Digitalized transcranial electrical stimulation: A consensus statement.

Consensus Electric Stimulation Humans Telemedicine Transcranial Direct Current Stimulation / methods
Delphi panel Digital health Mobile Health Non-invasive neuromodulation Systematic review

Journal

Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology
ISSN: 1872-8952
Titre abrégé: Clin Neurophysiol
Pays: Netherlands
ID NLM: 100883319

Informations de publication

Date de publication:
11 2022
Historique:
received: 06 04 2022
revised: 16 08 2022
accepted: 20 08 2022
pubmed: 18 9 2022
medline: 20 10 2022
entrez: 17 9 2022
Statut: ppublish

Résumé

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. 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. 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. Panelists recognized the potential of tES for scalability, generalizability, and leverage of digital trials processes; with no consensus about aspects regarding methodological biases. 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.

Identifiants

DOI: 10.1016/j.clinph.2022.08.018 PMID: 36115809 PMC: PMC10031774
pubmed: 36115809
pii: S1388-2457(22)00871-9
doi: 10.1016/j.clinph.2022.08.018
pmc: PMC10031774
mid: NIHMS1875869
pii:
doi:

Types de publication

Journal Article Systematic Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

154-165

Subventions

Organisme : NICHD NIH HHS
ID : R01 HD082302
Pays : United States

Informations de copyright

Copyright © 2022 International Federation of Clinical Neurophysiology. All rights reserved.

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Auteurs

Andre R Brunoni (AR)

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.

Hamed Ekhtiari (H)

Laureate Institute for Brain Research (LIBR), Tulsa, OK, USA.

Andrea Antal (A)

Department of Neurology, University Medical Center Göttingen, Göttingen, Germany.

Paradee Auvichayapat (P)

Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.

Chris Baeken (C)

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.

Isabela M Benseñor (IM)

Center for Clinical and Epidemiological Research, University of São Paulo, São Paulo, Brazil.

Marom Bikson (M)

The Department of Biomedical Engineering, The City College of New York, The City University of New York, NY, USA.

Paulo Boggio (P)

Social and Cognitive Neuroscience Laboratory, Center for Biological Science and Health, Mackenzie Presbyterian University, São Paulo, Brazil.

Barbara Borroni (B)

Centre for Neurodegenerative Disorders, Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Italy.

Filippo Brighina (F)

Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D.), University of Palermo, Palermo, Italy.

Jerome Brunelin (J)

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.

Sandra Carvalho (S)

Translational Neuropsychology Lab, Department of Education and Psychology and William James Center for Research (WJCR), University of Aveiro, Campus Universitário de Santiago, Aveiro, Portugal.

Wolnei Caumo (W)

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.

Patrick Ciechanski (P)

Faculty of Medicine and Dentistry, University of Alberta, 1-002 Katz Group Centre for Pharmacy and Health Research, Edmonton, Alberta, Canada.

Leigh Charvet (L)

Department of Neurology, NYU Grossman School of Medicine, New York, NY, USA.

Vincent P Clark (VP)

Psychology Clinical Neuroscience Center, Department of Psychology, The University of New Mexico, Albuquerque, NM, USA.

Roi Cohen Kadosh (R)

School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.

Maria Cotelli (M)

Neuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.

Abhishek Datta (A)

Research and Development, Soterix Medical Inc., New York, USA.

Zhi-De Deng (ZD)

Noninvasive Neuromodulation Unit, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, Bethesda, MD, USA.

Rudi De Raedt (R)

Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.

Dirk De Ridder (D)

Section of Neurosurgery, Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.

Paul B Fitzgerald (PB)

Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash University Department of Psychiatry, Camberwell, Victoria, Australia.

Agnes Floel (A)

Department of Neurology, University Medicine Greifswald, Greifswald, Germany; German Center for Neurodegenerative Diseases (DZNE), Rostock/Greifswald, Germany.

Flavio Frohlich (F)

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.

Mark S George (MS)

Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, USA.

Peyman Ghobadi-Azbari (P)

Iranian National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran, Iran; Department of Biomedical Engineering, Shahed University, Tehran, Iran.

Stephan Goerigk (S)

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.

Roy H Hamilton (RH)

Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.

Shapour J Jaberzadeh (SJ)

Department of Physiotherapy, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.

Kate Hoy (K)

Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash University Department of Psychiatry, Camberwell, Victoria, Australia.

Dawson J Kidgell (DJ)

Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Science, Monash University, Melbourne, Australia.

Arash Khojasteh Zonoozi (AK)

Iranian National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran, Iran; Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

Adam Kirton (A)

Department of Clinical Neurosciences and Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.

Steven Laureys (S)

Coma Science Group, GIGA-Consciousness, GIGA Institute, University of Liège, Liege, Belgium.

Michal Lavidor (M)

Bar Ilan University, Department of Psychology, and the Gonda Brain Research Center, Israel.

Kiwon Lee (K)

Ybrain Corporation, Gyeonggi-do, Republic of Korea.

Jorge Leite (J)

INPP, Portucalense University, Porto, Portugal.

Sarah H Lisanby (SH)

Noninvasive Neuromodulation Unit, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, Bethesda, MD, USA.

Colleen Loo (C)

School of Psychiatry, University of New South Wales, Sydney, NSW, Australia; Black Dog Institute, Sydney, NSW, Australia.

Donel M Martin (DM)

School of Psychiatry, University of New South Wales, Sydney, NSW, Australia; Black Dog Institute, Sydney, NSW, Australia.

Carlo Miniussi (C)

Center for Mind/Brain Sciences - CIMeC, University of Trento, Rovereto, Italy.

Marine Mondino (M)

Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D.), University of Palermo, Palermo, Italy; Centre Hospitalier le Vinatier, Bron, France.

Katia Monte-Silva (K)

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.

Leon Morales-Quezada (L)

Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA 02215, USA.

Michael A Nitsche (MA)

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.

Alexandre H Okano (AH)

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.

Claudia S Oliveira (CS)

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.

Balder Onarheim (B)

PlatoScience ApS, Copenhagen, Denmark.

Kevin Pacheco-Barrios (K)

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.

Frank Padberg (F)

Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.

Ester M Nakamura-Palacios (EM)

Laboratory of Cognitive Sciences and Neuropsychopharmacology, Program of Post-Graduation in Physiological Sciences, Health Sciences Center, Federal University of Espirito Santo, Vitória, ES, Brazil.

Ulrich Palm (U)

Department of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany; Medical Park Chiemseeblick, Rasthausstr. 25, 83233 Bernau-Felden, Germany.

Walter Paulus (W)

Department of Neurology. Ludwig Maximilians University Munich, Klinikum Großhadern, Marchioninistr, München, Germany.

Christian Plewnia (C)

Department of Psychiatry and Psychotherapy, Tübingen Center for Mental Health (TüCMH), Neurophysiology and Interventional Neuropsychiatry, University of Tübingen, Tübingen, Germany.

Alberto Priori (A)

Aldo Ravelli Research Center for Neurotechnology and Experimental Neurotherapeutics, Department of Health Sciences, University of Milan, Milan, Italy.

Tarek K Rajji (TK)

Centre for Addiction and Mental Health, Toronto, Canada; Temerty Faculty of Medicine, University of Toronto, Toronto, Canada; Toronto Dementia Research Alliance, Toronto, Canada.

Lais B Razza (LB)

Service of Interdisciplinary Neuromodulation (SIN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.

Erik M Rehn (EM)

Flow Neuroscience, Malmö, Skane Lan, Sweden.

Giulio Ruffini (G)

Neuroelectrics Corporation, Cambridge, MA, USA.

Klaus Schellhorn (K)

neuroConn GmbH, Ilmenau, Germany.

Mehran Zare-Bidoky (M)

Iranian National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran, Iran; School of Medicine, Shahid-Sadoughi University of Medical Sciences, Yazd, Iran.

Marcel Simis (M)

Physical and Rehabilitation Medicine Institute, General Hospital, Medical School of the University of Sao Paulo, São Paulo, Brazil.

Pawel Skorupinski (P)

Neuroelectrics Corporation, Cambridge, MA, USA.

Paulo Suen (P)

Service of Interdisciplinary Neuromodulation (SIN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.

Aurore Thibaut (A)

Coma Science Group, GIGA-Consciousness & Centre du Cerveau, University and University Hospital of Liège, Liège, Belgium.

Leandro C L Valiengo (LCL)

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.

Marie-Anne Vanderhasselt (MA)

Department of Head and Skin, Ghent University Hospital, Ghent University, Ghent, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium.

Sven Vanneste (S)

Lab for Clinical & Integrative Neuroscience, Trinity College of Neuroscience, Trinity College Dublin, Ireland.

Ganesan Venkatasubramanian (G)

Department of Psychiatry, National Institute of Mental Health and Neuro Sciences (NIMHANS), Bengaluru, India.

Ines R Violante (IR)

School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.

Anna Wexler (A)

Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA, USA.

Adam J Woods (AJ)

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.

Felipe Fregni (F)

Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.

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Classifications MeSH

questionsmedicales.fr › Phénomènes psychologiques › Processus mentaux › Pensée (activité mentale) › Prise de décision › Consensus › Digitalized transcranial electrical...
questionsmedicales.fr › Techniques d'investigation › Stimulation physique › Stimulation électrique › Digitalized transcranial electrical...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Digitalized transcranial electrical...
questionsmedicales.fr › Administration des services de santé › Gestion des soins aux patients › Télémédecine › Digitalized transcranial electrical...
questionsmedicales.fr › Disciplines et activités comportementales › Techniques psychologiques › Électrochoc › Stimulation transcrânienne par courant continu › Digitalized transcranial electrical...