Digitalized transcranial electrical stimulation: A consensus statement

Andre R. Brunoni; Hamed Ekhtiari; Andrea Antal; Paradee Auvichayapat; Chris Baeken; Isabela M. Benseñor; Marom Bikson; Paulo Boggio; Barbara Borroni; Filippo Brighina; Jerome Brunelin; Sandra Carvalho; Wolnei Caumo; Patrick Ciechanski; Leigh Charvet; Vincent P. Clark; Roi Cohen Kadosh; Maria Cotelli; Abhishek Datta; Zhi De Deng; Rudi De Raedt; Dirk De Ridder; Paul B. Fitzgerald; Agnes Floel; Flavio Frohlich; Mark S. George; Peyman Ghobadi-Azbari; Stephan Goerigk; Roy H. Hamilton; Shapour J. Jaberzadeh; Kate Hoy; Dawson J. Kidgell; Arash Khojasteh Zonoozi; Adam Kirton; Steven Laureys; Michal Lavidor; Kiwon Lee; Jorge Leite; Sarah H. Lisanby; Colleen Loo; Donel M. Martin; Carlo Miniussi; Marine Mondino; Katia Monte-Silva; Leon Morales-Quezada; Michael A. Nitsche; Alexandre H. Okano; Claudia S. Oliveira; Balder Onarheim; Kevin Pacheco-Barrios; Frank Padberg; Ester M. Nakamura-Palacios; Ulrich Palm; Walter Paulus; Christian Plewnia; Alberto Priori; Tarek K. Rajji; Lais B. Razza; Erik M. Rehn; Giulio Ruffini; Klaus Schellhorn; Mehran Zare-Bidoky; Marcel Simis; Pawel Skorupinski; Paulo Suen; Aurore Thibaut; Leandro C.L. Valiengo; Marie Anne Vanderhasselt; Sven Vanneste; Ganesan Venkatasubramanian; Ines R. Violante; Anna Wexler; Adam J. Woods; Felipe Fregni

doi:10.1016/j.clinph.2022.08.018

Digitalized transcranial electrical stimulation: A consensus statement

Andre R. Brunoni, Hamed Ekhtiari, Andrea Antal, Paradee Auvichayapat, Chris Baeken, Isabela M. Benseñor, Marom Bikson, Paulo Boggio, Barbara Borroni, Filippo Brighina, Jerome Brunelin, Sandra Carvalho, Wolnei Caumo, Patrick Ciechanski, Leigh Charvet, Vincent P. Clark, Roi Cohen Kadosh, Maria Cotelli, Abhishek Datta, Zhi De DengRudi De Raedt, Dirk De Ridder, Paul B. Fitzgerald, Agnes Floel, Flavio Frohlich, Mark S. George, Peyman Ghobadi-Azbari, Stephan Goerigk, Roy H. Hamilton, Shapour J. Jaberzadeh, Kate Hoy, Dawson J. Kidgell, Arash Khojasteh Zonoozi, Adam Kirton, Steven Laureys, Michal Lavidor, Kiwon Lee, Jorge Leite, Sarah H. Lisanby, Colleen Loo, Donel M. Martin, Carlo Miniussi, Marine Mondino, Katia Monte-Silva, Leon Morales-Quezada, Michael A. Nitsche, Alexandre H. Okano, Claudia S. Oliveira, Balder Onarheim, Kevin Pacheco-Barrios, Frank Padberg, Ester M. Nakamura-Palacios, Ulrich Palm, Walter Paulus, Christian Plewnia, Alberto Priori, Tarek K. Rajji, Lais B. Razza, Erik M. Rehn, Giulio Ruffini, Klaus Schellhorn, Mehran Zare-Bidoky, Marcel Simis, Pawel Skorupinski, Paulo Suen, Aurore Thibaut, Leandro C.L. Valiengo, Marie Anne Vanderhasselt, Sven Vanneste, Ganesan Venkatasubramanian, Ines R. Violante, Anna Wexler, Adam J. Woods, Felipe Fregni

Department of Psychology

Research output: Contribution to journal › Article › peer-review

13 Scopus citations

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.

Original language	English
Pages (from-to)	154-165
Number of pages	12
Journal	Clinical Neurophysiology
Volume	143
DOIs	https://doi.org/10.1016/j.clinph.2022.08.018
State	Published - Nov 2022

Bibliographical note

Publisher Copyright:
© 2022 International Federation of Clinical Neurophysiology

Funding

Funders	Funder number
Eunice Kennedy Shriver National Institute of Child Health and Human Development	R01HD082302

Keywords

Delphi panel
Digital health
Mobile Health
Non-invasive neuromodulation
Systematic review

Access to Document

10.1016/j.clinph.2022.08.018

Cite this

Brunoni, A. R., Ekhtiari, H., Antal, A., Auvichayapat, P., Baeken, C., Benseñor, 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, M., Datta, A., ... Fregni, F. (2022). Digitalized transcranial electrical stimulation: A consensus statement. Clinical Neurophysiology, 143, 154-165. https://doi.org/10.1016/j.clinph.2022.08.018

@article{55a9df719ed94bccac2080af5c98495f,

title = "Digitalized transcranial electrical stimulation: A consensus statement",

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.",

keywords = "Delphi panel, Digital health, Mobile Health, Non-invasive neuromodulation, Systematic review",

author = "Brunoni, {Andre R.} and Hamed Ekhtiari and Andrea Antal and Paradee Auvichayapat and Chris Baeken and Bense{\~n}or, {Isabela M.} and Marom Bikson and Paulo Boggio and Barbara Borroni and Filippo Brighina and Jerome Brunelin and Sandra Carvalho and Wolnei Caumo and Patrick Ciechanski and Leigh Charvet and Clark, {Vincent P.} and {Cohen Kadosh}, Roi and Maria Cotelli and Abhishek Datta and Deng, {Zhi De} and {De Raedt}, Rudi and {De Ridder}, Dirk and Fitzgerald, {Paul B.} and Agnes Floel and Flavio Frohlich and George, {Mark S.} and Peyman Ghobadi-Azbari and Stephan Goerigk and Hamilton, {Roy H.} and Jaberzadeh, {Shapour J.} and Kate Hoy and Kidgell, {Dawson J.} and Zonoozi, {Arash Khojasteh} and Adam Kirton and Steven Laureys and Michal Lavidor and Kiwon Lee and Jorge Leite and Lisanby, {Sarah H.} and Colleen Loo and Martin, {Donel M.} and Carlo Miniussi and Marine Mondino and Katia Monte-Silva and Leon Morales-Quezada and Nitsche, {Michael A.} and Okano, {Alexandre H.} and Oliveira, {Claudia S.} and Balder Onarheim and Kevin Pacheco-Barrios and Frank Padberg and Nakamura-Palacios, {Ester M.} and Ulrich Palm and Walter Paulus and Christian Plewnia and Alberto Priori and Rajji, {Tarek K.} and Razza, {Lais B.} and Rehn, {Erik M.} and Giulio Ruffini and Klaus Schellhorn and Mehran Zare-Bidoky and Marcel Simis and Pawel Skorupinski and Paulo Suen and Aurore Thibaut and Valiengo, {Leandro C.L.} and Vanderhasselt, {Marie Anne} and Sven Vanneste and Ganesan Venkatasubramanian and Violante, {Ines R.} and Anna Wexler and Woods, {Adam J.} and Felipe Fregni",

note = "Publisher Copyright: {\textcopyright} 2022 International Federation of Clinical Neurophysiology",

year = "2022",

month = nov,

doi = "10.1016/j.clinph.2022.08.018",

language = "אנגלית",

volume = "143",

pages = "154--165",

journal = "Clinical Neurophysiology",

issn = "1388-2457",

publisher = "Elsevier Ireland Ltd",

}

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 & Fregni, F 2022, 'Digitalized transcranial electrical stimulation: A consensus statement', Clinical Neurophysiology, vol. 143, pp. 154-165. https://doi.org/10.1016/j.clinph.2022.08.018

TY - JOUR

T1 - Digitalized transcranial electrical stimulation

T2 - A consensus statement

AU - Brunoni, Andre R.

AU - Ekhtiari, Hamed

AU - Antal, Andrea

AU - Auvichayapat, Paradee

AU - Baeken, Chris

AU - Benseñor, Isabela M.

AU - Bikson, Marom

AU - Boggio, Paulo

AU - Borroni, Barbara

AU - Brighina, Filippo

AU - Brunelin, Jerome

AU - Carvalho, Sandra

AU - Caumo, Wolnei

AU - Ciechanski, Patrick

AU - Charvet, Leigh

AU - Clark, Vincent P.

AU - Cohen Kadosh, Roi

AU - Cotelli, Maria

AU - Datta, Abhishek

AU - Deng, Zhi De

AU - De Raedt, Rudi

AU - De Ridder, Dirk

AU - Fitzgerald, Paul B.

AU - Floel, Agnes

AU - Frohlich, Flavio

AU - George, Mark S.

AU - Ghobadi-Azbari, Peyman

AU - Goerigk, Stephan

AU - Hamilton, Roy H.

AU - Jaberzadeh, Shapour J.

AU - Hoy, Kate

AU - Kidgell, Dawson J.

AU - Zonoozi, Arash Khojasteh

AU - Kirton, Adam

AU - Laureys, Steven

AU - Lavidor, Michal

AU - Lee, Kiwon

AU - Leite, Jorge

AU - Lisanby, Sarah H.

AU - Loo, Colleen

AU - Martin, Donel M.

AU - Miniussi, Carlo

AU - Mondino, Marine

AU - Monte-Silva, Katia

AU - Morales-Quezada, Leon

AU - Nitsche, Michael A.

AU - Okano, Alexandre H.

AU - Oliveira, Claudia S.

AU - Onarheim, Balder

AU - Pacheco-Barrios, Kevin

AU - Padberg, Frank

AU - Nakamura-Palacios, Ester M.

AU - Palm, Ulrich

AU - Paulus, Walter

AU - Plewnia, Christian

AU - Priori, Alberto

AU - Rajji, Tarek K.

AU - Razza, Lais B.

AU - Rehn, Erik M.

AU - Ruffini, Giulio

AU - Schellhorn, Klaus

AU - Zare-Bidoky, Mehran

AU - Simis, Marcel

AU - Skorupinski, Pawel

AU - Suen, Paulo

AU - Thibaut, Aurore

AU - Valiengo, Leandro C.L.

AU - Vanderhasselt, Marie Anne

AU - Vanneste, Sven

AU - Venkatasubramanian, Ganesan

AU - Violante, Ines R.

AU - Wexler, Anna

AU - Woods, Adam J.

AU - Fregni, Felipe

PY - 2022/11

Y1 - 2022/11

N2 - 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.

AB - 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.

KW - Delphi panel

KW - Digital health

KW - Mobile Health

KW - Non-invasive neuromodulation

KW - Systematic review

UR - http://www.scopus.com/inward/record.url?scp=85138108158&partnerID=8YFLogxK

U2 - 10.1016/j.clinph.2022.08.018

DO - 10.1016/j.clinph.2022.08.018

M3 - ???researchoutput.researchoutputtypes.contributiontojournal.article???

C2 - 36115809

AN - SCOPUS:85138108158

SN - 1388-2457

VL - 143

SP - 154

EP - 165

JO - Clinical Neurophysiology

JF - Clinical Neurophysiology

ER -

Digitalized transcranial electrical stimulation: A consensus statement

Abstract

Bibliographical note

Funding

Keywords

Access to Document

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