Effects of cerebellar transcranial direct current stimulation on upper limb motor function after stroke: study protocol for the pilot of a randomized controlled trial
Abstract 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. Howev...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-12-01
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| Series: | Pilot and Feasibility Studies |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40814-022-01223-9 |
| _version_ | 1798004967360954368 |
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| author | Akiko Yuasa Shintaro Uehara Kazuki Ushizawa Takamichi Toyama Jose Gomez-Tames Akimasa Hirata Yohei Otaka |
| author_facet | Akiko Yuasa Shintaro Uehara Kazuki Ushizawa Takamichi Toyama Jose Gomez-Tames Akimasa Hirata Yohei Otaka |
| author_sort | Akiko Yuasa |
| collection | DOAJ |
| description | Abstract 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 |
| first_indexed | 2024-04-11T12:31:52Z |
| format | Article |
| id | doaj.art-011faf8085da49179a211ca0235c2fd6 |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-04-11T12:31:52Z |
| publishDate | 2022-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-011faf8085da49179a211ca0235c2fd62022-12-22T04:23:43ZengBMCPilot and Feasibility Studies2055-57842022-12-018111310.1186/s40814-022-01223-9Effects of cerebellar transcranial direct current stimulation on upper limb motor function after stroke: study protocol for the pilot of a randomized controlled trialAkiko Yuasa0Shintaro Uehara1Kazuki Ushizawa2Takamichi Toyama3Jose Gomez-Tames4Akimasa Hirata5Yohei Otaka6Department of Rehabilitation Medicine I, Fujita Health University School of MedicineFaculty of Rehabilitation, Fujita Health University School of Health SciencesDepartment of Rehabilitation Medicine I, Fujita Health University School of MedicineDepartment of Rehabilitation Medicine I, Fujita Health University School of MedicineDepartment of Electrical and Mechanical Engineering, Nagoya Institute of TechnologyDepartment of Electrical and Mechanical Engineering, Nagoya Institute of TechnologyDepartment of Rehabilitation Medicine I, Fujita Health University School of MedicineAbstract 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 2020https://doi.org/10.1186/s40814-022-01223-9Transcranial direct current stimulation (tDCS)StrokeConstraint-induced movement therapy (CIMT)Cerebellum |
| spellingShingle | Akiko Yuasa Shintaro Uehara Kazuki Ushizawa Takamichi Toyama Jose Gomez-Tames Akimasa Hirata Yohei Otaka Effects of cerebellar transcranial direct current stimulation on upper limb motor function after stroke: study protocol for the pilot of a randomized controlled trial Pilot and Feasibility Studies Transcranial direct current stimulation (tDCS) Stroke Constraint-induced movement therapy (CIMT) Cerebellum |
| 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 | Transcranial direct current stimulation (tDCS) Stroke Constraint-induced movement therapy (CIMT) Cerebellum |
| url | https://doi.org/10.1186/s40814-022-01223-9 |
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