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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.
SUBMITTER: Brunoni AR
PROVIDER: S-EPMC10031774 | biostudies-literature | 2022 Nov
REPOSITORIES: biostudies-literature
Brunoni Andre R AR Ekhtiari Hamed H Antal Andrea A Auvichayapat Paradee P Baeken Chris C Benseñor Isabela M IM Bikson Marom M Boggio Paulo P Borroni Barbara B Brighina Filippo F Brunelin Jerome J Carvalho Sandra S Caumo Wolnei W Ciechanski Patrick P Charvet Leigh L Clark Vincent P VP Cohen Kadosh Roi R Cotelli Maria M Datta Abhishek A Deng Zhi-De ZD De Raedt Rudi R De Ridder Dirk D Fitzgerald Paul B PB Floel Agnes A Frohlich Flavio F George Mark S MS Ghobadi-Azbari Peyman P Goerigk Stephan S Hamilton Roy H RH Jaberzadeh Shapour J SJ Hoy Kate K Kidgell Dawson J DJ Zonoozi Arash Khojasteh AK Kirton Adam A Laureys Steven S Lavidor Michal M Lee Kiwon K Leite Jorge J Lisanby Sarah H SH Loo Colleen C Martin Donel M DM Miniussi Carlo C Mondino Marine M Monte-Silva Katia K Morales-Quezada Leon L Nitsche Michael A MA Okano Alexandre H AH Oliveira Claudia S CS Onarheim Balder B Pacheco-Barrios Kevin K Padberg Frank F Nakamura-Palacios Ester M EM Palm Ulrich U Paulus Walter W Plewnia Christian C Priori Alberto A Rajji Tarek K TK Razza Lais B LB Rehn Erik M EM Ruffini Giulio G Schellhorn Klaus K Zare-Bidoky Mehran M Simis Marcel M Skorupinski Pawel P Suen Paulo P Thibaut Aurore A Valiengo Leandro C L LCL Vanderhasselt Marie-Anne MA Vanneste Sven S Venkatasubramanian Ganesan G Violante Ines R IR Wexler Anna A Woods Adam J AJ Fregni Felipe F
Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology 20220905
<h4>Objective</h4>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 syste ...[more]