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, erome 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

Resultado de la investigación: Contribución a una revistaArtículorevisión exhaustiva

Resumen

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.

Idioma originalInglés
Páginas (desde-hasta)154-165
Número de páginas12
PublicaciónClinical Neurophysiology
Volumen143
DOI
EstadoPublicada - nov. 2022

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