pozo-Rosich P
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- Humans, Male, Female, Middle Aged, Adult, Prospective Studies, Treatment Outcome, Calcitonin Gene-Related Peptide immunology, Calcitonin Gene-Related Peptide antagonists & inhibitors, Antibodies, Monoclonal, Humanized therapeutic use, Migraine Disorders prevention & control, Migraine Disorders drug therapy, Antibodies, Monoclonal therapeutic use
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Background: Anti-CGRP monoclonal antibodies (anti-CGRP MAbs) are approved and available treatments for migraine prevention. Patients do not respond alike and many countries have reimbursement policies, which hinder treatments to those who might respond. This study aimed to investigate clinical factors associated with good and excellent response to anti-CGRP MAbs at 6 months., Methods: European multicentre, prospective, real-world study, including high-frequency episodic or chronic migraine (CM) patients treated since March 2018 with anti-CGRP MAbs. We defined good and excellent responses as ≥50% and ≥75% reduction in monthly headache days (MHD) at 6 months, respectively. Generalised mixed-effect regression models (GLMMs) were used to identify variables independently associated with treatment response., Results: Of the 5818 included patients, 82.3% were females and the median age was 48.0 (40.0-55.0) years. At baseline, the median of MHD was 20.0 (14.0-28.0) days/months and 72.2% had a diagnosis of CM. At 6 months (n=4963), 56.5% (2804/4963) were good responders and 26.7% (1324/4963) were excellent responders. In the GLMM model, older age (1.08 (95% CI 1.02 to 1.15), p=0.016), the presence of unilateral pain (1.39 (95% CI 1.21 to 1.60), p<0.001), the absence of depression (0.840 (95% CI 0.731 to 0.966), p=0.014), less monthly migraine days (0.923 (95% CI 0.862 to 0.989), p=0.023) and lower Migraine Disability Assessment at baseline (0.874 (95% CI 0.819 to 0.932), p<0.001) were predictors of good response (AUC of 0.648 (95% CI 0.616 to 0.680)). These variables were also significant predictors of excellent response (AUC of 0.691 (95% CI 0.651 to 0.731)). Sex was not significant in the GLMM models., Conclusions: This is the largest real-world study of migraine patients treated with anti-CGRP MAbs. It provides evidence that higher migraine frequency and greater disability at baseline reduce the likelihood of responding to anti-CGRP MAbs, informing physicians and policy-makers on the need for an earlier treatment in order to offer the best chance of treatment success., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/disclosure-of-interest/ and declare: EC has received honoraria from Novartis, Chiesi, Lundbeck, MedScape; his salary has been partially funded by Río Hortega grant Acción Estratégica en Salud 2017–2020, Instituto de Salud Carlos III (CM20/00217). He is a junior editor for Cephalalgia. GE received travel grants and honoraria from Eli-Lilly, Novartis, Lusofarmaco, New Penta and Ecupharma. CNC has received honoraria for advisories, educational or commercial symposia from: Abbvie-Allergan, Kern Pharma, Chiesi, Lilly, Lundbeck, Novartis and Teva Pharmaceuticals And has participated as subinvestigator in Clinical Trials for: Abbvie-Allergan, Amgen, Biohaven, Lilly, Lundbeck, Pfizer and Teva Pharmaceuticals. JAM has received honoraria as consultant and/or speaker for Lilly, Novartis, Teva. FS-C received honoraria from Novartis, Lilly, TEVA, Abbvie. AM has received honoraria from Teva, Lilly, Roche, UCB, Bial, Chiesi, Allergan, Esai, Zambon, Kern Pharma, Pfizer, Biogen Idec, Novartis, TEVA, Merck, Janssen, Neuraxpharm, Genzyme, Sanofi, Bayer, Almirall and/or Celgene. JS received honoraria from Allergan, Lilly, Teva, Novartis. IBB received honoraria for presentations from Novartis, Lilly, Teva, Lundbeck and Abbvie. MW-P received honoraria from Pfizer, Allergan-Abbvie, TEVA, Polpharma. MW-P is member of Editorial Board: The Journal of Headache and Pain. LP received honoraria from Pfizer, Lilly, Abbvie, TEVA, Novartis. AL-R received honoraria for Abbvie, Lilly, Novartis and Teva. IL received honoraria from Novartis, Abbvie, Teva, Eisai, Tecnifar and Bial. LD received honoraria as a speaker for Allergan, Lilly, Teva and Lundbeck. MRA-E, received honoraria from ABBVIE, Lilly, and Novartis. AM has no COI to declare. The University Clinic Hamburg got an unrestricted scientific grant from Novartis (2019-2023). IPM has received honoraria from Allergan Teva, Novartis, Lundbeck and Eli Lilly for lecturing or participating in advisory boards; is principal investigator for phase IV trials sponsored by Novartis, Lundbeck and Teva. CS has received personal fees for lectures/ advisory boards: Novartis, Abbvie and TEVA. PI received honoraria from TEVA, Novartis, Lilly, Abbvie, Lundbeck, Exeltis. ALR received honoraria from TEVA. ABG-V has received speaker honoraria and/or clinical advisor from Novartis, Lilly, TEVA, Exeltis, Chiesi, Abbvie, Pfizer and Lundbeck. RR has received travel grants and/or honoraria for lectures or advisory boards from Allergan/AbbVie, Hormosan, Lilly, Lundbeck, Novartis, Pfizer and Teva. SS reports consultant, speaker or advisory board fees from Abbott, Allergan/Abbvie, AstraZeneca, Bayer, Bristol Myers Squibb, Daiichi-Sankyo, Eli Lilly, Medscape, Medtronic, Novartis, Pfizer, Starmed, Teva and Uriach. EC-G received honoraria from TEVA. DGA has received personal compensation for consulting/advising from the WHO. Non-profit board membership in the Spanish Society of Neurology, and the European Union of Medical Specialist section of Neurology. Research funding from the Regional Health Administration (Gerencia Regional de Salud SACYL) in Castilla y Leon, Spain and Carlos III institute, Madrid, Spain. Speaker/travel grants/ clinical trials from Teva, Allergan, Amgen, Eli Lilly, Lundbeck, Novartis and Biohaven. JP has received honoraria from Abbvie, Lilly, Lundbeck, Novartis and Teva. RG-G received honoraria from Allergan/ Abbvie, Lilly, Lundbeck, Novartis, Pfizer, Tecnifar, Teva. MH-V has received honoraria for participating on advisory boards and for collaborations as consultant, scientific communications, speaker, research support as well as funding for travel and congress-attending expenses for Abbie-Allergan, Novartis, Lundbeck, Lilly, Almirall, Chiesi, Esai, Exeltis, Kern Pharma, Menarini, TEVA and Zambon. His research group has received research grants from Abbie-Allergan and has received funding for clinical trials from Lilly, Novartis, TEVA. JVR received honoraria from Novartis, Abbvie, Lilly, TEVA, Lundbeck. SS-L received honoraria from Allergan, Almirall, Amgen, Chiesi, Eisai, Exeltis, Lilly, Lündbeck, Novartis, Pfizer y Teva. MG-S has received honoraria and been involved in research, education and advisory boards with Teva, Lily, Novartis and Abbvie. CT received personal fees for participating in advisory or for speaking at scientific events from AbbVie, Allergan, Biohaven, Dompé, Eli Lilly, Lundbeck, Novartis and Teva. CT has received research funding from the European Commission, the Italian Ministry of Health and Migraine Research Foundation. JDdT has received honoraria as consultant and/or speaker for Lilly, Novartis, Teva. SDI has received honoraria for advisories, educational or commercial symposia from: Abbvie-Allergan, Fundació Universitat-Empresa, Ipsen Pharma, Kern Pharma, Lilly, Lundbeck, MSD-Organon, Novartis and Teva Pharmaceuticals And has participated as PI in Clinical Trials for: Abbvie-Allergan, Alder, Amgen, Biohaven, Ipsen Pharma, Lilly, Lundbeck, Pfizer and Teva Pharmaceuticals. CGO participated in clinical trials from Novartis, St Jude Medical, Lilly, Lundbeck; TEVA, Biohaven, Pfizer. CGO received honoraria as consultant for Novartis, Lilly, Allergan-abbvie, Lundbeck, TEVA, Pfizer. CGO received honoraria as speaker for Allergan-Abbvie, TEVA, Novartis,Lilly, Chiesi, MSD, Almirall. PB reports personal compensation for consulting, serving on a scientific advisory board, speaking, research support, collaborated for clinical trials or other activities with Abbvie, Alder, Allergan, Amgen, Angelini, Assosalute, Bayer, Biohaven, ElectroCore, Eli-Lilly, Fondazione Ricerca e Salute, GSK, Lundbeck, Lusofarmaco, 1MED, MSD, New Penta, Noema Pharma, Novartis, Pfizer, Stx-Med, Teva, Visufarma, Zambon and serves as President with Italian Association of Headache Sufferers. PP-R has received, in the last 3 years, honoraria as a consultant and speaker for: AbbVie, Biohaven, Chiesi, Eli Lilly, Lundbeck, Medscape, Novartis, Pfizer and Teva. Her research group has received research grants from AbbVie, Novartis and Teva; as well as, Instituto Salud Carlos III, EraNet Neuron, European Regional Development Fund (001-P-001682) under the framework of the FEDER Operative Programme for Catalunya 2014-2020 - RIS3CAT; has received funding for clinical trials from AbbVie, Amgen, Biohaven, Eli Lilly, Novartis, Teva. She is the Honorary Secretary of the International Headache Society. She is in the editorial board of Revista de Neurologia. She is an associate editor for Cephalalgia, Headache, Neurologia, The Journal of Headache and Pain and Frontiers of Neurology. She is a member of the Clinical Trials Guidelines Committee of the International Headache Society. She has edited the Guidelines for the Diagnosis and Treatment of Headache of the Spanish Neurological Society. She is the founder of www.midolordecabeza.org. PP-R does not own stocks from any pharmaceutical company. VJG, MMV, GV, JR-M, NFF, AJS, RO, GG, YG-O, GC, AL-B, FVJ, JR-V and VO reports no disclosures. RO reports personal fees from Eli Lilly, Novartis, Teva, and Pfizer, and non-financial support from Novartis, Teva, and Allergan/AbbVie. CT has received honoraria for lectures from TEVA, Lundbeck and for advisory boards from TEVA. He has received travel support from TEVA and Lundbeck. SS received honoraria from TEVA. AH declares no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. HB received honoraria from Novartis, Teva and Lundbeck. NPRP received honoraria from ABBVIE, Lilly and Novartis. CF received honoraria from Novartis and Abbvie. AAL received honoraria for Abbvie, Lilly, Novartis and Teva. EMS received a grant from the Portuguese Headache Society, supported by Teva. MTF has received honoraria from Allergan-AbbVie, Novartis, Chiesi and Teva. AA has received honoraria from Allergan-AbbVie, Novartis, Chiesi. PT received grants and honoria from Novartis, Teva, Eli-Lilly and Allergan. CA received travel grants from FB-Health, Lusofarmaco, Almirall, Eli-Lilly Novartis and Teva. RDI received speaker honoraria from Eli-Lilly, TEVA and Lundbeck. GS received personal fees as speaker or advisory board from Eli Lilly, Novartis, Teva, Lundbeck, Pfizer. SB has received honoraria from Teva. SC has received honoraria from Teva, Lilly, Roche, UCB, Bial, Chiesi, Allergan, Esai, Zambon, Kern Pharma, Pfizer, Biogen Idec, Novartis, TEVA, Merck, Janssen, Neuraxpharm, Genzyme, Sanofi, Bayer, Almirall and/or Celgene. EP reports personal fees from Novartis, Teva and Lilly. ALGP Research funding from the Regional Health Administration (Gerencia Regional de Salud SACYL) in Castilla y Leon, Spain. Speaker/travel grants/ clinical trials from Teva, Allergan, Amgen, Eli Lilly, Lundbeck, Novartis, Pfizer and Biohaven. AS has received honoraria for advisory boards and lectures from Allergan/AbbVie, Hormosan, Lilly, Lundbeck, Novartis, Sanofi, Teva. AGM has received speaker honoraria from TEVA. SQ has received speaker honoraria from Novartis, Lilly and Exeltis. MSR has received consulting fees and honoraria for lectures/presentations from Eli Lily, Lundbeck, Novartis, Teva and Pfizer. Intellectual as Secretary of the European Headache Federation, Review Editor on the Editorial Board of Headache and Neurogenic Pain (specialty section of Frontiers in Neurology). Margarita Sanchez-del-Rio serves as a member of the Board of Directors in the European Headache Federation. ET has received personal fees for lectures/ advisory boards: Novartis, Eli Lilly, Abbvie, TEVA, Roche, Lundbeck, Pfizer, Biogen. Consultant for and owner of stocks and IP in Man & Science. Stocks and IP in Nordic Brain Tech and Keimon Medical. Non-personal research grants from EU, Norwegian Research Council, Dam foundation, KlinBeForsk. Commissioned research (non-personal): Lundbeck, Pfizer. BVP received honoraria from ABBVIE. AOD received honoraria from ABBVIE, Lilly, Teva, Novartis. MR received honoraria from Lilly, Novartis. BC received grants and honoria from Eli-Lilly, Novartis, Teva; SC received travel grants, honoraria for advisory boards, speaker panels or clinical investigation studies from Novartis, Teva, Lilly, Allergan, Abvie, Ibsa, Amgen, Angelini and Lundbeck; FF has received fees for participation on advisory boards, speaker honoraria or consulting activities from Angelini, Cristalfarma, Ecupharma, IBSA, Lundbeck, Novartis, PIAM, Teva; FdO received travel grant, honoraria as a speaker or for partecipating in advisory boards from Novartis, Teva, Neopharmed Gentili, Qbgroup srl, K link srl and Eli-Lilly; MA received grants from Novartis and Lilly; RR received honoraria for speaker panels from Teva, Lilly, Novartis, Allergan, Lundbeck; MZ received travel grants and honoraria from Novartis; MA received travel grants and honoraria from Novartis, Teva, Eli-Lilly and Lundbeck; CF received grants and honoraria from Novartis, Eli Lilly, TEVA, AIM group; AR received travel grants and honoraria from Teva and Eli-Lilly; SZ, RLP, MJRC, VGQ, HCO, SA, IKZ, DGA, IFL, BFP, SB, PRA, AC, AEU, AGG, IM, JPS, VC, AFR, YVE, MT, AS, AC, FZ and MA has no disclosures to declare., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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31. Efficacy and Safety of Erenumab for Nonopioid Medication Overuse Headache in Chronic Migraine: A Phase 4, Randomized, Placebo-Controlled Trial.
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Tepper SJ, Dodick DW, Lanteri-Minet M, Dolezil D, Gil-Gouveia R, Lucas C, Piasecka-Stryczynska K, Szabó G, Mikol DD, Chehrenama M, Chou DE, Yang Y, and Paiva da Silva Lima G
- Abstract
Importance: Patients with chronic migraine and medication overuse headaches (CM-MOH) represent a particularly burdened subpopulation. This trial provides first, to our knowledge, American Academy of Neurology class I evidence for a preventive therapy in CM-MOH., Objective: To assess erenumab efficacy and safety in patients with nonopioid CM-MOH., Design, Settings, and Participants: This randomized, double-blind, parallel-group, placebo-controlled trial took place at 67 centers in North America, Europe, and Australia from October 7, 2019, to November 2, 2022. This report reflects the primary analysis conducted in January 2023, using a database snapshot from December 1, 2022, which contains the complete dataset of the double-blind treatment period (DBTP). Participants included adults with CM-MOH who had 1 or more preventive treatment failure(s). There were 992 participants screened and 620 participants enrolled (584 in nonopioid cohort and 36 in opioid cohort)., Interventions: Erenumab, 70 mg, 140 mg, or placebo, once monthly for 24 weeks., Main Outcomes and Measures: The primary end point was MOH remission at month 6. Secondary end points included change from baseline in mean monthly acute headache medication days (AHMD) at month 6 and sustained MOH remission throughout the DBTP. Safety end points were adverse events and changes in vital signs., Results: The primary analysis population included 584 participants in the nonopioid-treated cohort with a mean age of 44 years and 482 participants were female (82.5%). Baseline demographics and disease characteristics were balanced across groups. At month 6, 134 participants in the erenumab, 140 mg group (69.1%) (odds ratio [OR], 2.01; 95% CI, 1.33-3.05; P < .001 vs placebo) and 117 in the erenumab, 70 mg group (60.3%) (OR, 1.37; 95% CI, 0.92-2.05; P = .13 vs placebo) achieved MOH remission vs 102 participants in the placebo group (52.6%). AHMD use was also reduced in the erenumab groups vs placebo. Least squares mean (standard error) change from baseline in average monthly AHMD was -9.4 (0.4) days in the erenumab, 140 mg group (difference from placebo, -2.7; 95% CI, -3.9 to -1.6; P < .001) and -7.8 (0.4) days in the erenumab, 70 mg group (difference from placebo, -1.2; 95% CI, -2.4 to -0.1; P = .03), vs -6.6 (0.4) days in the placebo group. MOH remission throughout the DBTP was sustained in 119 participants (61.3%,) 96 participants (49.5%), and 73 participants (37.6%) in the erenumab, 140 mg, 70 mg, and placebo groups, respectively. Adverse events were consistent with the known safety profile of erenumab. Treatment-emergent adverse events incidence in the combined erenumab group was 66.8% (259 participants; constipation 15.2% (59 participants) and COVID-19 13.9% (54 participants) were most common., Conclusions and Relevance: In this study, monthly, 140 mg, erenumab injections safely and effectively achieved MOH remission in patients with nonopioid CM-MOH within 6 months., Trial Registration: ClinicalTrials.gov Identifier: NCT03971071.
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- 2024
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32. European Headache Federation (EHF) critical re-appraisal and meta-analysis of oral drugs in migraine prevention - part 4: propranolol.
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Versijpt J, Deligianni C, Hussain M, Amin F, Reuter U, Sanchez-Del-Rio M, Uluduz D, Boucherie D, Zeraatkar D, MaassenVanDenBrink A, Sacco S, Lampl C, and Gil-Gouveia R
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- Humans, Administration, Oral, Randomized Controlled Trials as Topic, Propranolol therapeutic use, Propranolol administration & dosage, Migraine Disorders prevention & control, Migraine Disorders drug therapy, Adrenergic beta-Antagonists administration & dosage, Adrenergic beta-Antagonists therapeutic use
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Objective: The aim of this paper is to critically re-appraise the published trials assessing propranolol for migraine prophylaxis., Methods: We report methods and results following the Preferred Reporting Items for Systematic Reviews (PRISMA), by searching MEDLINE, EMBASE, Cochrane CENTRAL, and ClinicalTrials.gov for randomized trials of pharmacologic treatments for migraine prophylaxis. We included randomized trials that compared propranolol with placebo for migraine prophylaxis in adults. The outcomes of interest were informed by the Core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG) and include the proportion of patients who experience a 50% or more reduction in monthly migraine days, the reduction of monthly migraine days, and the number of adverse events leading to discontinuation. We assessed risk of bias by using a modified Cochrane RoB (risk of bias) 2.0 tool and the certainty of evidence by using the GRADE approach., Results: Our search yielded twenty trials (n = 1291 patients) eligible for data synthesis and analysis. The analysis revealed a moderate certainty evidence that propranolol leads to a reduction in monthly migraine days versus placebo (-1.27; 95% CI: -2.25 to -0.3). We found moderate certainty evidence that propranolol increases the proportion of patients who experience a 50% or more reduction in monthly migraine days, compared to placebo with a relative risk of 1.65 (95% CI 1.41 to 1.93); absolute risk difference: 179 more per 1,000 (95% CI 113 to 256). We found high certainty evidence that propranolol increases the proportion of patients who discontinue due to adverse events compared to placebo with a risk difference of 0.02 (95% CI 0.00 to 0.03); absolute risk difference: 20 more per 1,000 (95% CI 0 to 30)., Conclusions: The present meta-analysis shows that propranolol has a prophylactic role in migraine, with an overall acceptable tolerability profile. Combining these results with its long-standing use and its global availability at a low cost confirms its role as a first line agent in the prophylaxis of migraine., (© 2024. The Author(s).)
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- 2024
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33. Early Use of Erenumab vs Nonspecific Oral Migraine Preventives: The APPRAISE Randomized Clinical Trial.
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Pozo-Rosich P, Dolezil D, Paemeleire K, Stepien A, Stude P, Snellman J, Arkuszewski M, Stites T, Ritter S, Lopez Lopez C, Maca J, Ferraris M, and Gil-Gouveia R
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- Humans, Male, Female, Adult, Middle Aged, Administration, Oral, Calcitonin Gene-Related Peptide Receptor Antagonists administration & dosage, Calcitonin Gene-Related Peptide Receptor Antagonists therapeutic use, Patient Satisfaction, Treatment Outcome, Medication Adherence, Prospective Studies, Migraine Disorders drug therapy, Migraine Disorders prevention & control, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized administration & dosage
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Importance: Patients with migraine often cycle through multiple nonspecific preventive medications due to poor tolerability and/or inadequate efficacy leading to low adherence and increased disease burden., Objective: To compare the efficacy, tolerability, patient adherence, and patient satisfaction between erenumab and nonspecific oral migraine preventive medications (OMPMs) in patients with episodic migraine (EM) who had previously failed 1 or 2 preventive treatments., Design, Setting, and Participants: The 12-month prospective, interventional, global, multicenter, active-controlled, randomized clinical trial comparing sustained benefit of 2 treatment paradigms (erenumab qm vs oral prophylactics) in adult episodic migraine patients (APPRAISE) trial was a 12-month open-label, multicenter, active-controlled, phase 4 randomized clinical trial conducted from May 15, 2019, to October 1, 2021. This pragmatic trial was conducted at 84 centers across 17 countries. Overall, participants 18 years or older with a 12-month or longer history of migraine, and 4 or more but fewer than 15 monthly migraine days (MMDs) were included., Interventions: Patients were randomized (2:1) to receive erenumab or OMPMs. Dose adjustment was permitted (label dependent)., Main Outcomes and Measures: The primary end point was the proportion of patients completing 1 year of the initially assigned treatment and achieving a reduction of 50% or greater from baseline in MMDs at month 12. Secondary end points included the cumulative mean change from baseline in MMDs during the treatment period and the proportion of responders according to the Patients' Global Impression of Change (PGIC) scale at month 12 for patients taking the initially assigned treatment., Results: A total of 866 patients were screened, of whom 245 failed the screening and 621 completed the screening and baseline period. Of the 621 randomized patients (mean [SD] age, 41.3 [11.2] years; 545 female [87.8%]; 413 [66.5%] in the erenumab group; 208 [33.5%] in the OMPM group), 523 (84.2%) completed the treatment phase, and 98 (15.8%) discontinued the study. At month 12, significantly more patients assigned to erenumab vs OMPM achieved the primary end point (232 of 413 [56.2%] vs 35 of 208 [16.8%]; odds ratio [OR], 6.48; 95% CI, 4.28-9.82; P <.001). Compared with OMPMs, treatment with erenumab showed higher responder rate (314 of 413 [76.0%] vs 39 of 208 [18.8%]; OR, 13.75; 95% CI, 9.08-20.83; P <.001) on the PGIC scale (≥5 at month 12). Significant reduction in cumulative average MMDs was reported with erenumab treatment vs OMPM treatment (-4.32 vs -2.65; treatment difference [SE]: -1.67 [0.35] days; P < .001). Substantially fewer patients in the erenumab arm compared with the OMPM arm switched medication (9 of 413 [2.2%] vs 72 of 208 [34.6%]) and discontinued treatment due to adverse events (12 of 408 [2.9%] vs 48 of 206 [23.3%]). No new safety signals were identified., Conclusions and Relevance: Results of this randomized clinical trial demonstrated that earlier use of erenumab in patients with EM who failed 1 or 2 previous preventive treatments provided greater and sustained efficacy, safety, and adherence than continuous OMPM., Trial Registration: ClinicalTrials.gov Identifier: NCT03927144.
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- 2024
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34. CGRP-targeted medication in chronic migraine - systematic review.
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Oliveira R, Gil-Gouveia R, and Puledda F
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- Humans, Antibodies, Monoclonal therapeutic use, Receptors, Calcitonin Gene-Related Peptide, Calcitonin Gene-Related Peptide Receptor Antagonists pharmacology, Calcitonin Gene-Related Peptide Receptor Antagonists therapeutic use, Calcitonin Gene-Related Peptide therapeutic use, Migraine Disorders drug therapy
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Background: Chronic migraine is a highly debilitating condition that is often difficult to manage, particularly in the presence of medication overuse headache. Drugs targeting the calcitonin gene-related peptide (CGRP), or its receptor have shown promising results in treating this disorder., Methods: We searched Pubmed and Embase to identify randomized clinical trials and real-world studies reporting on the use of medication targeting the calcitonin gene-related peptide in patients with chronic migraine., Results: A total of 270 records were identified. Nineteen studies qualified for the qualitative analysis. Most studies reported on monoclonal antibodies targeting CGRP (anti-CGRP mAbs), that overall prove to be effective in decreasing monthly migraine days by half in about 27.6-61.4% of the patients. Conversion from chronic to episodic migraine was seen in 40.88% of the cases, and 29-88% of the patients stopped medication overuse. Obesity seems to be the main negative predictor of response to anti-CGRP mAbs. There is no evidence to suggest the superiority of one anti-CGRP mAb. Despite the lack of strong evidence, the combination of anti-CGRP medication with onabotulinumtoxinA in chronic migraine is likely to bring benefits for resistant cases. Atogepant is the first gepant to demonstrate a significant decrease in monthly migraine days compared to placebo in a recent trial. Further, anti-CGRP mAb and gepants have a good safety profile., Conclusion: There is strong evidence from randomized trials and real-world data to suggest that drugs targeting CGRP are a safe and effective treatment for chronic migraine., (© 2024. The Author(s).)
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- 2024
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35. CLOCK gene circannual expression in cluster headache.
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Oliveira R, Neves-Costa A, Pedroso D, Paixão T, Barros AB, Moita LF, and Gil-Gouveia R
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- Humans, Male, Female, Adult, Middle Aged, Circadian Rhythm, Seasons, Cluster Headache genetics, CLOCK Proteins genetics, CLOCK Proteins biosynthesis
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Background: Cluster headache is a primary headache disorder characterized by bouts with circadian and circannual patterns. The CLOCK gene has a central role in regulating circadian rhythms. Here, we investigate the circannual CLOCK expression in a population of cluster headache patients in comparison to matched controls., Methods: Patients with cluster headache were sampled two to four times over at least one year, both in or outside bouts, one week after each solstice and equinox. The expression of CLOCK was measured by quantitative real-time polymerase chain reaction (RT-PCR) in the peripheral blood., Results: This study included 50 patients and 58 matched controls. Among the patient population, composed of 42/50 males (84%) with an average age of 44.6 years, 45/50 (90%) suffered from episodic cluster headache. Two to four samples were collected from each patient adding up to 161 samples, 36 (22.3%) of which were collected within a bout. CLOCK expression for cluster headache patients was considerably different from that of the control population in winter (p-value mean = 0.006283), spring (p-value mean = 0.000006) and summer (p-value mean = 0.000064), but not in autumn (p-value mean = 0.262272). For each season transition, the variations in CLOCK expression were more pronounced in the control group than in the cluster headache population. No statistically significant differences were found between bout and non-bout samples. No individual factors (age, sex, circadian chronotype, smoking and coffee habits or history of migraine) were related to CLOCK expression., Conclusions: We observed that CLOCK expression in cluster headache patients fluctuates less throughout the year than in the control population. Bout activity and lifestyle factors do not seem to influence CLOCK expression., Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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- 2024
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36. Working memory during spontaneous migraine attacks: an fMRI study.
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Ruiz-Tagle A, Figueiredo P, Pinto J, Vilela P, Martins IP, and Gil-Gouveia R
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- Humans, Female, Memory, Short-Term, Headache, Prefrontal Cortex, Magnetic Resonance Imaging, Migraine Disorders diagnostic imaging
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Objective: To investigate the neural correlates of working memory during a spontaneous migraine attack compared to the interictal phase, using functional magnetic resonance imaging (fMRI)., Background: Cognitive disturbances are commonly observed during migraine attacks, particularly in the headache phase. However, the neural basis of these changes remains unknown., Methods: In a fMRI within-subject test-retest design study, eleven women (32 years of age, average) with episodic migraine were evaluated twice, first during a spontaneous migraine attack, and again in a pain-free period. Each session consisted in a cognitive assessment and fMRI while performing a working memory task (N-back)., Results: Cognitive test scores were lower during the ictal session than in the pain-free session. Regions typically associated with working memory were activated during the N-back task in both sessions. A voxel wise between session comparison showed significantly greater activation in the left frontal pole and orbitofrontal cortex during the attack relative to the interictal phase., Conclusion: Migraine patients exhibited greater activation of the left frontal pole and orbitofrontal cortex while executing a verbal working memory task during a spontaneous migraine attack when compared to the interictal state. Given the association of these regions with pain processing and inhibitory control, these findings suggest that patients recruit inhibitory areas to accomplish the cognitive task during migraine attacks, a neural signature of their cognitive difficulties., (© 2023. The Author(s).)
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- 2024
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37. Altered functional connectivity in a sensorimotor-insular network during spontaneous migraine attacks: A resting-state FMRI study.
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Araújo RP, Figueiredo P, Pinto J, Vilela P, Martins IP, and Gil-Gouveia R
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- Humans, Female, Magnetic Resonance Imaging methods, Brain diagnostic imaging, Brain Mapping methods, Migraine Disorders diagnostic imaging, Epilepsy
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Background: Previous functional magnetic resonance imaging studies have identified brain-connectivity alterations across multiple regions in people with migraine when compared to healthy controls. Few studies have focused on such changes throughout the different phases of the migraine cycle. We aimed to investigate functional connectivity during spontaneous occurring episodic migraine attacks, in comparison to interictal periods., Methods: Eleven women with episodic migraine without aura underwent two sessions of resting-state fMRI, during and outside of a spontaneous migraine attack. Functional connectivity changes were assessed across canonical resting-state networks, identified by independent component analysis. Significantly altered connectivity was correlated with migraine attack symptoms., Results: Decreased functional connectivity between subregions of the sensorimotor network (specifically, the primary somatosensory and motor cortices) and the posterior insula, bilaterally, was found during attacks. In both sessions, the functional connectivity between these regions was lower in patients who usually suffered longer attacks., Discussion: The sensorimotor and insular regions are involved in nociceptive, autonomic, and somatosensory processing so the finding of reduced connectivity between these structures within a migraine attack is likely associated to the perception of pain and the heighten sensitivity to stimuli experienced in this disorder., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)
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- 2023
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38. Rethinking headache as a global public health case model for reaching the SDG 3 HEALTH by 2030.
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Martelletti P, Leonardi M, Ashina M, Burstein R, Cho SJ, Charway-Felli A, Dodick DW, Gil-Gouveia R, Grazzi L, Lampl C, MaassenVanDenBrink A, Minen MT, Mitsikostas DD, Olesen J, Owolabi MO, Reuter U, Ruiz de la Torre E, Sacco S, Schwedt TJ, Serafini G, Surya N, Tassorelli C, Wang SJ, Wang Y, Wijeratne T, and Raggi A
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- Humans, Female, Aged, Sustainable Development, Public Health, Headache diagnosis, Headache therapy, Global Health, Acute Pain, Headache Disorders diagnosis, Headache Disorders epidemiology, Headache Disorders therapy
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The 2030 Agenda for Sustainable Development sets out, through 17 Sustainable Development Goals (SDGs), a path for the prosperity of people and the planet. SDG 3 in particular aims to ensure healthy lives and promote well-being for all at all ages and includes several targets to enhance health. This review presents a "headache-tailored" perspective on how to achieve SDG 3 by focusing on six specific actions: targeting chronic headaches; reducing the overuse of acute pain-relieving medications; promoting the education of healthcare professionals; granting access to medication in low- and middle-income countries (LMIC); implementing training and educational opportunities for healthcare professionals in low and middle income countries; building a global alliance against headache disorders. Addressing the burden of headache disorders directly impacts on populations' health, as well as on the possibility to improve the productivity of people aged below 50, women in particular. Our analysis pointed out several elements, and included: moving forward from frequency-based parameters to define headache severity; recognizing and managing comorbid diseases and risk factors; implementing a disease management multi-modal management model that incorporates pharmacological and non-pharmacological treatments; early recognizing and managing the overuse of acute pain-relieving medications; promoting undergraduate, postgraduate, and continuing medical education of healthcare professionals with specific training on headache; and promoting a culture that favors the recognition of headaches as diseases with a neurobiological basis, where this is not yet recognized. Making headache care more sustainable is an achievable objective, which will require multi-stakeholder collaborations across all sectors of society, both health-related and not health-related. Robust investments will be needed; however, considering the high prevalence of headache disorders and the associated disability, these investments will surely improve multiple health outcomes and lift development and well-being globally., (© 2023. Springer-Verlag Italia S.r.l., part of Springer Nature.)
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- 2023
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39. European Headache Federation (EHF) critical reappraisal and meta-analysis of oral drugs in migraine prevention - part 3: topiramate.
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Raffaelli B, García-Azorín D, Boucherie DM, Amin FM, Deligianni CI, Gil-Gouveia R, Kirsh S, Lampl C, Sacco S, Uluduz D, Versijpt J, MaassenVanDenBrink A, Zeraatkar D, Sanchez-Del-Rio M, and Reuter U
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- Adult, Humans, Topiramate adverse effects, Headache, Patient Satisfaction, Transcription Factors therapeutic use, Migraine Disorders prevention & control, Migraine Disorders drug therapy
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Objective: Topiramate is a repurposed first-line treatment for migraine prophylaxis. The aim of this systematic review and meta-analysis is to critically re-appraise the existing evidence supporting the efficacy and tolerability of topiramate., Methods: A systematic search in MEDLINE, EMBASE, Cochrane CENTRAL, and ClinicalTrials.gov was performed for trials of pharmacological treatment in migraine prophylaxis as of August 13, 2022, following the Preferred Reporting Items for Systematic Reviews (PRISMA). Randomized controlled trials in adult patients that used topiramate for the prophylactic treatment of migraine, with placebo as active comparator, were included. Two reviewers independently screened the retrieved studies and extracted all data. Outcomes of interest were the 50% responder rates, the reduction in monthly migraine days, and adverse events leading to treatment discontinuation. Results were pooled and meta-analyzed, with sensitivity analysis based on the risk of bias of the studies, the monthly migraine days at baseline, and the previous use of other prophylactic treatments. Certainty evidence was judged according to the GRADE framework., Results: Eight out of 10,826 studies fulfilled the inclusion/exclusion criteria, accounting for 2,610 randomized patients. Six studies included patients with episodic migraine and two with chronic migraine. Topiramate dose ranged from 50 to 200 mg/day, and all studies included a placebo arm. There was a high certainty that topiramate: 1) increased the proportion of patients who achieved a 50% responder rate in monthly migraine days, compared to placebo [relative risk: 1.61 (95% confidence interval (CI): 1.29-2.01); absolute risk difference: 168 more per 1,000 (95% CI: 80 to 278 more)]; 2) was associated with 0.99 (95% CI: 1.41-0.58) fewer migraine days than placebo; 3) and had a higher proportion of patients with adverse events leading to treatment discontinuation [absolute risk difference 80 patients more per 1,000 (95% CI: 20 to 140 more patients)]., Conclusions: There is high-quality evidence of the efficacy of topiramate in the prophylaxis of migraine, albeit its use poses a risk of adverse events that may lead to treatment discontinuation, with a negative effect on patient satisfaction and adherence to care., (© 2023. Springer-Verlag Italia S.r.l., part of Springer Nature.)
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- 2023
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40. Impact of susceptibility-induced distortion correction on perfusion imaging by pCASL with a segmented 3D GRASE readout.
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Domingos C, Fouto AR, Nunes RG, Ruiz-Tagle A, Esteves I, Silva NA, Vilela P, Gil-Gouveia R, and Figueiredo P
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- Humans, Female, Magnetic Resonance Angiography methods, Spin Labels, Perfusion Imaging, Cerebrovascular Circulation, Magnetic Resonance Imaging methods, Imaging, Three-Dimensional methods, Brain diagnostic imaging
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Purpose: The consensus for the clinical implementation of arterial spin labeling (ASL) perfusion imaging recommends a segmented 3D Gradient and Spin-Echo (GRASE) readout for optimal signal-to-noise-ratio (SNR). The correction of the associated susceptibility-induced geometric distortions has been shown to improve diagnostic precision, but its impact on ASL data has not been systematically assessed and it is not consistently part of pre-processing pipelines. Here, we investigate the effects of susceptibility-induced distortion correction on perfusion imaging by pseudo-continuous ASL (pCASL) with a segmented 3D GRASE readout., Methods: Data acquired from 28 women using pCASL with 3D GRASE at 3T was analyzed using three pre-processing options: without distortion correction, with distortion correction, and with spatial smoothing (without distortion correction) matched to control for blurring effects induced by distortion correction. Maps of temporal SNR (tSNR) and relative perfusion were analyzed in eight regions-of-interest (ROIs) across the brain., Results: Distortion correction significantly affected tSNR and relative perfusion across the brain. Increases in tSNR were like those produced by matched spatial smoothing in most ROIs, indicating that they were likely due to blurring effects. However, that was not the case in the frontal and temporal lobes, where we also found increased relative perfusion with distortion correction even compared with matched spatial smoothing. These effects were found in both controls and patients, with no interactions with the participant group., Conclusion: Correction of susceptibility-induced distortions significantly impacts ASL perfusion imaging using a segmented 3D GRASE readout, and this step should therefore be considered in ASL pre-processing pipelines. This is of special importance in clinical studies, reporting perfusion across ROIs defined on relatively undistorted images and when conducting group analyses requiring the alignment of images across different subjects., Competing Interests: Declaration of Competing Interest There is no conflict of interest to declare., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2023
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41. European Headache Federation (EHF) critical re-appraisal and meta-analysis of oral drugs in migraine prevention-part 2: flunarizine.
- Author
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Deligianni CI, Sacco S, Ekizoglu E, Uluduz D, Gil-Gouveia R, MaassenVanDenBrink A, Ornello R, Sanchez-Del-Rio M, Reuter U, Versijpt J, de Vries T, Hussain M, Zeraatkar D, and Lampl C
- Subjects
- Humans, Flunarizine therapeutic use, Headache, Research Design, Transcription Factors, Migraine Disorders drug therapy, Migraine Disorders prevention & control, Migraine with Aura
- Abstract
Objective: Novel disease-specific and mechanism-based treatments sharing good evidence of efficacy for migraine have been recently marketed. However, reimbursement by insurers depends on treatment failure with classic anti-migraine drugs. In this systematic review and meta-analysis, we aimed to identify and rate the evidence for efficacy of flunarizine, a repurposed, first- or second-line treatment for migraine prophylaxis., Methods: A systematic search in MEDLINE, Cochrane CENTRAL, and ClinicalTrials.gov was performed for trials of pharmacological treatment in migraine prophylaxis, following the Preferred Reporting Items for Systematic Reviews (PRISMA). Eligible trials for meta-analysis were randomized, placebo-controlled studies comparing flunarizine with placebo. Outcomes of interest according to the Outcome Set for preventive intervention trials in chronic and episodic migraine (COSMIG) were the proportion of patients reaching a 50% or more reduction in monthly migraine days, the change in monthly migraine days (MMDs), and Adverse Events (AEs) leading to discontinuation., Results: Five trials were eligible for narrative description and three for data synthesis and analysis. No studies reported the predefined outcomes, but one study assessed the 50% reduction in monthly migraine attacks with flunarizine as compared to placebo showing a benefit from flunarizine with a low or probably low risk of bias. We found that flunarizine may increase the proportion of patients who discontinue due to adverse events compared to placebo (risk difference: 0.02; 95% CI -0.03 to 0.06)., Conclusions: Published flunarizine trials predate the recommended endpoints for evaluating migraine prophylaxis drugs, hence the lack of an adequate assessment for these endpoints. Further, modern-day, large-scale studies would be valuable in re-evaluating the efficacy of flunarizine for the treatment of migraines, offering additional insights into its potential benefits., (© 2023. Springer-Verlag Italia S.r.l., part of Springer Nature.)
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- 2023
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42. The comparative effectiveness of migraine preventive drugs: a systematic review and network meta-analysis.
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Lampl C, MaassenVanDenBrink A, Deligianni CI, Gil-Gouveia R, Jassal T, Sanchez-Del-Rio M, Reuter U, Uluduz D, Versijpt J, Zeraatkar D, and Sacco S
- Subjects
- Adult, Humans, Topiramate adverse effects, Gabapentin therapeutic use, Calcitonin Gene-Related Peptide therapeutic use, Network Meta-Analysis, Amitriptyline therapeutic use, Antibodies, Monoclonal therapeutic use, Valproic Acid therapeutic use, Migraine Disorders drug therapy, Migraine Disorders prevention & control, Migraine Disorders chemically induced
- Abstract
Objective: While there are several trials that support the efficacy of various drugs for migraine prophylaxis against placebo, there is limited evidence addressing the comparative safety and efficacy of these drugs. We conducted a systematic review and network meta-analysis to facilitate comparison between drugs for migraine prophylaxis., Methods: We searched MEDLINE, EMBASE, CENTRAL, and clinicaltrials.gov from inception to August 13, 2022, for randomized trials of pharmacological treatments for migraine prophylaxis in adults. Reviewers worked independently and in duplicate to screen references, extract data, and assess risk of bias. We performed a frequentist random-effects network meta-analysis and rated the certainty (quality) of evidence as either high, moderate, low, or very low using the GRADE approach., Results: We identified 74 eligible trials, reporting on 32,990 patients. We found high certainty evidence that monoclonal antibodies acting on the calcitonin gene related peptide or its receptor (CGRP(r)mAbs), gepants, and topiramate increase the proportion of patients who experience a 50% or more reduction in monthly migraine days, compared to placebo. We found moderate certainty evidence that beta-blockers, valproate, and amitriptyline increase the proportion of patients who experience a 50% or more reduction in monthly migraine days, and low certainty evidence that gabapentin may not be different from placebo. We found high certainty evidence that, compared to placebo, valproate and amitriptyline lead to substantial adverse events leading to discontinuation, moderate certainty evidence that topiramate, beta-blockers, and gabapentin increase adverse events leading to discontinuation, and moderate to high certainty evidence that (CGRP(r)mAbs) and gepants do not increase adverse events., Conclusions: (CGRP(r)mAbs) have the best safety and efficacy profile of all drugs for migraine prophylaxis, followed closely by gepants., (© 2023. The Author(s).)
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- 2023
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43. European Headache Federation (EHF) critical re-appraisal and meta-analysis of oral drugs in migraine prevention-part 1: amitriptyline.
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Lampl C, Versijpt J, Amin FM, Deligianni CI, Gil-Gouveia R, Jassal T, MaassenVanDenBrink A, Ornello R, Paungarttner J, Sanchez-Del-Rio M, Reuter U, Uluduz D, de Vries T, Zeraatkar D, and Sacco S
- Subjects
- Adult, Humans, Headache, Transcription Factors therapeutic use, Amitriptyline adverse effects, Migraine Disorders prevention & control, Migraine Disorders drug therapy
- Abstract
Objective: The aim of this paper is to critically re-appraise the published trials assessing amitriptyline for migraine prophylaxis., Methods: We report our methods and results following the Preferred Reporting Items for Systematic Reviews (PRISMA), by searching MEDLINE, EMBASE, Cochrane CENTRAL, and ClinicalTrials.gov for randomized trials of pharmacologic treatments for migraine prophylaxis. We included randomized trials that compared amitriptyline with placebo for migraine prophylaxis in adults. Our outcomes of interest were informed by the Outcome Set for preventive intervention trials in chronic and episodic migraine (COSMIG) and include the proportion of patients who experience a 50% or more reduction in migraine days per month, migraine days per month, and adverse events leading to discontinuation. We assessed risk of bias by using a modified Cochrane RoB 2.0 tool and the certainty of evidence by using the GRADE approach., Results: Our search yielded 10.826 unique records, of which three trials (n = 622) were eligible for data synthesis and analysis. We found moderate certainty evidence that amitriptyline increases the proportion of patients who experience a 50% or more reduction in monthly migraine days, compared to placebo (relative risk: 1.60 (95% CI 1.17 to 2.19); absolute risk difference: 165 more per 1,000 (95% CI 47 more to 327 more). We found moderate certainty evidence that amitriptyline increases the proportion of patients who discontinue due to adverse events compared to placebo (risk difference: 0.05 (95% CI 0.01 to 0.10); absolute risk difference: 50 more per 1,000 (95% CI 10 more to 100 more)., Conclusions: Our meta-analysis showed that amitriptyline may have a prophylactic role in migraine patients, however these results are far from robust. This warrants further large-scale research to evaluate the role of amitriptyline in migraine prevention., (© 2023. The Author(s).)
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- 2023
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44. Cranial Autonomic Symptoms and Neck Pain in Differential Diagnosis of Migraine.
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Vicente BN, Oliveira R, Martins IP, and Gil-Gouveia R
- Abstract
Cranial autonomic symptoms and neck pain have been reported to be highly prevalent in migraine, although they are rarely considered in clinical evaluation. The aim of this review is to focus on the prevalence, pathophysiology, and clinical characteristics of these two symptoms, and their importance in the differential diagnosis between migraines and other headaches. The most common cranial autonomic symptoms are aural fullness, lacrimation, facial/forehead sweating, and conjunctival injection. Migraineurs experiencing cranial autonomic symptoms are more likely to have more severe, frequent, and longer attacks, as well as higher rates of photophobia, phonophobia, osmophobia, and allodynia. Cranial autonomic symptoms occur due to the activation of the trigeminal autonomic reflex, and the differential diagnosis with cluster headaches can be challenging. Neck pain can be part of the migraine prodromal symptoms or act as a trigger for a migraine attack. The prevalence of neck pain correlates with headache frequency and is associated with treatment resistance and greater disability. The convergence between upper cervical and trigeminal nociception via the trigeminal nucleus caudalis is the likely mechanism for neck pain in migraine. The recognition of cranial autonomic symptoms and neck pain as potential migraine features is important because they often contribute to the misdiagnosis of cervicogenic problems, tension-type headache, cluster headache, and rhinosinusitis in migraine patients, delaying appropriate attack and disease management.
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- 2023
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45. Current Evidence in Migraine Surgery-A Comment on a Systematic Review.
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Gil-Gouveia R and Parracho Costa J
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- Humans, Systematic Reviews as Topic, Migraine Disorders surgery
- Abstract
Competing Interests: Conflicts of interest and sources of funding: none declared.
- Published
- 2022
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46. European Headache Federation (EHF) consensus on the definition of effective treatment of a migraine attack and of triptan failure.
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Sacco S, Lampl C, Amin FM, Braschinsky M, Deligianni C, Uludüz D, Versijpt J, Ducros A, Gil-Gouveia R, Katsarava Z, Martelletti P, Ornello R, Raffaelli B, Boucherie DM, Pozo-Rosich P, Sanchez-Del-Rio M, Sinclair A, Maassen van den Brink A, and Reuter U
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- Consensus, Headache drug therapy, Humans, Serotonin 5-HT1 Receptor Agonists therapeutic use, Transcription Factors therapeutic use, Migraine Disorders diagnosis, Migraine Disorders drug therapy, Tryptamines pharmacology, Tryptamines therapeutic use
- Abstract
Background: Triptans are migraine-specific acute treatments. A well-accepted definition of triptan failure is needed in clinical practice and for research. The primary aim of the present Consensus was to provide a definition of triptan failure. To develop this definition, we deemed necessary to develop as first a consensus definition of effective treatment of an acute migraine attack and of triptan-responder., Main Body: The Consensus process included a preliminary literature review, a Delphi round and a subsequent open discussion. According to the Consensus Panel, effective treatment of a migraine attack is to be defined on patient well-being featured by a) improvement of headache, b) relief of non-pain symptoms and c) absence of adverse events. An attack is considered effectively treated if patient's well-being, as defined above, is restored within 2 hours and for at least 24 hours. An individual with migraine is considered as triptan-responder when the given triptan leads to effective acute attack treatment in at least three out of four migraine attacks. On the other hand, an individual with migraine is considered triptan non-responder in the presence of failure of a single triptan (not matching the definition of triptan-responder). The Consensus Panel defined an individual with migraine as triptan-resistant in the presence of failure of at least 2 triptans; triptan refractory, in the presence of failure to at least 3 triptans, including subcutaneous formulation; triptan ineligibile in the presence of an acknowledged contraindication to triptan use, as specified in the summary of product characteristics., Conclusions: The novel definitions can be useful in clinical practice for the assessment of acute attack treatments patients with migraine. They may be helpful in identifying people not responding to triptans and in need for novel acute migraine treatments. The definitions will also be of help in standardizing research on migraine acute care., (© 2022. The Author(s).)
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- 2022
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47. Gestational exposure to erenumab-The outcome of three pregnancies.
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Bonifácio GV, de Carvalho SC, Oliveira R, and Gil-Gouveia R
- Subjects
- Female, Humans, Infant, Newborn, Pregnancy, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal, Humanized adverse effects, Treatment Outcome, Calcitonin Gene-Related Peptide, Calcitonin Gene-Related Peptide Receptor Antagonists therapeutic use
- Abstract
Erenumab is a monoclonal antibody (mAb) approved for the preventive treatment of migraine. While preclinical studies on calcitonin gene-related peptide mAbs did not identify any reproductive toxicity, pregnant and breastfeeding women were excluded from the pivotal human studies, and therefore the safety of calcitonin gene-related peptide medications in this population must be studied. So far, postmarketing data of accidental exposures have not brought to light any specific toxicities. Three women treated with erenumab in our series conceived while exposed to the drug. All had previous successful pregnancies, were on erenumab for more than 6 months, and had ≥80% reduction in headache frequency. The one who stopped erenumab only 1 month before conceiving had a spontaneous abortion during the first trimester due to a gestational trophoblastic neoplasia and has since conceived with an uneventful gestation. The other two women stopped treatment during the first trimester, and both pregnancies went to term with no complications. All babies have shown normal development. No plausible explanation relates the mechanism of action of erenumab and the serious complication that occurred in one patient. Continuous follow-up and reporting of all exposures are encouraged to gather safety data on pregnant and nursing women and on the development of the newborns. So far, immediately stopping the drug is advised and may contribute to decreasing the potential risks., (© 2022 American Headache Society.)
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- 2022
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48. Use of Non-pharmacological Therapies in Individuals With Migraine Eligible for Treatment With Monoclonal Antibodies Targeting Calcitonin Gene-Related Peptide (CGRP)-Signaling: A Single-Center Cross-Sectional Observational Study.
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Rundblad L, Cullum CK, Sacco S, Gil-Gouveia R, Uludüz D, Do TP, and Amin FM
- Abstract
Introduction: Accessibility of treatment with monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) signaling pathway is impeded by regulatory restrictions. Affected individuals may seek out other services including non-pharmacological therapies. Thus, we found it timely to ascertain the use of non-pharmacological therapies in individuals with treatment-resistant migraine eligible for and naïve to treatment with CGRP-signaling targeting monoclonal antibodies., Methods: We conducted a single-center cross-sectional observational study of patients eligible for and naïve to treatment with monoclonal antibodies targeting CGRP or its receptor. We recorded demographical information (gender, age, educational level, employment status, and income), disease burden (frequency of headache days and migraine days), previous use of preventive pharmacological medications for migraine, and use of non-pharmacological therapies over the past 3 months including frequency of interventions, costs, and patient-reported assessment of efficacy on a 6-point scale (0: no efficacy, 5: best possible efficacy)., Results: We included 122 patients between 17 June 2019 and 6 January 2020; 101 (83%) were women and the mean age was 45.2 ± 13.3 years. One-third ( n = 41 [34%]) had used non-pharmacological therapy within the past 3 months. Among these participants, the median frequency of different interventions was 1 (IQR: 1-2), the median number of monthly visits was 2.3 (IQR: 1.3-4), mean and median monthly costs were 1,086 ± 1471, and 600 (IQR: 0-1200) DKK (1 EUR = ~7.5 DKK), respectively, and median patient-reported assessment of the efficacy of interventions was 2 (IQR: 0-3)., Conclusion: Even in a high-income country with freely accessible headache services and universal healthcare coverage, there was a non-negligible direct cost in parallel with low satisfaction for non-pharmacological therapies among patients at a tertiary headache center., Competing Interests: SS reports grants, personal fees and/or non-financial support from Allergan, Novartis, Teva, Eli Lilly, AstraZeneca, Abbott, Medscape, Pfizer, Bayer, Medtronic, Starmed, Bristol-Meyer-Squibb, Daiichi-Sankyo, Lundbeck, Uriach and Neurodiem Ology Medical Education. RG-G reports Honoraria for conferences, consulting or educational activities: Novartis, Allergan/ Abbvie, Teva, Lilly, Lundbeck, Tecnifar, Pfizer, FLOAT, CMBE. Research grants: Fundação para a Ciência e Tecnologia (project 29675, MigN2Treat, 02/SAICT/2017), Novartis-Sociedade Portuguesa de Cefaleias and Learning-Health, Luz Saúde (Research group LiON, Luz Innovation on Neurosciences). DU reports grants, personal fees and/or non-financial support from Allergan, Novartis, Teva, Eli Lilly. FA has received honoraria and personal fees from Teva, Lundbeck, Novartis, Eli Lilly for lecturing or participating in advisory boards. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Rundblad, Cullum, Sacco, Gil-Gouveia, Uludüz, Do and Amin.)
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- 2022
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49. European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention - 2022 update.
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Sacco S, Amin FM, Ashina M, Bendtsen L, Deligianni CI, Gil-Gouveia R, Katsarava Z, MaassenVanDenBrink A, Martelletti P, Mitsikostas DD, Ornello R, Reuter U, Sanchez-Del-Rio M, Sinclair AJ, Terwindt G, Uluduz D, Versijpt J, and Lampl C
- Subjects
- Antibodies, Monoclonal therapeutic use, Calcitonin Gene-Related Peptide Receptor Antagonists pharmacology, Calcitonin Gene-Related Peptide Receptor Antagonists therapeutic use, Headache drug therapy, Humans, Calcitonin Gene-Related Peptide metabolism, Migraine Disorders drug therapy, Migraine Disorders metabolism, Migraine Disorders prevention & control
- Abstract
Background: A previous European Headache Federation (EHF) guideline addressed the use of monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway to prevent migraine. Since then, randomized controlled trials (RCTs) and real-world evidence have expanded the evidence and knowledge for those treatments. Therefore, the EHF panel decided to provide an updated guideline on the use of those treatments., Methods: The guideline was developed following the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach. The working group identified relevant questions, performed a systematic review and an analysis of the literature, assessed the quality of the available evidence, and wrote recommendations. Where the GRADE approach was not applicable, expert opinion was provided., Results: We found moderate to high quality of evidence to recommend eptinezumab, erenumab, fremanezumab, and galcanezumab in individuals with episodic and chronic migraine. For several important clinical questions, we found not enough evidence to provide evidence-based recommendations and guidance relied on experts' opinion. Nevertheless, we provided updated suggestions regarding the long-term management of those treatments and their place with respect to the other migraine preventatives., Conclusion: Monoclonal antibodies targeting the CGRP pathway are recommended for migraine prevention as they are effective and safe also in the long-term., (© 2022. The Author(s).)
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- 2022
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50. Headaches and the use of personal protective equipment in the general population during the COVID-19 pandemic.
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Oliveira R, Plácido M, Pereira L, Machado S, Parreira E, and Gil-Gouveia R
- Subjects
- Adult, Female, Headache epidemiology, Humans, Male, Middle Aged, Pandemics prevention & control, Personal Protective Equipment, COVID-19, Migraine Disorders epidemiology, Migraine Disorders prevention & control
- Abstract
Introduction: Headaches associated with personal protective equipment were reported in health-care workers in previous epidemiological studies., Methods: National web-based survey advertised by the Portuguese Headache Society and National Headache and Migraine patient´s organization between September-December 2020 screening for personal protective equipment usage pattern, pre-existing and de novo headaches after the onset of the COVID-19 pandemic, and its relation to personal protective equipment use., Results: Of 5064 participants, 90.6% (4562/5034) were women, mean age was 37.2 ± 11 years. Most questions had a completion rate above 87% (non-completion rate ranging from 0-12.7%). Twenty percent were health-care professionals (993/5046). Surgical and cloth masks were the most common personal protective equipment type, whereas protective eyewear and FFP2/FFP3 masks were mostly used by health-care professionals. About 97% (1814/1870) of migraine and headache participants reported aggravation of pre-existing headaches with personal protective equipment use, and 56% (2476/4420) had de novo headaches. Participants with de novo headaches had a higher frequency of pre-existing migraine (1118/1226, 91.2% vs 1408/1600, 88%, P = .042), and wore personal protective equipment for longer periods of time (7 ± 2 h 42 vs 6 ± 2 h 54 min per day, P < .001). In multivariate analysis longer mean duration of personal protective equipment use (OR of 1.1, 95% CI 1-1.2) and previous migraine (OR of 1.2, 95% CI 1-1.4) were predictors of developing de novo headaches., Conclusions: Almost all participants with pre-existing headache reported worsening of their headaches, and more than half of the study population developed de novo headaches following personal protective equipment use. Duration of personal protective equipment usage and pre-existing migraine were the strongest predictors of de novo headaches.
- Published
- 2022
- Full Text
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