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@ARTICLE{Brunoni:165244,
author = {Brunoni, Andre R and Ekhtiari, Hamed and Antal, Andrea and
Auvichayapat, Paradee and Baeken, Chris and Benseñor,
Isabela M and Bikson, Marom and Boggio, Paulo and Borroni,
Barbara and Brighina, Filippo and Brunelin, Erome and
Carvalho, Sandra and Caumo, Wolnei and Ciechanski, Patrick
and Charvet, Leigh and Clark, Vincent P and Cohen Kadosh,
Roi and Cotelli, Maria and Datta, Abhishek and Deng, Zhi-De
and De Raedt, Rudi and De Ridder, Dirk and Fitzgerald, Paul
B and Floel, Agnes and Frohlich, Flavio and George, Mark S
and Ghobadi-Azbari, Peyman and Goerigk, Stephan and
Hamilton, Roy H and Jaberzadeh, Shapour J and Hoy, Kate and
Kidgell, Dawson J and Zonoozi, Arash Khojasteh and Kirton,
Adam and Laureys, Steven and Lavidor, Michal and Lee, Kiwon
and Leite, Jorge and Lisanby, Sarah H and Loo, Colleen and
Martin, Donel M and Miniussi, Carlo and Mondino, Marine and
Monte-Silva, Katia and Morales-Quezada, Leon and Nitsche,
Michael A and Okano, Alexandre H and Oliveira, Claudia S and
Onarheim, Balder and Pacheco-Barrios, Kevin and Padberg,
Frank and Nakamura-Palacios, Ester M and Palm, Ulrich and
Paulus, Walter and Plewnia, Christian and Priori, Alberto
and Rajji, Tarek K and Razza, Lais B and Rehn, Erik M and
Ruffini, Giulio and Schellhorn, Klaus and Zare-Bidoky,
Mehran and Simis, Marcel and Skorupinski, Pawel and Suen,
Paulo and Thibaut, Aurore and Valiengo, Leandro C L and
Vanderhasselt, Marie-Anne and Vanneste, Sven and
Venkatasubramanian, Ganesan and Violante, Ines R and Wexler,
Anna and Woods, Adam J and Fregni, Felipe},
title = {{D}igitalized transcranial electrical stimulation: {A}
consensus statement.},
journal = {Clinical neurophysiology},
volume = {143},
issn = {0921-884X},
address = {Amsterdam [u.a.]},
publisher = {Elsevier Science},
reportid = {DZNE-2022-01537},
pages = {154-165},
year = {2022},
abstract = {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.},
keywords = {Consensus / Electric Stimulation / Humans / Telemedicine /
Transcranial Direct Current Stimulation: methods / Delphi
panel (Other) / Digital health (Other) / Mobile Health
(Other) / Non-invasive neuromodulation (Other) / Systematic
review (Other)},
cin = {AG Teipel},
ddc = {610},
cid = {I:(DE-2719)1510100},
pnm = {353 - Clinical and Health Care Research (POF4-353)},
pid = {G:(DE-HGF)POF4-353},
typ = {PUB:(DE-HGF)16},
pmc = {pmc:PMC10031774},
pubmed = {pmid:36115809},
doi = {10.1016/j.clinph.2022.08.018},
url = {https://pub.dzne.de/record/165244},
}