5 results on '"Violante, I. R."'
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2. Digitalized transcranial electrical stimulation: A consensus statement
- Author
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Brunoni, A. R., Ekhtiari, H., Antal, A., Auvichayapat, P., Baeken, C., Bensenor, I. M., Bikson, M., Boggio, P., Borroni, B., Brighina, F., Brunelin, J., Carvalho, S., Caumo, W., Ciechanski, P., Charvet, L., Clark, V. P., Cohen Kadosh, R., Cotelli, Maria, Datta, A., Deng, Z. -D., De Raedt, R., De Ridder, D., Fitzgerald, P. B., Floel, A., Frohlich, F., George, M. S., Ghobadi-Azbari, P., Goerigk, S., Hamilton, R. H., Jaberzadeh, S. J., Hoy, K., Kidgell, D. J., Zonoozi, A. K., Kirton, A., Laureys, S., Lavidor, M., Lee, K., Leite, J., Lisanby, S. H., Loo, C., Martin, D. M., Miniussi, C., Mondino, M., Monte-Silva, K., Morales-Quezada, L., Nitsche, M. A., Okano, A. H., Oliveira, C. S., Onarheim, B., Pacheco-Barrios, K., Padberg, F., Nakamura-Palacios, E. M., Palm, U., Paulus, W., Plewnia, C., Priori, A., Rajji, T. K., Razza, L. B., Rehn, E. M., Ruffini, G., Schellhorn, K., Zare-Bidoky, M., Simis, M., Skorupinski, P., Suen, P., Thibaut, A., Valiengo, L. C. L., Vanderhasselt, M. -A., Vanneste, S., Venkatasubramanian, G., Violante, I. R., Wexler, A., Woods, A. J., Fregni, F., Cotelli M., Brunoni, A. R., Ekhtiari, H., Antal, A., Auvichayapat, P., Baeken, C., Bensenor, I. M., Bikson, M., Boggio, P., Borroni, B., Brighina, F., Brunelin, J., Carvalho, S., Caumo, W., Ciechanski, P., Charvet, L., Clark, V. P., Cohen Kadosh, R., Cotelli, Maria, Datta, A., Deng, Z. -D., De Raedt, R., De Ridder, D., Fitzgerald, P. B., Floel, A., Frohlich, F., George, M. S., Ghobadi-Azbari, P., Goerigk, S., Hamilton, R. H., Jaberzadeh, S. J., Hoy, K., Kidgell, D. J., Zonoozi, A. K., Kirton, A., Laureys, S., Lavidor, M., Lee, K., Leite, J., Lisanby, S. H., Loo, C., Martin, D. M., Miniussi, C., Mondino, M., Monte-Silva, K., Morales-Quezada, L., Nitsche, M. A., Okano, A. H., Oliveira, C. S., Onarheim, B., Pacheco-Barrios, K., Padberg, F., Nakamura-Palacios, E. M., Palm, U., Paulus, W., Plewnia, C., Priori, A., Rajji, T. K., Razza, L. B., Rehn, E. M., Ruffini, G., Schellhorn, K., Zare-Bidoky, M., Simis, M., Skorupinski, P., Suen, P., Thibaut, A., Valiengo, L. C. L., Vanderhasselt, M. -A., Vanneste, S., Venkatasubramanian, G., Violante, I. R., Wexler, A., Woods, A. J., Fregni, F., and Cotelli M.
- Abstract
Objective: Although relatively costly and non-scalable, non-invasive neuromodulation interventions are treatment alternatives for neuropsychiatric disorders. The recent developments of highly-deployable transcranial electric stimulation (tES) systems, combined with mobile-Health technologies, could be incorporated in digital trials to overcome methodological barriers and increase equity of access. The study aims are to discuss the implementation of tES digital trials by performing a systematic scoping review and strategic process mapping, evaluate methodological aspects of tES digital trial designs, and provide Delphi-based recommendations for implementing digital trials using tES. Methods: We convened 61 highly-productive specialists and contacted 8 tES companies to assess 71 issues related to tES digitalization readiness, and processes, barriers, advantages, and opportunities for implementing tES digital trials. Delphi-based recommendations (>60% agreement) were provided. Results: The main strengths/opportunities of tES were: (i) non-pharmacological nature (92% of agreement), safety of these techniques (80%), affordability (88%), and potential scalability (78%). As for weaknesses/threats, we listed insufficient supervision (76%) and unclear regulatory status (69%). Many issues related to methodological biases did not reach consensus. Device appraisal showed moderate digitalization readiness, with high safety and potential for trial implementation, but low connectivity. Conclusions: Panelists recognized the potential of tES for scalability, generalizability, and leverage of digital trials processes; with no consensus about aspects regarding methodological biases. Significance: We further propose and discuss a conceptual framework for exploiting shared aspects between mobile-Health tES technologies with digital trials methodology to drive future efforts for digitizing tES trials.
- Published
- 2022
3. A questionnaire to collect unintended effects of transcranial magnetic stimulation:A consensus based approach
- Author
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Giustiniani, A., Vallesi, A., Oliveri, M., Tarantino, V., Ambrosini, E., Bortoletto, M., Masina, F., Busan, P., Siebner, H. R., Fadiga, L., Koch, G., Leocani, L., Lefaucheur, J. P., Rotenberg, A., Zangen, A., Violante, I. R., Moliadze, V., Gamboa, O. L., Ugawa, Y., Pascual-Leone, A., Ziemann, U., Miniussi, C., Burgio, F., Giustiniani, A., Vallesi, A., Oliveri, M., Tarantino, V., Ambrosini, E., Bortoletto, M., Masina, F., Busan, P., Siebner, H. R., Fadiga, L., Koch, G., Leocani, L., Lefaucheur, J. P., Rotenberg, A., Zangen, A., Violante, I. R., Moliadze, V., Gamboa, O. L., Ugawa, Y., Pascual-Leone, A., Ziemann, U., Miniussi, C., and Burgio, F.
- Abstract
Transcranial magnetic stimulation (TMS) has been widely used in both clinical and research practice. However, TMS might induce unintended sensations and undesired effects as well as serious adverse effects. To date, no shared forms are available to report such unintended effects. This study aimed at developing a questionnaire enabling reporting of TMS unintended effects. A Delphi procedure was applied which allowed consensus among TMS experts. A steering committee nominated a number of experts to be involved in the Delphi procedure. Three rounds were conducted before reaching a consensus. Afterwards, the questionnaire was publicized on the International Federation of Clinical Neurophysiology website to collect further suggestions by the wider scientific community. A last Delphi round was then conducted to obtain consensus on the suggestions collected during the publicization and integrate them in the questionnaire. The procedure resulted in a questionnaire, that is the TMSens_Q, applicable in clinical and research settings. Routine use of the structured TMS questionnaire and standard reporting of unintended TMS effects will help to monitor the safety of TMS, particularly when applying new protocols. It will also improve the quality of data collection as well as the interpretation of experimental findings.
- Published
- 2022
4. A checklist for assessing the methodological quality of concurrent tES-fMRI studies (ContES checklist): A consensus study and statement
- Author
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Ekhtiari, Hamed, Ghobadi-Azbari, Peyman, Thielscher, Axel, Antal, Andrea, Li, Lucia M., Shereen, A. Duke, Cabral-Calderin, Yuranny, Keeser, Daniel, Bergmann, Til Ole, Jamil, Asif, Violante, Ines R., Almeida, Jorge, Meinzer, Marcus, Siebner, Hartwig R., Woods, Adam J., Stagg, Charlotte J., Abend, Rany, Antonenko, Daria, Auer, Tibor, Bächinger, Marc, Baeken, Chris, Barron, Helen C., Chase, Henry W., Crinion, Jenny, Datta, Abhishek, Davis, Matthew H., Ebrahimi, Mohsen, Esmaeilpour, Zeinab, Falcone, Brian, Fiori, Valentina, Ghodratitoostani, Iman, Gilam, Gadi, Grabner, Roland H., Greenspan, Joel D., Groen, Georg, Hartwigsen, Gesa, Hauser, Tobias U., Herrmann, Christoph S., Juan, Chi-Hung, Krekelberg, Bart, Lefebvre, Stephanie, Liew, Sook-Lei, Madsen, Kristoffer H., Mahdavifar-Khayati, Rasoul, Malmir, Nastaran, Marangolo, Paola, Martin, Andrew K., Meeker, Timothy J., Ardabili, Hossein Mohaddes, Moisa, Marius, Momi, Davide, Mulyana, Beni, Opitz, Alexander, Orlov, Natasza, Ragert, Patrick, Ruff, Christian C., Ruffini, Giulio, Ruttorf, Michaela, Sangchooli, Arshiya, Schellhorn, Klaus, Schlaug, Gottfried, Sehm, Bernhard, Soleimani, Ghazaleh, Tavakoli, Hosna, Thompson, Benjamin, Timmann, Dagmar, Tsuchiyagaito, Aki, Ulrich, Martin, Vosskuhl, Johannes, Weinrich, Christiane A., Zare-Bidoky, Mehran, Zhang, Xiaochu, Zoefel, Benedikt, Nitsche, Michael A., Bikson, Marom, Timmann-Braun, Dagmar, Brain, Body and Cognition, Clinical sciences, Neuroprotection & Neuromodulation, Psychiatry, Ekhtiari, H., Ghobadi-Azbari, P., Thielscher, A., Antal, A., Li, L. M., Shereen, A. D., Cabral-Calderin, Y., Keeser, D., Bergmann, T. O., Jamil, A., Violante, I. R., Almeida, J., Meinzer, M., Siebner, H. R., Woods, A. J., Stagg, C. J., Abend, R., Antonenko, D., Auer, T., Bachinger, M., Baeken, C., Barron, H. C., Chase, H. W., Crinion, J., Datta, A., Davis, M. H., Ebrahimi, M., Esmaeilpour, Z., Falcone, B., Fiori, V., Ghodratitoostani, I., Gilam, G., Grabner, R. H., Greenspan, J. D., Groen, G., Hartwigsen, G., Hauser, T. U., Herrmann, C. S., Juan, C. -H., Krekelberg, B., Lefebvre, S., Liew, S. -L., Madsen, K. H., Mahdavifar-Khayati, R., Malmir, N., Marangolo, P., Martin, A. K., Meeker, T. J., Ardabili, H. M., Moisa, M., Momi, D., Mulyana, B., Opitz, A., Orlov, N., Ragert, P., Ruff, C. C., Ruffini, G., Ruttorf, M., Sangchooli, A., Schellhorn, K., Schlaug, G., Sehm, B., Soleimani, G., Tavakoli, H., Thompson, B., Timmann, D., Tsuchiyagaito, A., Ulrich, M., Vosskuhl, J., Weinrich, C. A., Zare-Bidoky, M., Zhang, X., Zoefel, B., Nitsche, M. A., and Bikson, M.
- Subjects
Consensus ,Medizin ,Reproducibility of Results ,BF ,Transcranial Direct Current Stimulation ,Magnetic Resonance Imaging ,General Biochemistry, Genetics and Molecular Biology ,Article ,Checklist ,Psychiatry and Mental health ,study ,Methodological quality ,ContES checklist ,tES-fMRI studies - Abstract
BACKGROUND: Low intensity transcranial electrical stimulation (tES), including alternating or direct current stimulation (tACS or tDCS), applies weak electrical stimulation to modulate the activity of brain circuits. Integration of tES with concurrent functional magnetic resonance imaging (fMRI) allows for the mapping of neural activity during neuromodulation, supporting causal studies of both brain function and tES effects. Methodological aspects of tES-fMRI studies underpin the results, and reporting them in appropriate detail is required for reproducibility and interpretability. Despite the growing number of published reports, there are no consensus-based checklists for disclosing methodological details of concurrent tES-fMRI studies. OBJECTIVE: To develop a consensus-based checklist of reporting standards for concurrent tES-fMRI studies to support methodological rigor, transparency, and reproducibility (ContES Checklist). METHODS: A two-phase Delphi consensus process was conducted by a steering committee (SC) of 13 members and 49 expert panelists (EP) through the International Network of the tES-fMRI (INTF) Consortium. The process began with a circulation of a preliminary checklist of essential items and additional recommendations, developed by the SC based on a systematic review of 57 concurrent tES-fMRI studies. Contributors were then invited to suggest revisions or additions to the initial checklist. After the revision phase, contributors rated the importance of the 17 essential items and 42 additional recommendations in the final checklist. The state of methodological transparency within the 57 reviewed concurrent tES-fMRI studies was then assessed using the checklist. RESULTS: Experts refined the checklist through the revision and rating phases, leading to a checklist with three categories of essential items and additional recommendations: (1) technological factors, (2) safety and noise tests, and (3) methodological factors. The level of reporting of checklist items varied among the 57 concurrent tES-fMRI papers, ranging from 24% to 76%. On average, 53% of checklist items were reported in a given article. CONCLUSIONS: Use of the ContES checklist is expected to enhance the methodological reporting quality of future concurrent tES-fMRI studies, and increase methodological transparency and reproducibility.
- Published
- 2022
5. A questionnaire to collect unintended effects of transcranial magnetic stimulation: A consensus based approach.
- Author
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Giustiniani A, Vallesi A, Oliveri M, Tarantino V, Ambrosini E, Bortoletto M, Masina F, Busan P, Siebner HR, Fadiga L, Koch G, Leocani L, Lefaucheur JP, Rotenberg A, Zangen A, Violante IR, Moliadze V, Gamboa OL, Ugawa Y, Pascual-Leone A, Ziemann U, Miniussi C, and Burgio F
- Subjects
- Consensus, Humans, Surveys and Questionnaires, Transcranial Magnetic Stimulation adverse effects, Transcranial Magnetic Stimulation methods
- Abstract
Transcranial magnetic stimulation (TMS) has been widely used in both clinical and research practice. However, TMS might induce unintended sensations and undesired effects as well as serious adverse effects. To date, no shared forms are available to report such unintended effects. This study aimed at developing a questionnaire enabling reporting of TMS unintended effects. A Delphi procedure was applied which allowed consensus among TMS experts. A steering committee nominated a number of experts to be involved in the Delphi procedure. Three rounds were conducted before reaching a consensus. Afterwards, the questionnaire was publicized on the International Federation of Clinical Neurophysiology website to collect further suggestions by the wider scientific community. A last Delphi round was then conducted to obtain consensus on the suggestions collected during the publicization and integrate them in the questionnaire. The procedure resulted in a questionnaire, that is the TMSens_Q, applicable in clinical and research settings. Routine use of the structured TMS questionnaire and standard reporting of unintended TMS effects will help to monitor the safety of TMS, particularly when applying new protocols. It will also improve the quality of data collection as well as the interpretation of experimental findings., 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 © 2022 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.)
- Published
- 2022
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