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000165244 0247_ $$2doi$$a10.1016/j.clinph.2022.08.018
000165244 0247_ $$2pmid$$apmid:36115809
000165244 0247_ $$2ISSN$$a0921-884X
000165244 0247_ $$2ISSN$$a1388-2457
000165244 0247_ $$2ISSN$$a1872-8952
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000165244 037__ $$aDZNE-2022-01537
000165244 041__ $$aEnglish
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000165244 1001_ $$aBrunoni, Andre R$$b0
000165244 245__ $$aDigitalized transcranial electrical stimulation: A consensus statement.
000165244 260__ $$aAmsterdam [u.a.]$$bElsevier Science$$c2022
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000165244 520__ $$aAlthough relatively costly and non-scalable, non-invasive neuromodulation interventions are treatment alternatives for neuropsychiatric disorders. The recent developments of highly-deployable transcranial electric stimulation (tES) systems, combined with mobile-Health technologies, could be incorporated in digital trials to overcome methodological barriers and increase equity of access. The study aims are to discuss the implementation of tES digital trials by performing a systematic scoping review and strategic process mapping, evaluate methodological aspects of tES digital trial designs, and provide Delphi-based recommendations for implementing digital trials using tES.We convened 61 highly-productive specialists and contacted 8 tES companies to assess 71 issues related to tES digitalization readiness, and processes, barriers, advantages, and opportunities for implementing tES digital trials. Delphi-based recommendations (>60% agreement) were provided.The main strengths/opportunities of tES were: (i) non-pharmacological nature (92% of agreement), safety of these techniques (80%), affordability (88%), and potential scalability (78%). As for weaknesses/threats, we listed insufficient supervision (76%) and unclear regulatory status (69%). Many issues related to methodological biases did not reach consensus. Device appraisal showed moderate digitalization readiness, with high safety and potential for trial implementation, but low connectivity.Panelists recognized the potential of tES for scalability, generalizability, and leverage of digital trials processes; with no consensus about aspects regarding methodological biases.We further propose and discuss a conceptual framework for exploiting shared aspects between mobile-Health tES technologies with digital trials methodology to drive future efforts for digitizing tES trials.
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000165244 650_7 $$2Other$$aDelphi panel
000165244 650_7 $$2Other$$aDigital health
000165244 650_7 $$2Other$$aMobile Health
000165244 650_7 $$2Other$$aNon-invasive neuromodulation
000165244 650_7 $$2Other$$aSystematic review
000165244 650_2 $$2MeSH$$aConsensus
000165244 650_2 $$2MeSH$$aElectric Stimulation
000165244 650_2 $$2MeSH$$aHumans
000165244 650_2 $$2MeSH$$aTelemedicine
000165244 650_2 $$2MeSH$$aTranscranial Direct Current Stimulation: methods
000165244 7001_ $$aEkhtiari, Hamed$$b1
000165244 7001_ $$aAntal, Andrea$$b2
000165244 7001_ $$aAuvichayapat, Paradee$$b3
000165244 7001_ $$aBaeken, Chris$$b4
000165244 7001_ $$aBenseñor, Isabela M$$b5
000165244 7001_ $$aBikson, Marom$$b6
000165244 7001_ $$aBoggio, Paulo$$b7
000165244 7001_ $$aBorroni, Barbara$$b8
000165244 7001_ $$aBrighina, Filippo$$b9
000165244 7001_ $$aBrunelin, Erome$$b10
000165244 7001_ $$aCarvalho, Sandra$$b11
000165244 7001_ $$aCaumo, Wolnei$$b12
000165244 7001_ $$aCiechanski, Patrick$$b13
000165244 7001_ $$aCharvet, Leigh$$b14
000165244 7001_ $$aClark, Vincent P$$b15
000165244 7001_ $$aCohen Kadosh, Roi$$b16
000165244 7001_ $$aCotelli, Maria$$b17
000165244 7001_ $$aDatta, Abhishek$$b18
000165244 7001_ $$aDeng, Zhi-De$$b19
000165244 7001_ $$aDe Raedt, Rudi$$b20
000165244 7001_ $$aDe Ridder, Dirk$$b21
000165244 7001_ $$aFitzgerald, Paul B$$b22
000165244 7001_ $$0P:(DE-2719)2812683$$aFloel, Agnes$$b23$$udzne
000165244 7001_ $$aFrohlich, Flavio$$b24
000165244 7001_ $$aGeorge, Mark S$$b25
000165244 7001_ $$aGhobadi-Azbari, Peyman$$b26
000165244 7001_ $$aGoerigk, Stephan$$b27
000165244 7001_ $$aHamilton, Roy H$$b28
000165244 7001_ $$aJaberzadeh, Shapour J$$b29
000165244 7001_ $$aHoy, Kate$$b30
000165244 7001_ $$aKidgell, Dawson J$$b31
000165244 7001_ $$aZonoozi, Arash Khojasteh$$b32
000165244 7001_ $$aKirton, Adam$$b33
000165244 7001_ $$aLaureys, Steven$$b34
000165244 7001_ $$aLavidor, Michal$$b35
000165244 7001_ $$aLee, Kiwon$$b36
000165244 7001_ $$aLeite, Jorge$$b37
000165244 7001_ $$aLisanby, Sarah H$$b38
000165244 7001_ $$aLoo, Colleen$$b39
000165244 7001_ $$aMartin, Donel M$$b40
000165244 7001_ $$aMiniussi, Carlo$$b41
000165244 7001_ $$aMondino, Marine$$b42
000165244 7001_ $$aMonte-Silva, Katia$$b43
000165244 7001_ $$aMorales-Quezada, Leon$$b44
000165244 7001_ $$aNitsche, Michael A$$b45
000165244 7001_ $$aOkano, Alexandre H$$b46
000165244 7001_ $$aOliveira, Claudia S$$b47
000165244 7001_ $$aOnarheim, Balder$$b48
000165244 7001_ $$aPacheco-Barrios, Kevin$$b49
000165244 7001_ $$aPadberg, Frank$$b50
000165244 7001_ $$aNakamura-Palacios, Ester M$$b51
000165244 7001_ $$aPalm, Ulrich$$b52
000165244 7001_ $$aPaulus, Walter$$b53
000165244 7001_ $$aPlewnia, Christian$$b54
000165244 7001_ $$aPriori, Alberto$$b55
000165244 7001_ $$aRajji, Tarek K$$b56
000165244 7001_ $$aRazza, Lais B$$b57
000165244 7001_ $$aRehn, Erik M$$b58
000165244 7001_ $$aRuffini, Giulio$$b59
000165244 7001_ $$aSchellhorn, Klaus$$b60
000165244 7001_ $$aZare-Bidoky, Mehran$$b61
000165244 7001_ $$aSimis, Marcel$$b62
000165244 7001_ $$aSkorupinski, Pawel$$b63
000165244 7001_ $$aSuen, Paulo$$b64
000165244 7001_ $$aThibaut, Aurore$$b65
000165244 7001_ $$aValiengo, Leandro C L$$b66
000165244 7001_ $$aVanderhasselt, Marie-Anne$$b67
000165244 7001_ $$aVanneste, Sven$$b68
000165244 7001_ $$aVenkatasubramanian, Ganesan$$b69
000165244 7001_ $$aViolante, Ines R$$b70
000165244 7001_ $$aWexler, Anna$$b71
000165244 7001_ $$aWoods, Adam J$$b72
000165244 7001_ $$aFregni, Felipe$$b73
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