Consensus; Electric Stimulation; Humans; Telemedicine; Transcranial Direct Current Stimulation/methods; Delphi panel; Digital health; Mobile Health; Non-invasive neuromodulation; Systematic review
Abstract :
[en] 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.
Research Center/Unit :
CHU de Liège-Centre du Cerveau² - ULiège
Disciplines :
Neurology
Author, co-author :
Brunoni, Andre R; Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de
Ekhtiari, Hamed; Laureate Institute for Brain Research (LIBR), Tulsa, OK, USA.
Antal, Andrea; Department of Neurology, University Medical Center Göttingen, Göttingen, Germany.
Auvichayapat, Paradee; Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen,
Baeken, Chris; Vrije Universiteit Brussel (VUB): Department of Psychiatry University Hospital
Benseñor, Isabela M; Center for Clinical and Epidemiological Research, University of São Paulo, São
Bikson, Marom; The Department of Biomedical Engineering, The City College of New York, The City
Boggio, Paulo; Social and Cognitive Neuroscience Laboratory, Center for Biological Science and
Borroni, Barbara; Centre for Neurodegenerative Disorders, Neurology Unit, Department of Clinical
Brighina, Filippo; Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D.),
Brunelin, Jerome; Centre Hospitalier le Vinatier, Bron, France, INSERM U1028, CNRS UMR 5292, PSYR2
Carvalho, Sandra; Translational Neuropsychology Lab, Department of Education and Psychology and
Caumo, Wolnei; Post-Graduate Program in Medical Sciences, School of Medicine, Universidade
Ciechanski, Patrick; Faculty of Medicine and Dentistry, University of Alberta, 1-002 Katz Group Centre
Charvet, Leigh; Department of Neurology, NYU Grossman School of Medicine, New York, NY, USA.
Clark, Vincent P; Psychology Clinical Neuroscience Center, Department of Psychology, The University
Cohen Kadosh, Roi; School of Psychology, Faculty of Health and Medical Sciences, University of
Cotelli, Maria; Neuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli,
Datta, Abhishek; Research and Development, Soterix Medical Inc., New York, USA.
Deng, Zhi-De; Noninvasive Neuromodulation Unit, Experimental Therapeutics & Pathophysiology
De Raedt, Rudi; Department of Experimental Clinical and Health Psychology, Ghent University,
De Ridder, Dirk; Section of Neurosurgery, Department of Surgical Sciences, Dunedin School of
Fitzgerald, Paul B; Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash
Floel, Agnes; Department of Neurology, University Medicine Greifswald, Greifswald, Germany,
Frohlich, Flavio; Department of Psychiatry, University of North Carolina, Chapel Hill, NC, USA,
George, Mark S; Department of Psychiatry, Medical University of South Carolina, Charleston, SC,
Ghobadi-Azbari, Peyman; Iranian National Center for Addiction Studies, Tehran University of Medical
Goerigk, Stephan; Department of Psychiatry and Psychotherapy, LMU Hospital, Munich, Germany,
Hamilton, Roy H; Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.
Jaberzadeh, Shapour J; Department of Physiotherapy, Faculty of Medicine, Nursing and Health Sciences,
Hoy, Kate; Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash
Kidgell, Dawson J; Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of
Zonoozi, Arash Khojasteh; Iranian National Center for Addiction Studies, Tehran University of Medical
Kirton, Adam; Department of Clinical Neurosciences and Department of Pediatrics, University of
Laureys, Steven ; Centre Hospitalier Universitaire de Liège - CHU > > Centre du Cerveau²
Lavidor, Michal; Bar Ilan University, Department of Psychology, and the Gonda Brain Research
Lee, Kiwon; Ybrain Corporation, Gyeonggi-do, Republic of Korea.
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