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1. The consequences of the new European reclassification of non-invasive brain stimulation devices and the medical device regulations pose an existential threat to research and treatment: An invited opinion paper

Author

Antal, A, Ganho-Avila, A, Assecondi, S, Barbour, T, Bjekic, J, Blumberger, D, Bolognini, N, Brunelin, J, Chanes, L, Dale, M, Dubbioso, R, D'Urso, G, Filipcic, I, Filipovic, S, Hirnstein, M, Konings, F, Langguth, B, Leocani, L, Sorkhabi, M, Mulder, M, Nikander, M, Nowak, R, Oliviero, A, Onarheim, B, O'Shea, J, Pallanti, S, Rachid, F, Rajao-Saraiva, J, Rossi, S, Sack, A, Sauvaget, A, van der Scheer, R, Schellhorn, K, Soria-Frisch, A, Szekely, D, Tankisi, H, C, J, Tendolkar, I, Uusitalo, S, Baeken, C, Antal A., Ganho-Avila A., Assecondi S., Barbour T., Bjekic J., Blumberger D. M., Bolognini N., Brunelin J., Chanes L., Dale M., Dubbioso R., D'Urso G., Filipcic I., Filipovic S. R., Hirnstein M., Konings F., Langguth B., Leocani L., Sorkhabi M. M., Mulder M., Nikander M., Nowak R., Oliviero A., Onarheim B., O'Shea J., Pallanti S., Rachid F., Rajao-Saraiva J., Rossi S., Sack A. T., Sauvaget A., van der Scheer R., Schellhorn K., Soria-Frisch A., Szekely D., Tankisi H., CJ. Taylor P., Tendolkar I., Uusitalo S., Baeken C., Antal, A, Ganho-Avila, A, Assecondi, S, Barbour, T, Bjekic, J, Blumberger, D, Bolognini, N, Brunelin, J, Chanes, L, Dale, M, Dubbioso, R, D'Urso, G, Filipcic, I, Filipovic, S, Hirnstein, M, Konings, F, Langguth, B, Leocani, L, Sorkhabi, M, Mulder, M, Nikander, M, Nowak, R, Oliviero, A, Onarheim, B, O'Shea, J, Pallanti, S, Rachid, F, Rajao-Saraiva, J, Rossi, S, Sack, A, Sauvaget, A, van der Scheer, R, Schellhorn, K, Soria-Frisch, A, Szekely, D, Tankisi, H, C, J, Tendolkar, I, Uusitalo, S, Baeken, C, Antal A., Ganho-Avila A., Assecondi S., Barbour T., Bjekic J., Blumberger D. M., Bolognini N., Brunelin J., Chanes L., Dale M., Dubbioso R., D'Urso G., Filipcic I., Filipovic S. R., Hirnstein M., Konings F., Langguth B., Leocani L., Sorkhabi M. M., Mulder M., Nikander M., Nowak R., Oliviero A., Onarheim B., O'Shea J., Pallanti S., Rachid F., Rajao-Saraiva J., Rossi S., Sack A. T., Sauvaget A., van der Scheer R., Schellhorn K., Soria-Frisch A., Szekely D., Tankisi H., CJ. Taylor P., Tendolkar I., Uusitalo S., and Baeken C.

Abstract

A significant amount of European basic and clinical neuroscience research includes the use of transcranial magnetic stimulation (TMS) and low intensity transcranial electrical stimulation (tES), mainly transcranial direct current stimulation (tDCS). Two recent changes in the EU regulations, the introduction of the Medical Device Regulation (MDR) (2017/745) and the Annex XVI have caused significant problems and confusions in the brain stimulation field. The negative consequences of the MDR for non-invasive brain stimulation (NIBS) have been largely overlooked and until today, have not been consequently addressed by National Competent Authorities, local ethical committees, politicians and by the scientific communities. In addition, a rushed bureaucratic decision led to seemingly wrong classification of NIBS products without an intended medical purpose into the same risk group III as invasive stimulators. Overregulation is detrimental for any research and for future developments, therefore researchers, clinicians, industry, patient representatives and an ethicist were invited to contribute to this document with the aim of starting a constructive dialogue and enacting positive changes in the regulatory environment.

Published
2024

2. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines

Author

Antal, A., Alekseichuk, I., Bikson, M., Brockmöller, J., Brunoni, A.R., Chen, R., Cohen, L.G., Dowthwaite, G., Ellrich, J., Flöel, A., Fregni, F., George, M.S., Hamilton, R., Haueisen, J., Herrmann, C.S., Hummel, F.C., Lefaucheur, J.P., Liebetanz, D., Loo, C.K., McCaig, C.D., Miniussi, C., Miranda, P.C., Moliadze, V., Nitsche, M.A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, P.M., Rothwell, J., Rueger, M.A., Ruffini, G., Schellhorn, K., Siebner, H.R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M., and Paulus, W.

Published
2017
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3. Digitalized transcranial electrical stimulation: A consensus statement

Author

Brunoni, AR, Ekhtiari, H, Antal, A, Auvichayapat, P, Baeken, C, Benseñor, IM, Bikson, M, Boggio, P, Borroni, B, Brighina, F, Brunelin, J, Carvalho, S, Caumo, W, Ciechanski, P, Charvet, L, Clark, VP, Cohen Kadosh, R, Cotelli, M, Datta, A, Deng, ZD, De Raedt, R, De Ridder, D, Fitzgerald, PB, Floel, A, Frohlich, F, George, MS, Ghobadi-Azbari, P, Goerigk, S, Hamilton, RH, Jaberzadeh, SJ, Hoy, K, Kidgell, DJ, Zonoozi, AK, Kirton, A, Laureys, S, Lavidor, M, Lee, K, Leite, J, Lisanby, SH, Loo, C ; https://orcid.org/0000-0003-3267-0554, Martin, DM ; https://orcid.org/0000-0002-8452-0390, Miniussi, C, Mondino, M, Monte-Silva, K, Morales-Quezada, L, Nitsche, MA, Okano, AH, Oliveira, CS, Onarheim, B, Pacheco-Barrios, K, Padberg, F, Nakamura-Palacios, EM, Palm, U, Paulus, W, Plewnia, C, Priori, A, Rajji, TK, Razza, LB, Rehn, EM, Ruffini, G, Schellhorn, K, Zare-Bidoky, M, Simis, M, Skorupinski, P, Suen, P, Thibaut, A, Valiengo, LCL, Vanderhasselt, MA, Vanneste, S, Venkatasubramanian, G, Violante, IR, Wexler, A, Woods, AJ, Fregni, F, Brunoni, AR, Ekhtiari, H, Antal, A, Auvichayapat, P, Baeken, C, Benseñor, IM, Bikson, M, Boggio, P, Borroni, B, Brighina, F, Brunelin, J, Carvalho, S, Caumo, W, Ciechanski, P, Charvet, L, Clark, VP, Cohen Kadosh, R, Cotelli, M, Datta, A, Deng, ZD, De Raedt, R, De Ridder, D, Fitzgerald, PB, Floel, A, Frohlich, F, George, MS, Ghobadi-Azbari, P, Goerigk, S, Hamilton, RH, Jaberzadeh, SJ, Hoy, K, Kidgell, DJ, Zonoozi, AK, Kirton, A, Laureys, S, Lavidor, M, Lee, K, Leite, J, Lisanby, SH, Loo, C ; https://orcid.org/0000-0003-3267-0554, Martin, DM ; https://orcid.org/0000-0002-8452-0390, Miniussi, C, Mondino, M, Monte-Silva, K, Morales-Quezada, L, Nitsche, MA, Okano, AH, Oliveira, CS, Onarheim, B, Pacheco-Barrios, K, Padberg, F, Nakamura-Palacios, EM, Palm, U, Paulus, W, Plewnia, C, Priori, A, Rajji, TK, Razza, LB, Rehn, EM, Ruffini, G, Schellhorn, K, Zare-Bidoky, M, Simis, M, Skorupinski, P, Suen, P, Thibaut, A, Valiengo, LCL, Vanderhasselt, MA, Vanneste, S, Venkatasubramanian, G, Violante, IR, Wexler, A, Woods, AJ, and Fregni, F

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

4. Digitalized transcranial electrical stimulation: A consensus statement

Author

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

11. Portable qEEG and HD-tCS Device for Point-of-Injury Traumatic Brain Injury Diagnostics

Author

Strisland F, Vedum J, Anders Erik Liverud, Dalgard S, Brødreskift T, Albert B, Noyvirt A, Setchi R, Vene K, Herranen H, Kirs M, Antal A, Schellhorn K, Sjaaheim H, Laboratoire SYstèmes et Matériaux pour la MEcatronique (SYMME), Université Savoie Mont Blanc (USMB [Université de Savoie] [Université de Chambéry]), Department of Theoretical Physics, Budapest University of Technology and Economics [Budapest] (BME), Symme, Univ. Savoie Mont Blanc, Blobel, B., and Goossen, W.

Subjects
[PHYS]Physics [physics], Diagnosis, Traumatic Brain Injury (TBI), Electroencephalography (EEG), Trans-Cranial Current Stimulation (tCS), TS, ComputingMilieux_MISCELLANEOUS, Portable Medical System, [PHYS] Physics [physics]
Abstract

Mild Traumatic Brain Injury (mTBI) can cause prolonged or permanent\ud injuries if left undetected and ignored. It is therefore of great interest to lower the\ud threshold for diagnosis of individuals with mTBI injury. We report on the\ud development of a prototype of a portable quantified EEG system intended for inthe-field\ud mTBI diagnostics. The 32-electrode system is fully battery driven, is\ud interfaced with a control unit being part of a telemedicine care system. All electrodes\ud are individually configurable sot that they can be used for wet or dry qEEG\ud electrodes. All electrodes can also be individually configured to allow Trans-Cranial\ud Current Stimulation (tCS) sessions in DC, AC or other current supply modalities.\ud The system has been functionality tested in end-to-end configurations where all\ud control and measurement signals are forwarded between the head device on one side\ud and the user interface and telemedicine system on the other. Tests confirm that the\ud device can acquire and forward EEG data from 32 channels in parallel at target\ud sensitivities up to 1 kHZ sampling frequencies. Tests further confirm that all\ud electrodes can be individually configured for DC or any alternating current\ud waveform up to 1 kHz. Additional device clinical evaluation is planned.

Published
2017

12. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines

Author

Antal, A., Alekseichuk, I., Bikson, M., Brockmöller, J., Brunoni, A.R., Chen, R., Cohen, L.G., Dowthwaite, G., Ellrich, J., Flöel, A., Fregni, F., George, M.S., Hamilton, R., Haueisen, J., Herrmann, C.S., Lefaucheur, J.P., Liebetanz, D., Loo, C.K., McCaig, C.D., Miniussi, C., Miranda, P.C., Moliadze, V., Nitsche, M.A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, P.M., Rothwell, J., Rueger, M.A., Ruffini, G., Schellhorn, K., Siebner, H.R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M., Paulus, W., Hummel, Friedhelm Christoph, Antal, A., Alekseichuk, I., Bikson, M., Brockmöller, J., Brunoni, A.R., Chen, R., Cohen, L.G., Dowthwaite, G., Ellrich, J., Flöel, A., Fregni, F., George, M.S., Hamilton, R., Haueisen, J., Herrmann, C.S., Lefaucheur, J.P., Liebetanz, D., Loo, C.K., McCaig, C.D., Miniussi, C., Miranda, P.C., Moliadze, V., Nitsche, M.A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, P.M., Rothwell, J., Rueger, M.A., Ruffini, G., Schellhorn, K., Siebner, H.R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M., Paulus, W., and Hummel, Friedhelm Christoph

Abstract

Low intensity transcranial electrical stimulation (TES) in humans, encompassing transcranial direct current (tDCS), transcutaneous spinal Direct Current Stimulation (tsDCS), transcranial alternating current (tACS), and transcranial random noise (tRNS) stimulation or their combinations, appears to be safe. No serious adverse events (SAEs) have been reported so far in over 18,000 sessions administered to healthy subjects, neurological and psychiatric patients, as summarized here. Moderate adverse events (AEs), as defined by the necessity to intervene, are rare, and include skin burns with tDCS due to suboptimal electrode-skin contact. Very rarely mania or hypomania was induced in patients with depression (11 documented cases), yet a causal relationship is difficult to prove because of the low incidence rate and limited numbers of subjects in controlled trials. Mild AEs (MAEs) include headache and fatigue following stimulation as well as prickling and burning sensations occurring during tDCS at peak-to-baseline intensities of 1-2mA and during tACS at higher peak-to-peak intensities above 2mA. The prevalence of published AEs is different in studies specifically assessing AEs vs. those not assessing them, being higher in the former. AEs are frequently reported by individuals receiving placebo stimulation. The profile of AEs in terms of frequency, magnitude and type is comparable in healthy and clinical populations, and this is also the case for more vulnerable populations, such as children, elderly persons, or pregnant women. Combined interventions (e.g., co-application of drugs, electrophysiological measurements, neuroimaging) were not associated with further safety issues. Safety is established for low-intensity 'conventional' TES defined as <4mA, up to 60min duration per day. Animal studies and modeling evidence indicate that brain injury could occur at predicted current densities in the brain of 6.3-13A/m2 that are over an order of magnitude above those produced by t

Published
2018
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13. Verstehende Methoden

Author

Haltern, U., Wittkämper, G. W., Behrens, H., Schellhorn, K. M., Bellers, Jürgen, editor, and Woyke, Wichard, editor

Published
1989
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14. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines

Author

Antal, A, Alekseichuk, I, Bikson, M, Brockmöller, J, Brunoni, AR, Chen, R, Cohen, LG, Dowthwaite, G, Ellrich, J, Flöel, A, Fregni, F, George, MS, Hamilton, R, Haueisen, J, Herrmann, CS, Hummel, FC, Lefaucheur, JP, Liebetanz, D, Loo, CK ; https://orcid.org/0000-0003-3267-0554, McCaig, CD, Miniussi, C, Miranda, PC, Moliadze, V, Nitsche, MA, Nowak, R, Padberg, F, Pascual-Leone, A, Poppendieck, W, Priori, A, Rossi, S, Rossini, PM, Rothwell, J, Rueger, MA, Ruffini, G, Schellhorn, K, Siebner, HR, Ugawa, Y, Wexler, A, Ziemann, U, Hallett, M, Paulus, W, Antal, A, Alekseichuk, I, Bikson, M, Brockmöller, J, Brunoni, AR, Chen, R, Cohen, LG, Dowthwaite, G, Ellrich, J, Flöel, A, Fregni, F, George, MS, Hamilton, R, Haueisen, J, Herrmann, CS, Hummel, FC, Lefaucheur, JP, Liebetanz, D, Loo, CK ; https://orcid.org/0000-0003-3267-0554, McCaig, CD, Miniussi, C, Miranda, PC, Moliadze, V, Nitsche, MA, Nowak, R, Padberg, F, Pascual-Leone, A, Poppendieck, W, Priori, A, Rossi, S, Rossini, PM, Rothwell, J, Rueger, MA, Ruffini, G, Schellhorn, K, Siebner, HR, Ugawa, Y, Wexler, A, Ziemann, U, Hallett, M, and Paulus, W

Abstract

Low intensity transcranial electrical stimulation (TES) in humans, encompassing transcranial direct current (tDCS), transcutaneous spinal Direct Current Stimulation (tsDCS), transcranial alternating current (tACS), and transcranial random noise (tRNS) stimulation or their combinations, appears to be safe. No serious adverse events (SAEs) have been reported so far in over 18,000 sessions administered to healthy subjects, neurological and psychiatric patients, as summarized here. Moderate adverse events (AEs), as defined by the necessity to intervene, are rare, and include skin burns with tDCS due to suboptimal electrode-skin contact. Very rarely mania or hypomania was induced in patients with depression (11 documented cases), yet a causal relationship is difficult to prove because of the low incidence rate and limited numbers of subjects in controlled trials. Mild AEs (MAEs) include headache and fatigue following stimulation as well as prickling and burning sensations occurring during tDCS at peak-to-baseline intensities of 1–2 mA and during tACS at higher peak-to-peak intensities above 2 mA. The prevalence of published AEs is different in studies specifically assessing AEs vs. those not assessing them, being higher in the former. AEs are frequently reported by individuals receiving placebo stimulation. The profile of AEs in terms of frequency, magnitude and type is comparable in healthy and clinical populations, and this is also the case for more vulnerable populations, such as children, elderly persons, or pregnant women. Combined interventions (e.g., co-application of drugs, electrophysiological measurements, neuroimaging) were not associated with further safety issues. Safety is established for low-intensity ‘conventional’ TES defined as <4 mA, up to 60 min duration per day. Animal studies and modeling evidence indicate that brain injury could occur at predicted current densities in the brain of 6.3–13 A/m2 that are over an order of magnitude above those produced

Published
2017

15. Low intensity transcranial electric stimulation:Safety, ethical, legal regulatory and application guidelines

Author

Antal, A., Alekseichuk, I., Bikson, M., Brockmöller, J., Brunoni, A. R., Chen, R., Cohen, L. G., Dowthwaite, G., Ellrich, J., Flöel, A., Fregni, F., George, M. S., Hamilton, R., Haueisen, J., Herrmann, C. S., Hummel, F. C., Lefaucheur, J. P., Liebetanz, D., Loo, C. K., McCaig, C. D., Miniussi, C., Miranda, P. C., Moliadze, V., Nitsche, M. A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, P. M., Rothwell, J., Rueger, M. A., Ruffini, G., Schellhorn, K., Siebner, H. R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M., Paulus, W., Antal, A., Alekseichuk, I., Bikson, M., Brockmöller, J., Brunoni, A. R., Chen, R., Cohen, L. G., Dowthwaite, G., Ellrich, J., Flöel, A., Fregni, F., George, M. S., Hamilton, R., Haueisen, J., Herrmann, C. S., Hummel, F. C., Lefaucheur, J. P., Liebetanz, D., Loo, C. K., McCaig, C. D., Miniussi, C., Miranda, P. C., Moliadze, V., Nitsche, M. A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, P. M., Rothwell, J., Rueger, M. A., Ruffini, G., Schellhorn, K., Siebner, H. R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M., and Paulus, W.

Abstract

Low intensity transcranial electrical stimulation (TES) in humans, encompassing transcranial direct current (tDCS), transcutaneous spinal Direct Current Stimulation (tsDCS), transcranial alternating current (tACS), and transcranial random noise (tRNS) stimulation or their combinations, appears to be safe. No serious adverse events (SAEs) have been reported so far in over 18,000 sessions administered to healthy subjects, neurological and psychiatric patients, as summarized here. Moderate adverse events (AEs), as defined by the necessity to intervene, are rare, and include skin burns with tDCS due to suboptimal electrode-skin contact. Very rarely mania or hypomania was induced in patients with depression (11 documented cases), yet a causal relationship is difficult to prove because of the low incidence rate and limited numbers of subjects in controlled trials. Mild AEs (MAEs) include headache and fatigue following stimulation as well as prickling and burning sensations occurring during tDCS at peak-to-baseline intensities of 1–2 mA and during tACS at higher peak-to-peak intensities above 2 mA. The prevalence of published AEs is different in studies specifically assessing AEs vs. those not assessing them, being higher in the former. AEs are frequently reported by individuals receiving placebo stimulation. The profile of AEs in terms of frequency, magnitude and type is comparable in healthy and clinical populations, and this is also the case for more vulnerable populations, such as children, elderly persons, or pregnant women. Combined interventions (e.g., co-application of drugs, electrophysiological measurements, neuroimaging) were not associated with further safety issues. Safety is established for low-intensity ‘conventional’ TES defined as <4 mA, up to 60 min duration per day. Animal studies and modeling evidence indicate that brain injury could occur at predicted current densities in the brain of 6.3–13 A/m2 that are over an order of magnitude abo

Published
2017

16. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines

Author

Berthoin Antal, Ariane, Alekseichuk, I., Bikson, M., Brockmöller, J., Brunoni, A. R., Chen, R., Cohen, L. G., Dowthwaite, G., Ellrich, J., Flöel, A., Fregni, F., George, M. S., Hamilton, R., Haueisen, J., Herrmann, C. S., Hummel, F. C., Lefaucheur, J. P., Liebetanz, D., Loo, C. K., Mccaig, C. D., Miniussi, C., Miranda, P. C., Moliadze, V., Nitsche, M. A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, Paolo Maria, Rothwell, J., Rueger, M. A., Ruffini, G., Schellhorn, K., Siebner, H. R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M., Paulus, W., Berthoin Antal, A., Rossini, P. M. (ORCID:0000-0003-2665-534X), Berthoin Antal, Ariane, Alekseichuk, I., Bikson, M., Brockmöller, J., Brunoni, A. R., Chen, R., Cohen, L. G., Dowthwaite, G., Ellrich, J., Flöel, A., Fregni, F., George, M. S., Hamilton, R., Haueisen, J., Herrmann, C. S., Hummel, F. C., Lefaucheur, J. P., Liebetanz, D., Loo, C. K., Mccaig, C. D., Miniussi, C., Miranda, P. C., Moliadze, V., Nitsche, M. A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, Paolo Maria, Rothwell, J., Rueger, M. A., Ruffini, G., Schellhorn, K., Siebner, H. R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M., Paulus, W., Berthoin Antal, A., and Rossini, P. M. (ORCID:0000-0003-2665-534X)

Abstract

Low intensity transcranial electrical stimulation (TES) in humans, encompassing transcranial direct current (tDCS), transcutaneous spinal Direct Current Stimulation (tsDCS), transcranial alternating current (tACS), and transcranial random noise (tRNS) stimulation or their combinations, appears to be safe. No serious adverse events (SAEs) have been reported so far in over 18,000 sessions administered to healthy subjects, neurological and psychiatric patients, as summarized here. Moderate adverse events (AEs), as defined by the necessity to intervene, are rare, and include skin burns with tDCS due to suboptimal electrode-skin contact. Very rarely mania or hypomania was induced in patients with depression (11 documented cases), yet a causal relationship is difficult to prove because of the low incidence rate and limited numbers of subjects in controlled trials. Mild AEs (MAEs) include headache and fatigue following stimulation as well as prickling and burning sensations occurring during tDCS at peak-to-baseline intensities of 1–2 mA and during tACS at higher peak-to-peak intensities above 2 mA. The prevalence of published AEs is different in studies specifically assessing AEs vs. those not assessing them, being higher in the former. AEs are frequently reported by individuals receiving placebo stimulation. The profile of AEs in terms of frequency, magnitude and type is comparable in healthy and clinical populations, and this is also the case for more vulnerable populations, such as children, elderly persons, or pregnant women. Combined interventions (e.g., co-application of drugs, electrophysiological measurements, neuroimaging) were not associated with further safety issues. Safety is established for low-intensity ‘conventional’ TES defined as <4 mA, up to 60 min duration per day. Animal studies and modeling evidence indicate that brain injury could occur at predicted current densities in the brain of 6.3–13 A/m2that are over an order of magnitude above

Published
2017

22. Beaming Signal Sources in Measurement of Focal Visual Evoked Cortical Potentials

Author

ILMENAU TECHNICAL UNIV (GERMANY) DEPT OF BIOMEDICAL ENGINEERING, Husar, P., Berkes, S., Henning, G., Plagwitz, K. U., Schellhorn, K., ILMENAU TECHNICAL UNIV (GERMANY) DEPT OF BIOMEDICAL ENGINEERING, Husar, P., Berkes, S., Henning, G., Plagwitz, K. U., and Schellhorn, K.

Abstract

VECPs (Visual Evoked Cortical Potential) after focal stimulation used in perimetry have weak amplitudes in comparison to the spontaneous EEG, thus the SNR (Signal-to-Noise Ratio) falls off down to -20dB and less. The shape of the VECP waves depends on several parameters and is unknown in general. Then for SNR enhancement and signal detection shape-independent methods can be used only. The most common of them is the stimulus synchronized averaging, which causes cumulative prolongation of the measurement time corresponding to the averaging order. For online measurements of VECP other ways in signal improvement are needed. in this paper a new method for SNR enhancement based on beam forming is introduced. While the anatomical structures of sources generating the focal VECP are known roughly and the electrode positions have sufficient density over the visual cortex, signal sources can be focused by controlling the channel delay., Papers from the 23rd Annual International conference of the IEEE Engineering in Medicine and Biology Society, October 25-28, 2001, held in Istanbul, Turkey. See also ADM001351 for entire conference on cd-rom.

Published
2001

29. Portable qEEG and HD-tCS device for point-of-injury Traumatic Brain Injury diagnostics

Author

Blobel, B., Goossen, W., Strisland, F., Vedum, J., Liverud, A., Dalgard, S., Brødreskift, T., Albert, B., Noyvirt, A., Setchi, Rossitza, Vene, K., Herranen, H., Kirs, M., Antal, A, Schellhorn, K., Sjaaheim, H., Blobel, B., Goossen, W., Strisland, F., Vedum, J., Liverud, A., Dalgard, S., Brødreskift, T., Albert, B., Noyvirt, A., Setchi, Rossitza, Vene, K., Herranen, H., Kirs, M., Antal, A, Schellhorn, K., and Sjaaheim, H.

Abstract

Mild Traumatic Brain Injury (mTBI) can cause prolonged or permanent injuries if left undetected and ignored. It is therefore of great interest to lower the threshold for diagnosis of individuals with mTBI injury. We report on the development of a prototype of a portable quantified EEG system intended for inthe-field mTBI diagnostics. The 32-electrode system is fully battery driven, is interfaced with a control unit being part of a telemedicine care system. All electrodes are individually configurable sot that they can be used for wet or dry qEEG electrodes. All electrodes can also be individually configured to allow Trans-Cranial Current Stimulation (tCS) sessions in DC, AC or other current supply modalities. The system has been functionality tested in end-to-end configurations where all control and measurement signals are forwarded between the head device on one side and the user interface and telemedicine system on the other. Tests confirm that the device can acquire and forward EEG data from 32 channels in parallel at target sensitivities up to 1 kHZ sampling frequencies. Tests further confirm that all electrodes can be individually configured for DC or any alternating current waveform up to 1 kHz. Additional device clinical evaluation is planned.

37. A checklist for assessing the methodological quality of concurrent tES-fMRI studies (ContES checklist): A consensus study and statement

Author

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

38. Enhancing EEG data quality and precision for cloud-based clinical applications: an evaluation of the SLOG framework.

Author

Ghani A, Heinrich H, Brown T, and Schellhorn K

Subjects
Humans, Signal-To-Noise Ratio, Eye Movements physiology, Electrooculography methods, Data Accuracy, Electroencephalography methods, Cloud Computing, Signal Processing, Computer-Assisted, Artifacts, Brain diagnostic imaging, Brain physiology, Algorithms
Abstract

Automation is revamping our preprocessing pipelines, and accelerating the delivery of personalized digital medicine. It improves efficiency, reduces costs, and allows clinicians to treat patients without significant delays. However, the influx of multimodal data highlights the need to protect sensitive information, such as clinical data, and safeguard data fidelity. One of the neuroimaging modalities that produces large amounts of time-series data is Electroencephalography (EEG). It captures the neural dynamics in a task or resting brain state with high temporal resolution. EEG electrodes placed on the scalp acquire electrical activity from the brain. These electrical potentials attenuate as they cross multiple layers of brain tissue and fluid yielding relatively weaker signals than noise-low signal-to-noise ratio. EEG signals are further distorted by internal physiological artifacts, such as eye movements (EOG) or heartbeat (ECG), and external noise, such as line noise (50 Hz). EOG artifacts, due to their proximity to the frontal brain regions, are particularly challenging to eliminate. Therefore, a widely used EOG rejection method, independent component analysis (ICA), demands manual inspection of the marked EOG components before they are rejected from the EEG data. We underscore the inaccuracy of automatized ICA rejection and provide an auxiliary algorithm-Second Layer Inspection for EOG (SLOG) in the clinical environment. SLOG based on spatial and temporal patterns of eye movements, re-examines the already marked EOG artifacts and confirms no EEG-related activity is mistakenly eliminated in this artifact rejection step. SLOG achieved a 99% precision rate on the simulated dataset while 85% precision on the real EEG dataset. One of the primary considerations for cloud-based applications is operational costs, including computing power. Algorithms like SLOG allow us to maintain data fidelity and precision without overloading the cloud platforms and maxing out our budgets., (Creative Commons Attribution license.)

Published
2024
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39. The consequences of the new European reclassification of non-invasive brain stimulation devices and the medical device regulations pose an existential threat to research and treatment: An invited opinion paper.

Author

Antal A, Ganho-Ávila A, Assecondi S, Barbour T, Bjekić J, Blumberger DM, Bolognini N, Brunelin J, Chanes L, Dale M, Dubbioso R, D'Urso G, Filipcic I, Filipović SR, Hirnstein M, Konings F, Langguth B, Leocani L, Sorkhabi MM, Mulder M, Nikander M, Nowak R, Oliviero A, Onarheim B, O'Shea J, Pallanti S, Rachid F, Rajão-Saraiva J, Rossi S, Sack AT, Sauvaget A, van der Scheer R, Schellhorn K, Soria-Frisch A, Szekely D, Tankisi H, Cj Taylor P, Tendolkar I, Uusitalo S, and Baeken C

Subjects
Humans, Biomedical Research, Device Approval legislation & jurisprudence, Europe, European Union, Medical Device Legislation, Transcranial Direct Current Stimulation, Transcranial Magnetic Stimulation methods
Abstract

A significant amount of European basic and clinical neuroscience research includes the use of transcranial magnetic stimulation (TMS) and low intensity transcranial electrical stimulation (tES), mainly transcranial direct current stimulation (tDCS). Two recent changes in the EU regulations, the introduction of the Medical Device Regulation (MDR) (2017/745) and the Annex XVI have caused significant problems and confusions in the brain stimulation field. The negative consequences of the MDR for non-invasive brain stimulation (NIBS) have been largely overlooked and until today, have not been consequently addressed by National Competent Authorities, local ethical committees, politicians and by the scientific communities. In addition, a rushed bureaucratic decision led to seemingly wrong classification of NIBS products without an intended medical purpose into the same risk group III as invasive stimulators. Overregulation is detrimental for any research and for future developments, therefore researchers, clinicians, industry, patient representatives and an ethicist were invited to contribute to this document with the aim of starting a constructive dialogue and enacting positive changes in the regulatory environment., (Copyright © 2024 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.)

Published
2024
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40. Digitalized transcranial electrical stimulation: A consensus statement.

Author

Brunoni AR, Ekhtiari H, Antal A, Auvichayapat P, Baeken C, Benseñor IM, Bikson M, Boggio P, Borroni B, Brighina F, Brunelin J, Carvalho S, Caumo W, Ciechanski P, Charvet L, Clark VP, Cohen Kadosh R, Cotelli M, Datta A, Deng ZD, De Raedt R, De Ridder D, Fitzgerald PB, Floel A, Frohlich F, George MS, Ghobadi-Azbari P, Goerigk S, Hamilton RH, Jaberzadeh SJ, Hoy K, Kidgell DJ, Zonoozi AK, Kirton A, Laureys S, Lavidor M, Lee K, Leite J, Lisanby SH, Loo C, Martin DM, Miniussi C, Mondino M, Monte-Silva K, Morales-Quezada L, Nitsche MA, Okano AH, Oliveira CS, Onarheim B, Pacheco-Barrios K, Padberg F, Nakamura-Palacios EM, Palm U, Paulus W, Plewnia C, Priori A, Rajji TK, Razza LB, Rehn EM, Ruffini G, Schellhorn K, Zare-Bidoky M, Simis M, Skorupinski P, Suen P, Thibaut A, Valiengo LCL, Vanderhasselt MA, Vanneste S, Venkatasubramanian G, Violante IR, Wexler A, Woods AJ, and Fregni F

Subjects
Consensus, Electric Stimulation, Humans, Telemedicine, Transcranial Direct Current Stimulation methods
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., (Copyright © 2022 International Federation of Clinical Neurophysiology. All rights reserved.)

Published
2022
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41. Benchmarking the effects of transcranial temporal interference stimulation (tTIS) in humans.

Author

von Conta J, Kasten FH, Schellhorn K, Ćurčić-Blake B, Aleman A, and Herrmann CS

Subjects
Animals, Brain, Computer Simulation, Humans, Benchmarking, Transcranial Direct Current Stimulation
Abstract

Deep brain stimulation (DBS) provides clinical benefits for several neurological and psychiatric conditions. By overcoming the limitations and risks of conventional DBS, transcranial temporal interference stimulation (tTIS) has the potential to offer non-invasive stimulation of deep brain regions. However, research that investigates the efficacy of tTIS is limited to animal studies or computer simulations and its capability to modulate neural oscillations in humans has not been demonstrated so far. The method of tTIS is hypothesized to elicit its effects via neural entrainment, corresponding to the supposed mechanism of action underlying transcranial alternating current stimulation (tACS), another, more established non-invasive brain stimulation technique. Physiological effects of tACS are well established for cortical brain oscillations, but not for deep brain structures. In particular, aftereffects on the power of parieto-occipital alpha oscillations have been shown repeatedly. In a first attempt to test the efficacy of tTIS in the human brain, the current study thus seeks to compare the effects of tTIS to the well-studied aftereffect of tACS in the cortex. To investigate this research question, the current study compared MEG-recorded brain activity during a simple visual change detection task in 34 healthy subjects pre- and post-tTIS. Additionally, the effects of tTIS were contrasted to conventional tACS and a control stimulation. We expected that the parieto-occipital α-power will increase after tTIS and tACS, in contrast to the control stimulation. Overall, no difference between the experimental groups (tTIS, tACS and control stimulation) were found regarding the source-projected increase in α-power. Based on the results of the study two hypothesis can be made: tTIS, tACS and the control stimulation condition don't have an effect on human brain oscillations in the α-band, or, any experimental conditions of the current study can modulate brain oscillations in the α-band. Both hypotheses emphasize the importance of further studies investigating different carrier frequencies, and the comparison to sham stimulation., Competing Interests: Declaration of competing interest CSH holds a patent on brain stimulation. KS is the manufacturer of the advanced DC stimulator plus (Neuroconn, Ilmenau, Germany). JC, FHK, BCB and AA declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Published
2022
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42. A checklist for assessing the methodological quality of concurrent tES-fMRI studies (ContES checklist): a consensus study and statement.

Author

Ekhtiari H, Ghobadi-Azbari P, Thielscher A, Antal A, Li LM, Shereen AD, Cabral-Calderin Y, Keeser D, Bergmann TO, Jamil A, Violante IR, Almeida J, Meinzer M, Siebner HR, Woods AJ, Stagg CJ, Abend R, Antonenko D, Auer T, Bächinger M, Baeken C, Barron HC, Chase HW, Crinion J, Datta A, Davis MH, Ebrahimi M, Esmaeilpour Z, Falcone B, Fiori V, Ghodratitoostani I, Gilam G, Grabner RH, Greenspan JD, Groen G, Hartwigsen G, Hauser TU, Herrmann CS, Juan CH, Krekelberg B, Lefebvre S, Liew SL, Madsen KH, Mahdavifar-Khayati R, Malmir N, Marangolo P, Martin AK, Meeker TJ, Ardabili HM, Moisa M, Momi D, Mulyana B, Opitz A, Orlov N, Ragert P, Ruff CC, 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 CA, Zare-Bidoky M, Zhang X, Zoefel B, Nitsche MA, and Bikson M

Subjects
Consensus, Magnetic Resonance Imaging, Reproducibility of Results, Checklist, Transcranial Direct Current Stimulation
Abstract

Low-intensity transcranial electrical stimulation (tES), including alternating or direct current stimulation, applies weak electrical stimulation to modulate the activity of brain circuits. Integration of tES with concurrent functional MRI (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. The objective of this work was to develop a consensus-based checklist of reporting standards for concurrent tES-fMRI studies to support methodological rigor, transparency and reproducibility (ContES checklist). A two-phase Delphi consensus process was conducted by a steering committee (SC) of 13 members and 49 expert panelists through the International Network of the tES-fMRI Consortium. The process began with a circulation of a preliminary checklist of essential items and additional recommendations, developed by the SC on the basis of 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 by using the checklist. Experts refined the checklist through the revision and rating phases, leading to a checklist with three categories of essential items and additional recommendations: (i) technological factors, (ii) safety and noise tests and (iii) 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. In conclusion, 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., (© 2022. © The Author(s).)

Published
2022
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43. Novel flexible cap for application of transcranial electrical stimulation: a usability study.

Author

Hunold A, Ortega D, Schellhorn K, and Haueisen J

Subjects
Electrodes, Feasibility Studies, Female, Finite Element Analysis, Healthy Volunteers, Humans, Male, Young Adult, Mechanical Phenomena, Transcranial Direct Current Stimulation instrumentation
Abstract

Background: Advances in transcranial electrical stimulation (tES) are hampered by the conventional rubber electrodes manually attached to the head with rubber bands. This procedure limits montages to a few electrodes, is error prone with respect to electrode configurations and is burdensome for participants and operators. A newly developed flexible cap with integrated textile stimulation electrodes was compared to the conventional setup of rubber electrodes inserted into sponges fixated by rubber bands, with respect to usability and reliability. Two operators applied both setups to 20 healthy volunteers participating in the study. Electrode position and impedance measures as well as subjective evaluations from participants and operators were obtained throughout the stimulation sessions., Results: Our results demonstrated the superiority of the flexible cap by means of significantly higher electrode configuration reproducibility and a more efficient application. Both, operators and volunteers evaluated the flexible cap as easier to use and more comfortable to wear when compared to the conventional setup., Conclusion: In conclusion, the new cap improves existing and opens new application scenarios for tES.

Published
2020
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44. Sham tDCS: A hidden source of variability? Reflections for further blinded, controlled trials.

Author

Fonteneau C, Mondino M, Arns M, Baeken C, Bikson M, Brunoni AR, Burke MJ, Neuvonen T, Padberg F, Pascual-Leone A, Poulet E, Ruffini G, Santarnecchi E, Sauvaget A, Schellhorn K, Suaud-Chagny MF, Palm U, and Brunelin J

Subjects
Humans, Reproducibility of Results, Research Design standards, Randomized Controlled Trials as Topic, Transcranial Direct Current Stimulation standards
Abstract

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique increasingly used to modulate neural activity in the living brain. In order to establish the neurophysiological, cognitive or clinical effects of tDCS, most studies compare the effects of active tDCS to those observed with a sham tDCS intervention. In most cases, sham tDCS consists in delivering an active stimulation for a few seconds to mimic the sensations observed with active tDCS and keep participants blind to the intervention. However, to date, sham-controlled tDCS studies yield inconsistent results, which might arise in part from sham inconsistencies. Indeed, a multiplicity of sham stimulation protocols is being used in the tDCS research field and might have different biological effects beyond the intended transient sensations. Here, we seek to enlighten the scientific community to this possible confounding factor in order to increase reproducibility of neurophysiological, cognitive and clinical tDCS studies., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Published
2019
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45. Novel bifunctional cap for simultaneous electroencephalography and transcranial electrical stimulation.

Author

Wunder S, Hunold A, Fiedler P, Schlegelmilch F, Schellhorn K, and Haueisen J

Subjects
Adult, Brain diagnostic imaging, Electrodes, Female, Humans, Male, Brain physiology, Electroencephalography instrumentation, Evoked Potentials, Visual physiology, Transcranial Direct Current Stimulation instrumentation
Abstract

Neuromodulation induced by transcranial electric stimulation (TES) exhibited promising potential for clinical practice. However, the underlying mechanisms remain subject of research. The combination of TES and electroencephalography (EEG) offers great potential for investigating these mechanisms and brain function in general, especially when performed simultaneously. In conventional applications, the combination of EEG and TES suffers from limitations on the electrode level (gel for electrode-skin interface) and the usability level (preparation time, reproducibility of positioning). To overcome these limitations, we designed a bifunctional cap for simultaneous TES-EEG applications. We used novel electrode materials, namely textile stimulation electrodes and dry EEG electrodes integrated in a flexible textile cap. We verified the functionality of this cap by analysing the effect of TES on visual evoked potentials (VEPs). In accordance with previous reports using standard TES, the amplitude of the N75 component was significantly decreased post-stimulation, indicating the feasibility of using this novel flexible cap for simultaneous TES and EEG. Further, we found a significant reduction of the P100 component only during TES, indicating a different brain modulation effect during and after TES. In conclusion, the novel bifunctional cap offers a novel tool for simultaneous TES-EEG applications in clinical research, therapy monitoring and closed-loop stimulation.

Published
2018
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46. A biofeedback intervention to control impulsiveness in a severely personality disordered forensic patient.

Author

Howard R, Schellhorn K, and Lumsden J

Subjects
Adult, Antimanic Agents therapeutic use, Carbamazepine therapeutic use, Cerebral Cortex physiopathology, Eye Movement Measurements, Humans, Impulsive Behavior physiopathology, Libido drug effects, Male, Neuropsychological Tests, Patient Compliance psychology, Personality Disorders psychology, Secondary Prevention, Self Report, Sex Offenses legislation & jurisprudence, Treatment Outcome, Triptorelin Pamoate therapeutic use, Attention physiology, Biofeedback, Psychology methods, Contingent Negative Variation physiology, Criminals psychology, Impulsive Behavior prevention & control, Personality Disorders therapy
Abstract

Impulsiveness in personality disordered forensic patients is associated with poor treatment completion and high risk of re-offending. A biofeedback training protocol, previously found to reduce impulsiveness and improve attention in children with Attention Deficit Hyperactivity Disorder, was used in an initial attempt to reduce impulsiveness in a severely personality disordered man with borderline, antisocial and histrionic features. Electrocortical, behavioural and self-report measures of impulsiveness were taken before and immediately following 6 weeks of biofeedback training and at 3 months follow-up. The patient successfully engaged with the intervention. His self-reports of reduced impulsiveness and improved attention were corroborated by behavioural and electrocortical measures that indicated reduced impulsiveness and better focused attention. Results suggest this intervention might prove useful in improving behavioural and emotional self-regulation in severely personality disordered patients., (Copyright © 2013 John Wiley & Sons, Ltd.)

Published
2013
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47. [Determined signal responses in visually evoked stimulus responses].

Author

Schellhorn K, Henning G, Hoenecke O, and Husar P

Subjects
Child, Preschool, Humans, Infant, Photic Stimulation, Reaction Time physiology, Retina physiology, Visual Cortex physiology, Electroencephalography instrumentation, Evoked Potentials, Visual physiology, Signal Processing, Computer-Assisted instrumentation
Published
1997

48. [EEG/MEG source localization in local stimulation of the retina].

Author

Schellhorn K, Hoenecke O, Haueisen J, Schultheiss B, Henning G, Husar P, and Nowak H

Subjects
Computer Simulation, Evoked Potentials, Visual physiology, Humans, Photic Stimulation, Sensitivity and Specificity, Software, Visual Field Tests instrumentation, Brain Mapping instrumentation, Electroencephalography instrumentation, Magnetoencephalography instrumentation, Retina physiology, Signal Processing, Computer-Assisted instrumentation, Visual Cortex physiology, Visual Fields physiology
Published
1997
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49. [3D visual evoked potential detection with circular T2 statistics].

Author

Hoenecke O, Ivanova G, Schellhorn K, and Henning G

Subjects
Brain Mapping instrumentation, Humans, Occipital Lobe physiology, Photic Stimulation, Sensitivity and Specificity, Electroencephalography instrumentation, Evoked Potentials, Visual physiology, Image Processing, Computer-Assisted instrumentation, Visual Field Tests instrumentation
Published
1997
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