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Effects of cerebellar transcranial direct current stimulation on upper limb motor function after stroke: study protocol for the pilot of a randomized controlled trial
BACKGROUND: Transcranial direct current stimulation (tDCS) is a technique that can noninvasively modulate neural states in a targeted brain region. As cerebellar activity levels are associated with upper limb motor improvement after stroke, the cerebellum is a plausible target of tDCS. However, the...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9748387/ https://www.ncbi.nlm.nih.gov/pubmed/36517911 http://dx.doi.org/10.1186/s40814-022-01223-9 |
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author | Yuasa, Akiko Uehara, Shintaro Ushizawa, Kazuki Toyama, Takamichi Gomez-Tames, Jose Hirata, Akimasa Otaka, Yohei |
author_facet | Yuasa, Akiko Uehara, Shintaro Ushizawa, Kazuki Toyama, Takamichi Gomez-Tames, Jose Hirata, Akimasa Otaka, Yohei |
author_sort | Yuasa, Akiko |
collection | PubMed |
description | BACKGROUND: Transcranial direct current stimulation (tDCS) is a technique that can noninvasively modulate neural states in a targeted brain region. As cerebellar activity levels are associated with upper limb motor improvement after stroke, the cerebellum is a plausible target of tDCS. However, the effect of tDCS remains unclear. Here, we designed a pilot study to assess: (1) the feasibility of a study that aims to examine the effects of cerebellar tDCS combined with an intensive rehabilitation approach based on the concept of constraint-induced movement therapy (CIMT) and (2) the preliminary outcome of the combined approach on upper limb motor function in patients with stroke in the chronic stage. METHODS: This pilot study has a double-blind randomized controlled design. Twenty-four chronic stroke patients with mild to moderate levels of upper limb motor impairment will be randomly assigned to an active or sham tDCS group. The participants will receive 20 min of active or sham tDCS to the contralesional cerebellum at the commencement of 4 h of daily intensive training, repeatedly for 5 days per week for 2 weeks. The primary outcomes are recruitment, enrollment, protocol adherence, and retention rates and measures to evaluate the feasibility of the study. The secondary outcome is upper limb motor function which will be evaluated using the Action Research Arm Test, Fugl-Meyer Assessment, for the upper extremity and the Motor Activity Log. Additionally, neurophysiological and neuroanatomical assessments of the cerebellum will be performed using transcranial magnetic stimulation and magnetic resonance imaging. These assessments will be conducted before, at the middle, and after the 2-week intervention, and finally, 1 month after the intervention. Any adverse events that occur during the study will be recorded. DISCUSSION: Cerebellar tDCS combined with intensive upper limb training may increase the gains of motor improvement when compared to the sham condition. The present study should provide valuable evidence regarding the feasibility of the design and the efficacy of cerebellar tDCS for upper limb motor function in patients with stroke before a future large trial is conducted. TRIAL REGISTRATION: This study has been registered at the Japan Registry of Clinical Trials (jRCTs042200078). Registered 17 December 2020 |
format | Online Article Text |
id | pubmed-9748387 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-97483872022-12-14 Effects of cerebellar transcranial direct current stimulation on upper limb motor function after stroke: study protocol for the pilot of a randomized controlled trial Yuasa, Akiko Uehara, Shintaro Ushizawa, Kazuki Toyama, Takamichi Gomez-Tames, Jose Hirata, Akimasa Otaka, Yohei Pilot Feasibility Stud Study Protocol BACKGROUND: Transcranial direct current stimulation (tDCS) is a technique that can noninvasively modulate neural states in a targeted brain region. As cerebellar activity levels are associated with upper limb motor improvement after stroke, the cerebellum is a plausible target of tDCS. However, the effect of tDCS remains unclear. Here, we designed a pilot study to assess: (1) the feasibility of a study that aims to examine the effects of cerebellar tDCS combined with an intensive rehabilitation approach based on the concept of constraint-induced movement therapy (CIMT) and (2) the preliminary outcome of the combined approach on upper limb motor function in patients with stroke in the chronic stage. METHODS: This pilot study has a double-blind randomized controlled design. Twenty-four chronic stroke patients with mild to moderate levels of upper limb motor impairment will be randomly assigned to an active or sham tDCS group. The participants will receive 20 min of active or sham tDCS to the contralesional cerebellum at the commencement of 4 h of daily intensive training, repeatedly for 5 days per week for 2 weeks. The primary outcomes are recruitment, enrollment, protocol adherence, and retention rates and measures to evaluate the feasibility of the study. The secondary outcome is upper limb motor function which will be evaluated using the Action Research Arm Test, Fugl-Meyer Assessment, for the upper extremity and the Motor Activity Log. Additionally, neurophysiological and neuroanatomical assessments of the cerebellum will be performed using transcranial magnetic stimulation and magnetic resonance imaging. These assessments will be conducted before, at the middle, and after the 2-week intervention, and finally, 1 month after the intervention. Any adverse events that occur during the study will be recorded. DISCUSSION: Cerebellar tDCS combined with intensive upper limb training may increase the gains of motor improvement when compared to the sham condition. The present study should provide valuable evidence regarding the feasibility of the design and the efficacy of cerebellar tDCS for upper limb motor function in patients with stroke before a future large trial is conducted. TRIAL REGISTRATION: This study has been registered at the Japan Registry of Clinical Trials (jRCTs042200078). Registered 17 December 2020 BioMed Central 2022-12-14 /pmc/articles/PMC9748387/ /pubmed/36517911 http://dx.doi.org/10.1186/s40814-022-01223-9 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Yuasa, Akiko Uehara, Shintaro Ushizawa, Kazuki Toyama, Takamichi Gomez-Tames, Jose Hirata, Akimasa Otaka, Yohei Effects of cerebellar transcranial direct current stimulation on upper limb motor function after stroke: study protocol for the pilot of a randomized controlled trial |
title | Effects of cerebellar transcranial direct current stimulation on upper limb motor function after stroke: study protocol for the pilot of a randomized controlled trial |
title_full | Effects of cerebellar transcranial direct current stimulation on upper limb motor function after stroke: study protocol for the pilot of a randomized controlled trial |
title_fullStr | Effects of cerebellar transcranial direct current stimulation on upper limb motor function after stroke: study protocol for the pilot of a randomized controlled trial |
title_full_unstemmed | Effects of cerebellar transcranial direct current stimulation on upper limb motor function after stroke: study protocol for the pilot of a randomized controlled trial |
title_short | Effects of cerebellar transcranial direct current stimulation on upper limb motor function after stroke: study protocol for the pilot of a randomized controlled trial |
title_sort | effects of cerebellar transcranial direct current stimulation on upper limb motor function after stroke: study protocol for the pilot of a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9748387/ https://www.ncbi.nlm.nih.gov/pubmed/36517911 http://dx.doi.org/10.1186/s40814-022-01223-9 |
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