Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols

The effect of transcranial direct current stimulation (tDCS) is cumulative. Treatment protocols typically require multiple consecutive sessions spanning weeks or months. However, traveling to clinic for a tDCS session can present an obstacle to subjects and their caregivers. With modified devices an...

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Main Authors:	Charvet, Leigh E., Kasschau, Margaret, Datta, Abhishek, Knotkova, Helena, Stevens, Michael C., Alonzo, Angelo, Loo, Colleen, Krull, Kevin R., Bikson, Marom
Format:	Online
Language:	English
Published:	Frontiers Media S.A. 2015
Online Access:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4362220/

id	pubmed-4362220
recordtype	oai_dc
spelling	pubmed-43622202015-04-07 Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols Charvet, Leigh E. Kasschau, Margaret Datta, Abhishek Knotkova, Helena Stevens, Michael C. Alonzo, Angelo Loo, Colleen Krull, Kevin R. Bikson, Marom Neuroscience The effect of transcranial direct current stimulation (tDCS) is cumulative. Treatment protocols typically require multiple consecutive sessions spanning weeks or months. However, traveling to clinic for a tDCS session can present an obstacle to subjects and their caregivers. With modified devices and headgear, tDCS treatment can be administered remotely under clinical supervision, potentially enhancing recruitment, throughput, and convenience. Here we propose standards and protocols for clinical trials utilizing remotely-supervised tDCS with the goal of providing safe, reproducible and well-tolerated stimulation therapy outside of the clinic. The recommendations include: (1) training of staff in tDCS treatment and supervision; (2) assessment of the user’s capability to participate in tDCS remotely; (3) ongoing training procedures and materials including assessments of the user and/or caregiver; (4) simple and fail-safe electrode preparation techniques and tDCS headgear; (5) strict dose control for each session; (6) ongoing monitoring to quantify compliance (device preparation, electrode saturation/placement, stimulation protocol), with corresponding corrective steps as required; (7) monitoring for treatment-emergent adverse effects; (8) guidelines for discontinuation of a session and/or study participation including emergency failsafe procedures tailored to the treatment population’s level of need. These guidelines are intended to provide a minimal level of methodological rigor for clinical trials seeking to apply tDCS outside a specialized treatment center. We outline indication-specific applications (Attention Deficit Hyperactivity Disorder, Depression, Multiple Sclerosis, Palliative Care) following these recommendations that support a standardized framework for evaluating the tolerability and reproducibility of remote-supervised tDCS that, once established, will allow for translation of tDCS clinical trials to a greater size and range of patient populations. Frontiers Media S.A. 2015-03-17 /pmc/articles/PMC4362220/ /pubmed/25852494 http://dx.doi.org/10.3389/fnsys.2015.00026 Text en Copyright © 2015 Charvet, Kasschau, Datta, Knotkova, Stevens, Alonzo, Loo, Krull and Bikson. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution and reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
repository_type	Open Access Journal
institution_category	Foreign Institution
institution	US National Center for Biotechnology Information
building	NCBI PubMed
collection	Online Access
language	English
format	Online
author	Charvet, Leigh E. Kasschau, Margaret Datta, Abhishek Knotkova, Helena Stevens, Michael C. Alonzo, Angelo Loo, Colleen Krull, Kevin R. Bikson, Marom
spellingShingle	Charvet, Leigh E. Kasschau, Margaret Datta, Abhishek Knotkova, Helena Stevens, Michael C. Alonzo, Angelo Loo, Colleen Krull, Kevin R. Bikson, Marom Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols
author_facet	Charvet, Leigh E. Kasschau, Margaret Datta, Abhishek Knotkova, Helena Stevens, Michael C. Alonzo, Angelo Loo, Colleen Krull, Kevin R. Bikson, Marom
author_sort	Charvet, Leigh E.
title	Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols
title_short	Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols
title_full	Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols
title_fullStr	Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols
title_full_unstemmed	Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols
title_sort	remotely-supervised transcranial direct current stimulation (tdcs) for clinical trials: guidelines for technology and protocols
description	The effect of transcranial direct current stimulation (tDCS) is cumulative. Treatment protocols typically require multiple consecutive sessions spanning weeks or months. However, traveling to clinic for a tDCS session can present an obstacle to subjects and their caregivers. With modified devices and headgear, tDCS treatment can be administered remotely under clinical supervision, potentially enhancing recruitment, throughput, and convenience. Here we propose standards and protocols for clinical trials utilizing remotely-supervised tDCS with the goal of providing safe, reproducible and well-tolerated stimulation therapy outside of the clinic. The recommendations include: (1) training of staff in tDCS treatment and supervision; (2) assessment of the user’s capability to participate in tDCS remotely; (3) ongoing training procedures and materials including assessments of the user and/or caregiver; (4) simple and fail-safe electrode preparation techniques and tDCS headgear; (5) strict dose control for each session; (6) ongoing monitoring to quantify compliance (device preparation, electrode saturation/placement, stimulation protocol), with corresponding corrective steps as required; (7) monitoring for treatment-emergent adverse effects; (8) guidelines for discontinuation of a session and/or study participation including emergency failsafe procedures tailored to the treatment population’s level of need. These guidelines are intended to provide a minimal level of methodological rigor for clinical trials seeking to apply tDCS outside a specialized treatment center. We outline indication-specific applications (Attention Deficit Hyperactivity Disorder, Depression, Multiple Sclerosis, Palliative Care) following these recommendations that support a standardized framework for evaluating the tolerability and reproducibility of remote-supervised tDCS that, once established, will allow for translation of tDCS clinical trials to a greater size and range of patient populations.
publisher	Frontiers Media S.A.
publishDate	2015
url	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4362220/
_version_	1613199542934568960

Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols

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