. 2022 Nov:143:154-165.

doi: 10.1016/j.clinph.2022.08.018. Epub 2022 Sep 5.

Digitalized transcranial electrical stimulation: A consensus statement

Andre R Brunoni¹, Hamed Ekhtiari², Andrea Antal³, Paradee Auvichayapat⁴, Chris Baeken⁵, Isabela M Benseñor⁶, Marom Bikson⁷, Paulo Boggio⁸, Barbara Borroni⁹, Filippo Brighina¹⁰, Jerome Brunelin¹¹, Sandra Carvalho¹², Wolnei Caumo¹³, Patrick Ciechanski¹⁴, Leigh Charvet¹⁵, Vincent P Clark¹⁶, Roi Cohen Kadosh¹⁷, Maria Cotelli¹⁸, Abhishek Datta¹⁹, Zhi-De Deng²⁰, Rudi De Raedt²¹, Dirk De Ridder²², Paul B Fitzgerald²³, Agnes Floel²⁴, Flavio Frohlich²⁵, Mark S George²⁶, Peyman Ghobadi-Azbari²⁷, Stephan Goerigk²⁸, Roy H Hamilton²⁹, Shapour J Jaberzadeh³⁰, Kate Hoy²³, Dawson J Kidgell³¹, Arash Khojasteh Zonoozi³², Adam Kirton³³, Steven Laureys³⁴, Michal Lavidor³⁵, Kiwon Lee³⁶, Jorge Leite³⁷, Sarah H Lisanby²⁰, Colleen Loo³⁸, Donel M Martin³⁸, Carlo Miniussi³⁹, Marine Mondino⁴⁰, Katia Monte-Silva⁴¹, Leon Morales-Quezada⁴², Michael A Nitsche⁴³, Alexandre H Okano⁴⁴, Claudia S Oliveira⁴⁵, Balder Onarheim⁴⁶, Kevin Pacheco-Barrios⁴⁷, Frank Padberg⁴⁸, Ester M Nakamura-Palacios⁴⁹, Ulrich Palm⁵⁰, Walter Paulus⁵¹, Christian Plewnia⁵², Alberto Priori⁵³, Tarek K Rajji⁵⁴, Lais B Razza⁵⁵, Erik M Rehn⁵⁶, Giulio Ruffini⁵⁷, Klaus Schellhorn⁵⁸, Mehran Zare-Bidoky⁵⁹, Marcel Simis⁶⁰, Pawel Skorupinski⁵⁷, Paulo Suen⁵⁵, Aurore Thibaut⁶¹, Leandro C L Valiengo⁶², Marie-Anne Vanderhasselt⁶³, Sven Vanneste⁶⁴, Ganesan Venkatasubramanian⁶⁵, Ines R Violante¹⁷, Anna Wexler⁶⁶, Adam J Woods⁶⁷, Felipe Fregni⁶⁸

Affiliations

¹ Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, São Paulo, Brazil; Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Service of Interdisciplinary Neuromodulation (SIN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil. Electronic address: brunoni@usp.br.
² Laureate Institute for Brain Research (LIBR), Tulsa, OK, USA.
³ Department of Neurology, University Medical Center Göttingen, Göttingen, Germany.
⁴ Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
⁵ Vrije Universiteit Brussel (VUB): Department of Psychiatry University Hospital (UZBrussel), Brussels, Belgium; Department of Head and Skin, Ghent University Hospital, Ghent University, Ghent, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium; Eindhoven University of Technology, Department of Electrical Engineering, the Netherlands.
⁶ Center for Clinical and Epidemiological Research, University of São Paulo, São Paulo, Brazil.
⁷ The Department of Biomedical Engineering, The City College of New York, The City University of New York, NY, USA.
⁸ Social and Cognitive Neuroscience Laboratory, Center for Biological Science and Health, Mackenzie Presbyterian University, São Paulo, Brazil.
⁹ Centre for Neurodegenerative Disorders, Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Italy.
¹⁰ Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D.), University of Palermo, Palermo, Italy.
¹¹ Centre Hospitalier le Vinatier, Bron, France; INSERM U1028, CNRS UMR 5292, PSYR2 Team, Centre de recherche en Neurosciences de Lyon (CRNL), Université Lyon 1, Lyon, France.
¹² Translational Neuropsychology Lab, Department of Education and Psychology and William James Center for Research (WJCR), University of Aveiro, Campus Universitário de Santiago, Aveiro, Portugal.
¹³ Post-Graduate Program in Medical Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Brazil; Laboratory of Pain and Neuromodulation at Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil; Pain and Palliative Care Service at HCPA, Brazil; Department of Surgery, School of Medicine, UFRGS, Brazil.
¹⁴ Faculty of Medicine and Dentistry, University of Alberta, 1-002 Katz Group Centre for Pharmacy and Health Research, Edmonton, Alberta, Canada.
¹⁵ Department of Neurology, NYU Grossman School of Medicine, New York, NY, USA.
¹⁶ Psychology Clinical Neuroscience Center, Department of Psychology, The University of New Mexico, Albuquerque, NM, USA.
¹⁷ School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.
¹⁸ Neuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.
¹⁹ Research and Development, Soterix Medical Inc., New York, USA.
²⁰ Noninvasive Neuromodulation Unit, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, Bethesda, MD, USA.
²¹ Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.
²² Section of Neurosurgery, Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
²³ Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash University Department of Psychiatry, Camberwell, Victoria, Australia.
²⁴ Department of Neurology, University Medicine Greifswald, Greifswald, Germany; German Center for Neurodegenerative Diseases (DZNE), Rostock/Greifswald, Germany.
²⁵ Department of Psychiatry, University of North Carolina, Chapel Hill, NC, USA; Carolina Center for Neurostimulation, University of North Carolina, Chapel Hill, NC, USA; Neuroscience Center, University of North Carolina, Chapel Hill, NC, USA; Department of Cell Biology and Physiology, University of North Carolina, Chapel Hill, NC, USA; Department of Biomedical Engineering, University of North Carolina, Chapel Hill, NC, USA; Department of Neurology, University of North Carolina, Chapel Hill, NC, USA.
²⁶ Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, USA.
²⁷ Iranian National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran, Iran; Department of Biomedical Engineering, Shahed University, Tehran, Iran.
²⁸ Department of Psychiatry and Psychotherapy, LMU Hospital, Munich, Germany; Department of Psychological Methodology and Assessment, LMU, Munich, Germany; Hochschule Fresenius, University of Applied Sciences, Munich, Germany.
²⁹ Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.
³⁰ Department of Physiotherapy, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.
³¹ Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Science, Monash University, Melbourne, Australia.
³² Iranian National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran, Iran; Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
³³ Department of Clinical Neurosciences and Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.
³⁴ Coma Science Group, GIGA-Consciousness, GIGA Institute, University of Liège, Liege, Belgium.
³⁵ Bar Ilan University, Department of Psychology, and the Gonda Brain Research Center, Israel.
³⁶ Ybrain Corporation, Gyeonggi-do, Republic of Korea.
³⁷ INPP, Portucalense University, Porto, Portugal.
³⁸ School of Psychiatry, University of New South Wales, Sydney, NSW, Australia; Black Dog Institute, Sydney, NSW, Australia.
³⁹ Center for Mind/Brain Sciences - CIMeC, University of Trento, Rovereto, Italy.
⁴⁰ Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D.), University of Palermo, Palermo, Italy; Centre Hospitalier le Vinatier, Bron, France.
⁴¹ Applied Neuroscience Laboratory, Department of Physical Therapy, Universidade Federal de Pernambuco, UFPE, Recife, PE, Brazil; NAPeN Network (Núcleo de Assistência e Pesquisa em Neuromodulação), Brazil.
⁴² Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA 02215, USA.
⁴³ Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany; Department of Neurology, University Medical Hospital Bergmannsheil, Bochum, Germany.
⁴⁴ NAPeN Network (Núcleo de Assistência e Pesquisa em Neuromodulação), Brazil; Center for Mathematics, Computation, and Cognition, Universidade Federal do ABC, São Bernardo do Campo, Brazil; Brazilian Institute of Neuroscience and Neurotechnology (BRAINN/CEPID-FAPESP), University of Campinas, Campinas, São Paulo, Brazil.
⁴⁵ Master's and Doctoral Program in Health Sciences, Faculty of Medical Sciences, Santa Casa de São Paulo, São Paulo, Brazil; Master's and Doctoral Program in Human Movement and Rehabilitation, Evangelical University of Goiás, Anápolis, Brazil.
⁴⁶ PlatoScience ApS, Copenhagen, Denmark.
⁴⁷ Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Universidad San Ignacio de Loyola, Vicerrectorado de Investigación, Unidad de Investigación para la Generación y Síntesis de Evidencias en Salud, Lima, Peru.
⁴⁸ Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.
⁴⁹ Laboratory of Cognitive Sciences and Neuropsychopharmacology, Program of Post-Graduation in Physiological Sciences, Health Sciences Center, Federal University of Espirito Santo, Vitória, ES, Brazil.
⁵⁰ Department of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany; Medical Park Chiemseeblick, Rasthausstr. 25, 83233 Bernau-Felden, Germany.
⁵¹ Department of Neurology. Ludwig Maximilians University Munich, Klinikum Großhadern, Marchioninistr, München, Germany.
⁵² Department of Psychiatry and Psychotherapy, Tübingen Center for Mental Health (TüCMH), Neurophysiology and Interventional Neuropsychiatry, University of Tübingen, Tübingen, Germany.
⁵³ Aldo Ravelli Research Center for Neurotechnology and Experimental Neurotherapeutics, Department of Health Sciences, University of Milan, Milan, Italy.
⁵⁴ Centre for Addiction and Mental Health, Toronto, Canada; Temerty Faculty of Medicine, University of Toronto, Toronto, Canada; Toronto Dementia Research Alliance, Toronto, Canada.
⁵⁵ Service of Interdisciplinary Neuromodulation (SIN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
⁵⁶ Flow Neuroscience, Malmö, Skane Lan, Sweden.
⁵⁷ Neuroelectrics Corporation, Cambridge, MA, USA.
⁵⁸ neuroConn GmbH, Ilmenau, Germany.
⁵⁹ Iranian National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran, Iran; School of Medicine, Shahid-Sadoughi University of Medical Sciences, Yazd, Iran.
⁶⁰ Physical and Rehabilitation Medicine Institute, General Hospital, Medical School of the University of Sao Paulo, São Paulo, Brazil.
⁶¹ Coma Science Group, GIGA-Consciousness & Centre du Cerveau, University and University Hospital of Liège, Liège, Belgium.
⁶² Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Service of Interdisciplinary Neuromodulation (SIN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
⁶³ Department of Head and Skin, Ghent University Hospital, Ghent University, Ghent, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium.
⁶⁴ Lab for Clinical & Integrative Neuroscience, Trinity College of Neuroscience, Trinity College Dublin, Ireland.
⁶⁵ Department of Psychiatry, National Institute of Mental Health and Neuro Sciences (NIMHANS), Bengaluru, India.
⁶⁶ Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA, USA.
⁶⁷ Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, USA; Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA; Department of Neuroscience, University of Florida, Gainesville, FL, USA.
⁶⁸ Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.

PMID: 36115809
PMCID: PMC10031774
DOI: 10.1016/j.clinph.2022.08.018

Digitalized transcranial electrical stimulation: A consensus statement

Andre R Brunoni et al. Clin Neurophysiol. 2022 Nov.

. 2022 Nov:143:154-165.

doi: 10.1016/j.clinph.2022.08.018. Epub 2022 Sep 5.

Authors

Affiliations

¹ Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, São Paulo, Brazil; Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Service of Interdisciplinary Neuromodulation (SIN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil. Electronic address: brunoni@usp.br.
² Laureate Institute for Brain Research (LIBR), Tulsa, OK, USA.
³ Department of Neurology, University Medical Center Göttingen, Göttingen, Germany.
⁴ Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
⁵ Vrije Universiteit Brussel (VUB): Department of Psychiatry University Hospital (UZBrussel), Brussels, Belgium; Department of Head and Skin, Ghent University Hospital, Ghent University, Ghent, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium; Eindhoven University of Technology, Department of Electrical Engineering, the Netherlands.
⁶ Center for Clinical and Epidemiological Research, University of São Paulo, São Paulo, Brazil.
⁷ The Department of Biomedical Engineering, The City College of New York, The City University of New York, NY, USA.
⁸ Social and Cognitive Neuroscience Laboratory, Center for Biological Science and Health, Mackenzie Presbyterian University, São Paulo, Brazil.
⁹ Centre for Neurodegenerative Disorders, Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Italy.
¹⁰ Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D.), University of Palermo, Palermo, Italy.
¹¹ Centre Hospitalier le Vinatier, Bron, France; INSERM U1028, CNRS UMR 5292, PSYR2 Team, Centre de recherche en Neurosciences de Lyon (CRNL), Université Lyon 1, Lyon, France.
¹² Translational Neuropsychology Lab, Department of Education and Psychology and William James Center for Research (WJCR), University of Aveiro, Campus Universitário de Santiago, Aveiro, Portugal.
¹³ Post-Graduate Program in Medical Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Brazil; Laboratory of Pain and Neuromodulation at Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil; Pain and Palliative Care Service at HCPA, Brazil; Department of Surgery, School of Medicine, UFRGS, Brazil.
¹⁴ Faculty of Medicine and Dentistry, University of Alberta, 1-002 Katz Group Centre for Pharmacy and Health Research, Edmonton, Alberta, Canada.
¹⁵ Department of Neurology, NYU Grossman School of Medicine, New York, NY, USA.
¹⁶ Psychology Clinical Neuroscience Center, Department of Psychology, The University of New Mexico, Albuquerque, NM, USA.
¹⁷ School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.
¹⁸ Neuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.
¹⁹ Research and Development, Soterix Medical Inc., New York, USA.
²⁰ Noninvasive Neuromodulation Unit, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, Bethesda, MD, USA.
²¹ Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.
²² Section of Neurosurgery, Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
²³ Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash University Department of Psychiatry, Camberwell, Victoria, Australia.
²⁴ Department of Neurology, University Medicine Greifswald, Greifswald, Germany; German Center for Neurodegenerative Diseases (DZNE), Rostock/Greifswald, Germany.
²⁵ Department of Psychiatry, University of North Carolina, Chapel Hill, NC, USA; Carolina Center for Neurostimulation, University of North Carolina, Chapel Hill, NC, USA; Neuroscience Center, University of North Carolina, Chapel Hill, NC, USA; Department of Cell Biology and Physiology, University of North Carolina, Chapel Hill, NC, USA; Department of Biomedical Engineering, University of North Carolina, Chapel Hill, NC, USA; Department of Neurology, University of North Carolina, Chapel Hill, NC, USA.
²⁶ Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, USA.
²⁷ Iranian National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran, Iran; Department of Biomedical Engineering, Shahed University, Tehran, Iran.
²⁸ Department of Psychiatry and Psychotherapy, LMU Hospital, Munich, Germany; Department of Psychological Methodology and Assessment, LMU, Munich, Germany; Hochschule Fresenius, University of Applied Sciences, Munich, Germany.
²⁹ Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.
³⁰ Department of Physiotherapy, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.
³¹ Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Science, Monash University, Melbourne, Australia.
³² Iranian National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran, Iran; Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
³³ Department of Clinical Neurosciences and Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.
³⁴ Coma Science Group, GIGA-Consciousness, GIGA Institute, University of Liège, Liege, Belgium.
³⁵ Bar Ilan University, Department of Psychology, and the Gonda Brain Research Center, Israel.
³⁶ Ybrain Corporation, Gyeonggi-do, Republic of Korea.
³⁷ INPP, Portucalense University, Porto, Portugal.
³⁸ School of Psychiatry, University of New South Wales, Sydney, NSW, Australia; Black Dog Institute, Sydney, NSW, Australia.
³⁹ Center for Mind/Brain Sciences - CIMeC, University of Trento, Rovereto, Italy.
⁴⁰ Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D.), University of Palermo, Palermo, Italy; Centre Hospitalier le Vinatier, Bron, France.
⁴¹ Applied Neuroscience Laboratory, Department of Physical Therapy, Universidade Federal de Pernambuco, UFPE, Recife, PE, Brazil; NAPeN Network (Núcleo de Assistência e Pesquisa em Neuromodulação), Brazil.
⁴² Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA 02215, USA.
⁴³ Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany; Department of Neurology, University Medical Hospital Bergmannsheil, Bochum, Germany.
⁴⁴ NAPeN Network (Núcleo de Assistência e Pesquisa em Neuromodulação), Brazil; Center for Mathematics, Computation, and Cognition, Universidade Federal do ABC, São Bernardo do Campo, Brazil; Brazilian Institute of Neuroscience and Neurotechnology (BRAINN/CEPID-FAPESP), University of Campinas, Campinas, São Paulo, Brazil.
⁴⁵ Master's and Doctoral Program in Health Sciences, Faculty of Medical Sciences, Santa Casa de São Paulo, São Paulo, Brazil; Master's and Doctoral Program in Human Movement and Rehabilitation, Evangelical University of Goiás, Anápolis, Brazil.
⁴⁶ PlatoScience ApS, Copenhagen, Denmark.
⁴⁷ Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Universidad San Ignacio de Loyola, Vicerrectorado de Investigación, Unidad de Investigación para la Generación y Síntesis de Evidencias en Salud, Lima, Peru.
⁴⁸ Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.
⁴⁹ Laboratory of Cognitive Sciences and Neuropsychopharmacology, Program of Post-Graduation in Physiological Sciences, Health Sciences Center, Federal University of Espirito Santo, Vitória, ES, Brazil.
⁵⁰ Department of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany; Medical Park Chiemseeblick, Rasthausstr. 25, 83233 Bernau-Felden, Germany.
⁵¹ Department of Neurology. Ludwig Maximilians University Munich, Klinikum Großhadern, Marchioninistr, München, Germany.
⁵² Department of Psychiatry and Psychotherapy, Tübingen Center for Mental Health (TüCMH), Neurophysiology and Interventional Neuropsychiatry, University of Tübingen, Tübingen, Germany.
⁵³ Aldo Ravelli Research Center for Neurotechnology and Experimental Neurotherapeutics, Department of Health Sciences, University of Milan, Milan, Italy.
⁵⁴ Centre for Addiction and Mental Health, Toronto, Canada; Temerty Faculty of Medicine, University of Toronto, Toronto, Canada; Toronto Dementia Research Alliance, Toronto, Canada.
⁵⁵ Service of Interdisciplinary Neuromodulation (SIN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
⁵⁶ Flow Neuroscience, Malmö, Skane Lan, Sweden.
⁵⁷ Neuroelectrics Corporation, Cambridge, MA, USA.
⁵⁸ neuroConn GmbH, Ilmenau, Germany.
⁵⁹ Iranian National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran, Iran; School of Medicine, Shahid-Sadoughi University of Medical Sciences, Yazd, Iran.
⁶⁰ Physical and Rehabilitation Medicine Institute, General Hospital, Medical School of the University of Sao Paulo, São Paulo, Brazil.
⁶¹ Coma Science Group, GIGA-Consciousness & Centre du Cerveau, University and University Hospital of Liège, Liège, Belgium.
⁶² Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Service of Interdisciplinary Neuromodulation (SIN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
⁶³ Department of Head and Skin, Ghent University Hospital, Ghent University, Ghent, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium.
⁶⁴ Lab for Clinical & Integrative Neuroscience, Trinity College of Neuroscience, Trinity College Dublin, Ireland.
⁶⁵ Department of Psychiatry, National Institute of Mental Health and Neuro Sciences (NIMHANS), Bengaluru, India.
⁶⁶ Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA, USA.
⁶⁷ Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, USA; Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA; Department of Neuroscience, University of Florida, Gainesville, FL, USA.
⁶⁸ Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.

PMID: 36115809
PMCID: PMC10031774
DOI: 10.1016/j.clinph.2022.08.018

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.

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Figures

**Figure 1:**
Study workflow. First, the steering committee (SC) was formed, including prominent researchers in the field. Then, supplemented by the results of a systematic review conducted on transcranial electric stimulation (tES) trials, the SC developed the questionnaire, which was sent to all participants of the study (SC and expert panel (EP)) to answer it. Simultaneously, companies producing tES devices were contacted, based on the companies known by the SC and EP, to provide details about the available devices. Finally, the SC analyzed the data received from the questionnaire and all participants took part in reporting the results.

**Figure 2:**
Digitalization readiness of tES devices. Based on the feedback of 8 out of 13 major transcranial electric current stimulation (tES) companies, we evaluated the readiness of these systems for digital trials, considering their connectivity (capability of communicating with other devices and the Web, due to the presence of Bluetooth, Wi-Fi, 3G/4G/5G, and communication with third-party apps), methodological aspects (randomization, sham, blinding, built-in data collection, optional data collection, and optional research dashboard), parameter space flexibility (current intensity, session duration, number of sessions, electrode positioning), ecological footprint (rechargeability and replaceability of batteries, recyclability and reusability of sponges, and recyclability of devices), front-end interface (smartphone app, touch screen, device itself, no interaction), and data security (compliance to laws such as GDPR, mention of encryption and anonymization procedures, and option for not collecting sensitive data). The questionnaires and rating systems are described in the Supplementary Material - Appendix 5.

**Figure 3:**
SWOT (Strengths, Weaknesses, Opportunities, and Threats) assessment for digital tES trials. This figure depicts the ratings of 6155 participants (24 27 from the steering committee and 31 34 from the expert panel) for the ptES clinical trials strengths and opportunities (A) and threats and weaknesses (B). Each item was rated from strongly disagree to strongly agree. In ratings for the potential strengths and opportunities of tES clinical trials (A), all of the items have reached the 50% threshold of agreement (rated as either agree or strongly agree by more than 50% of the respondents). These items have also reached a more stringent threshold of 60%. However, in ratings for the potential threats and weaknesses of ptES clinical trials (B), two of the items (2.4. Skin burns as a relevant side effect, and 2.6. Higher rates of serious adverse events) did not reach the 50% threshold. Items are represented by their summary in the figure. Full text of the items is provided in Supplementary Tables 1 and 2. tDCS=transcranial direct current stimulation. ptES=portable transcranial electrical stimulation. DIY=do-it-yourself.

**Figure 4:**
Ratings for advantages and challenges of conducting tES digital trials. This figure depicts the ratings of 55 61 raters (24 34 from the steering committee and 31 27 from the expert panel) for methodological aspects of tES. Each item was rated from strongly disagree to strongly agree. In ratings for the advantages of transcranial electric stimulation (tES) digital trials from a methodological perspective, only one item (1.8. Greater internal validity) did not reach the agreement threshold of 50% (rated as either agree or strongly agree by more than 50% of the respondents). All of the other items in this category also reached a more stringent threshold of 60%. However, in ratings for challenges of tES digital trials from a methodological perspective, 9 items (2.3. Increased risk for suicidality, 2.4. Increased risk for the manic switch, 2.5. Increased risk for cognitive effects, 2.6. Increased risk for SAEs, 2.7. ptES will substitute on-site, 2.8. More dropouts, 2.9. More selection biases, 2.10. More randomization biases, and 2.13. More assessment biases) did not reach the 50% threshold of agreement. With a more stringent threshold of 60%, two additional items (2.11. More blinding biases and 2.12. More sham biases) dropped out from the agreement. Items are represented by their summary in the figure. Full texts of the items are provided in Supplementary Table 3. ptES=portable transcranial electrical stimulation. SAE=serious adverse event.

**Figure 5:**
Ratings of the tES clinical trials team features and general recommendations on digitizing tES trials. This figure depicts the ratings of 55 61 participants (24 34 from the steering committee and 31 27 from the expert panel) for the ptES clinical trials team features (A) and general recommendations for digitizing ptES clinical trials (B). Each item was rated from strongly disagree to strongly agree. In ratings for the ptES clinical trials team features (A), all of the items have reached the 50% threshold of agreement (rated as either agree or strongly agree by more than 50% of the respondents). These items have also reached a more stringent threshold of 60%. Similarly, in ratings for the general recommendations for digitizing ptES clinical trials (B), all of the items have reached the 50% threshold of agreement. However, with a more stringent threshold of 60%, one item (8. Develop methods to assess AEs) dropped out from the agreement. Items are represented by their summary in the figure. Full text of the items is provided in Supplementary Tables 4 and 5. ptES=portable transcranial electrical stimulation. AE=adverse event. SAE=serious adverse event.

**Figure 6:**
A conceptual framework for digitizing neuromodulation. As depicted on the left side of the figure, transcranial electric stimulation devices had been relatively simple, essentially using batteries connected to electrodes to deliver constant currents, and contain few (micro) electronic components. Although portable and safe, they had not been specifically designed for use outside hospital or academic center settings. New and future generations of tES will be mobile Health tES systems using digital technologies for improving health outcomes. They are and will be smaller and lighter than previous generations, possessing wireless connectivity. Such devices are already used at home and are self-delivered, usually with some degree of remote supervision. Their use will be supported by proprietary or third-party apps and wearables. Resulting together with the aforementioned concept as digitizing neuromodulation, the right side of the figure shows digital trials as clinical trials that use digital features to enhance recruitment, assessment, and data analysis and could unleash the full potential of tES regarding scalability and equity of access. There are many similarities between the assumptions of digital trials and the capabilities of mtES, which are discussed in this work. EMA=Ecological momentary assessment. mtES=mobile transcranial electrical stimulation.

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References

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Digitalized transcranial electrical stimulation: A consensus statement

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