Cargando…
Investigation of the efficacy of low-frequency repetitive transcranial magnetic stimulation on upper-limb motor recovery in subacute ischemic stroke without cortical involvement: a protocol paper for a multi-center, double-blind randomized controlled trial
INTRODUCTION: The incidence of stroke is increasing steadily due to factors such as population aging. Approximately 80% of stroke survivors have motor disorders affecting their daily lives. Repetitive transcranial magnetic stimulation (rTMS) has been reported to maximize functional recovery after st...
Autores principales: | , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10491015/ https://www.ncbi.nlm.nih.gov/pubmed/37693768 http://dx.doi.org/10.3389/fneur.2023.1216510 |
_version_ | 1785103976754053120 |
---|---|
author | Cho, Hee-Mun Cha, Seungwoo Sohn, Min Kyun Jee, Sungju Chang, Won Kee Kim, Won-Seok Paik, Nam-Jong |
author_facet | Cho, Hee-Mun Cha, Seungwoo Sohn, Min Kyun Jee, Sungju Chang, Won Kee Kim, Won-Seok Paik, Nam-Jong |
author_sort | Cho, Hee-Mun |
collection | PubMed |
description | INTRODUCTION: The incidence of stroke is increasing steadily due to factors such as population aging. Approximately 80% of stroke survivors have motor disorders affecting their daily lives. Repetitive transcranial magnetic stimulation (rTMS) has been reported to maximize functional recovery after stroke along with exercise intervention in upper limb rehabilitation treatment. However, whether rTMS affects the recovery of upper limb function in patients with stroke remains unclear. Therefore, in this trial, we will investigate the efficacy of low-frequency rTMS in patients with subcortical and brainstem ischemic stroke. METHODS: This study has been designed as a multi-center, double-blind, randomized controlled trial to compare the efficacy of low-frequency rTMS over the contralesional M1 with sham stimulation. Overall, 88 participants will be allocated to the intervention or control group in a 1:1 ratio, with stratification according to their initial upper extremity Fugl-Meyer assessment (UE-FMA) score. The participants will receive either 30 min of real rTMS (intervention group) or sham rTMS (control group), followed by 30 min of occupational therapy for 10 consecutive workdays. All the participants will receive the same amount of rehabilitation therapy throughout the intervention period. Evaluations will be performed at baseline (T0), at the end of treatment (T1), and 4 weeks after the end of treatment (T2), including the box and block test (BBT), UE-FMA, Korean version of the Modified Barthel Index, and NIH Stroke Scale scores, Finger tapping test, Brunnstrom stage, modified Ashworth scale, and grip strength. The primary outcome will be the change in the BBT score between T0 and T2. CONCLUSION: This study will provide evidence on the efficacy of low-frequency rTMS in motor function recovery of the upper limb in patients with subacute, subcortical, and brainstem ischemic stroke. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier [NCT05535504]. |
format | Online Article Text |
id | pubmed-10491015 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-104910152023-09-09 Investigation of the efficacy of low-frequency repetitive transcranial magnetic stimulation on upper-limb motor recovery in subacute ischemic stroke without cortical involvement: a protocol paper for a multi-center, double-blind randomized controlled trial Cho, Hee-Mun Cha, Seungwoo Sohn, Min Kyun Jee, Sungju Chang, Won Kee Kim, Won-Seok Paik, Nam-Jong Front Neurol Neurology INTRODUCTION: The incidence of stroke is increasing steadily due to factors such as population aging. Approximately 80% of stroke survivors have motor disorders affecting their daily lives. Repetitive transcranial magnetic stimulation (rTMS) has been reported to maximize functional recovery after stroke along with exercise intervention in upper limb rehabilitation treatment. However, whether rTMS affects the recovery of upper limb function in patients with stroke remains unclear. Therefore, in this trial, we will investigate the efficacy of low-frequency rTMS in patients with subcortical and brainstem ischemic stroke. METHODS: This study has been designed as a multi-center, double-blind, randomized controlled trial to compare the efficacy of low-frequency rTMS over the contralesional M1 with sham stimulation. Overall, 88 participants will be allocated to the intervention or control group in a 1:1 ratio, with stratification according to their initial upper extremity Fugl-Meyer assessment (UE-FMA) score. The participants will receive either 30 min of real rTMS (intervention group) or sham rTMS (control group), followed by 30 min of occupational therapy for 10 consecutive workdays. All the participants will receive the same amount of rehabilitation therapy throughout the intervention period. Evaluations will be performed at baseline (T0), at the end of treatment (T1), and 4 weeks after the end of treatment (T2), including the box and block test (BBT), UE-FMA, Korean version of the Modified Barthel Index, and NIH Stroke Scale scores, Finger tapping test, Brunnstrom stage, modified Ashworth scale, and grip strength. The primary outcome will be the change in the BBT score between T0 and T2. CONCLUSION: This study will provide evidence on the efficacy of low-frequency rTMS in motor function recovery of the upper limb in patients with subacute, subcortical, and brainstem ischemic stroke. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier [NCT05535504]. Frontiers Media S.A. 2023-08-25 /pmc/articles/PMC10491015/ /pubmed/37693768 http://dx.doi.org/10.3389/fneur.2023.1216510 Text en Copyright © 2023 Cho, Cha, Sohn, Jee, Chang, Kim and Paik. https://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 or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) 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. |
spellingShingle | Neurology Cho, Hee-Mun Cha, Seungwoo Sohn, Min Kyun Jee, Sungju Chang, Won Kee Kim, Won-Seok Paik, Nam-Jong Investigation of the efficacy of low-frequency repetitive transcranial magnetic stimulation on upper-limb motor recovery in subacute ischemic stroke without cortical involvement: a protocol paper for a multi-center, double-blind randomized controlled trial |
title | Investigation of the efficacy of low-frequency repetitive transcranial magnetic stimulation on upper-limb motor recovery in subacute ischemic stroke without cortical involvement: a protocol paper for a multi-center, double-blind randomized controlled trial |
title_full | Investigation of the efficacy of low-frequency repetitive transcranial magnetic stimulation on upper-limb motor recovery in subacute ischemic stroke without cortical involvement: a protocol paper for a multi-center, double-blind randomized controlled trial |
title_fullStr | Investigation of the efficacy of low-frequency repetitive transcranial magnetic stimulation on upper-limb motor recovery in subacute ischemic stroke without cortical involvement: a protocol paper for a multi-center, double-blind randomized controlled trial |
title_full_unstemmed | Investigation of the efficacy of low-frequency repetitive transcranial magnetic stimulation on upper-limb motor recovery in subacute ischemic stroke without cortical involvement: a protocol paper for a multi-center, double-blind randomized controlled trial |
title_short | Investigation of the efficacy of low-frequency repetitive transcranial magnetic stimulation on upper-limb motor recovery in subacute ischemic stroke without cortical involvement: a protocol paper for a multi-center, double-blind randomized controlled trial |
title_sort | investigation of the efficacy of low-frequency repetitive transcranial magnetic stimulation on upper-limb motor recovery in subacute ischemic stroke without cortical involvement: a protocol paper for a multi-center, double-blind randomized controlled trial |
topic | Neurology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10491015/ https://www.ncbi.nlm.nih.gov/pubmed/37693768 http://dx.doi.org/10.3389/fneur.2023.1216510 |
work_keys_str_mv | AT choheemun investigationoftheefficacyoflowfrequencyrepetitivetranscranialmagneticstimulationonupperlimbmotorrecoveryinsubacuteischemicstrokewithoutcorticalinvolvementaprotocolpaperforamulticenterdoubleblindrandomizedcontrolledtrial AT chaseungwoo investigationoftheefficacyoflowfrequencyrepetitivetranscranialmagneticstimulationonupperlimbmotorrecoveryinsubacuteischemicstrokewithoutcorticalinvolvementaprotocolpaperforamulticenterdoubleblindrandomizedcontrolledtrial AT sohnminkyun investigationoftheefficacyoflowfrequencyrepetitivetranscranialmagneticstimulationonupperlimbmotorrecoveryinsubacuteischemicstrokewithoutcorticalinvolvementaprotocolpaperforamulticenterdoubleblindrandomizedcontrolledtrial AT jeesungju investigationoftheefficacyoflowfrequencyrepetitivetranscranialmagneticstimulationonupperlimbmotorrecoveryinsubacuteischemicstrokewithoutcorticalinvolvementaprotocolpaperforamulticenterdoubleblindrandomizedcontrolledtrial AT changwonkee investigationoftheefficacyoflowfrequencyrepetitivetranscranialmagneticstimulationonupperlimbmotorrecoveryinsubacuteischemicstrokewithoutcorticalinvolvementaprotocolpaperforamulticenterdoubleblindrandomizedcontrolledtrial AT kimwonseok investigationoftheefficacyoflowfrequencyrepetitivetranscranialmagneticstimulationonupperlimbmotorrecoveryinsubacuteischemicstrokewithoutcorticalinvolvementaprotocolpaperforamulticenterdoubleblindrandomizedcontrolledtrial AT paiknamjong investigationoftheefficacyoflowfrequencyrepetitivetranscranialmagneticstimulationonupperlimbmotorrecoveryinsubacuteischemicstrokewithoutcorticalinvolvementaprotocolpaperforamulticenterdoubleblindrandomizedcontrolledtrial |