
pmid: 36115809
pmc: PMC10031774
handle: 2434/939615 , 2268/305379 , 10773/34891 , 10807/227858 , 11572/364714 , 10447/590474 , 11379/614562 , 11328/5055 , 1959.4/unsworks_85513
pmid: 36115809
pmc: PMC10031774
handle: 2434/939615 , 2268/305379 , 10773/34891 , 10807/227858 , 11572/364714 , 10447/590474 , 11379/614562 , 11328/5055 , 1959.4/unsworks_85513
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.
Mobile Health, Consensus, [SDV]Life Sciences [q-bio], Clinical Trials and Supportive Activities, 610, 32 Biomedical and Clinical Sciences, Transcranial Direct Current Stimulation, Sciences de la santé humaine, Delphi panel; Digital health; Mobile Health; Non-invasive neuromodulation; Systematic review, anzsrc-for: 32 Biomedical and Clinical Sciences, systematic review, Clinical Research, Neurologie, Delphi panel, Humans, Non-invasive neuromodulation, Mobile health, anzsrc-for: 17 Psychology and Cognitive Sciences, Human health sciences, Transcranial Direct Current Stimulation/methods, methods [Transcranial Direct Current Stimulation], Electric Stimulation, Telemedicine, [SDV] Life Sciences [q-bio], anzsrc-for: 11 Medical and Health Sciences, Neurology, 3209 Neurosciences, Delphi panel; Non-invasive neuromodulation; Digital health; Mobile Health, Systematic review, anzsrc-for: 3209 Neurosciences, Digital Health, Generic health relevance, anzsrc-for: 09 Engineering, Digital health, ddc: ddc:610
Mobile Health, Consensus, [SDV]Life Sciences [q-bio], Clinical Trials and Supportive Activities, 610, 32 Biomedical and Clinical Sciences, Transcranial Direct Current Stimulation, Sciences de la santé humaine, Delphi panel; Digital health; Mobile Health; Non-invasive neuromodulation; Systematic review, anzsrc-for: 32 Biomedical and Clinical Sciences, systematic review, Clinical Research, Neurologie, Delphi panel, Humans, Non-invasive neuromodulation, Mobile health, anzsrc-for: 17 Psychology and Cognitive Sciences, Human health sciences, Transcranial Direct Current Stimulation/methods, methods [Transcranial Direct Current Stimulation], Electric Stimulation, Telemedicine, [SDV] Life Sciences [q-bio], anzsrc-for: 11 Medical and Health Sciences, Neurology, 3209 Neurosciences, Delphi panel; Non-invasive neuromodulation; Digital health; Mobile Health, Systematic review, anzsrc-for: 3209 Neurosciences, Digital Health, Generic health relevance, anzsrc-for: 09 Engineering, Digital health, ddc: ddc:610
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