Please use this identifier to cite or link to this item:
http://hdl.handle.net/10773/34891
Title: | Digitalized transcranial electrical stimulation: a consensus statement |
Author: | Brunoni, Andre R Ekhtiari, Hamed Antal, Andrea Auvichayapat, Paradee Baeken, Chris Benseñor, Isabela M Bikson, Marom Boggio, Paulo Borroni, Barbara Brighina, Filippo Brunelin, Erome Carvalho, Sandra Caumo, Wolnei Ciechanski, Patrick Charvet, Leigh Clark, Vincent P Kadosh, Roi Cohen Cotelli, Maria Datta, Abhishek Deng, Zhi-De Raedt, Rudi De Ridder, Dirk De Fitzgerald, Paul B Floel, Agnes Frohlich, Flavio George, Mark S Ghobadi-Azbari, Peyman Goerigk, Stephan Hamilton, Roy H Jaberzadeh, Shapour J Hoy, Kate Kidgell, Dawson J Zonoozi, Arash Khojasteh Kirton, Adam Laureys, Steven Lavidor, Michal Lee, Kiwon Leite, Jorge Lisanby, Sarah H Loo, Colleen Martin, Donel M Miniussi, Carlo Mondino, Marine Monte-Silva, Katia Morales-Quezada, Leon Nitsche, Michael A Okano, Alexandre H Oliveira, Claudia S Onarheim, Balder Pacheco-Barrios, Kevin Padberg, Frank Nakamura-Palacios, Ester M Palm, Ulrich Paulus, Walter Plewnia, Christian Priori, Alberto Rajji, Tarek K Razza, Lais B Rehn, Erik M Ruffini, Giulio Schellhorn, Klaus Zare-Bidoky, Mehran Simis, Marcel Skorupinski, Pawel Suen, Paulo Thibaut, Aurore Valiengo, Leandro C L Vanderhasselt, Marie-Anne Vanneste, Sven Venkatasubramanian, Ganesan Violante, Ines R Wexler, Anna Woods, Adam J Fregni, Felipe |
Keywords: | Mobile health Non-invasive neuromodulation Digital health Systematic review Delphi panel |
Issue Date: | Sep-2022 |
Publisher: | Elsevier |
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. |
Peer review: | yes |
URI: | http://hdl.handle.net/10773/34891 |
DOI: | 10.1016/j.clinph.2022.08.018 |
ISSN: | 1388-2457 |
Appears in Collections: | DEP - Artigos |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
Preprint.pdf | 1.02 MB | Adobe PDF | View/Open |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.