Acupuncture for poststroke hemiplegia focusing on cerebral bilateral connections: study protocol for a randomised controlled neuroimaging trial

Introduction Acupuncture is safe and effective for improving the motor function of poststroke hemiplegic patients, but there still exists a certain gap between clinical practice and understanding its neural mechanisms. The cerebral functional reconstruction after unilateral motor pathway injury exhi...

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Main Authors: Yue Wang, Hua Zhang, Xiao Han, Lan Jiang, Hualei Geng, Mengxin Lu, Zhongming Du, Pei Chen, Lixin Tang, Zhongjian Tan, Yihuai Zou
Format: Article
Language:English
Published: BMJ Publishing Group 2020-04-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/10/4/e034548.full
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author Yue Wang
Hua Zhang
Xiao Han
Lan Jiang
Hualei Geng
Mengxin Lu
Zhongming Du
Pei Chen
Lixin Tang
Zhongjian Tan
Yihuai Zou
author_facet Yue Wang
Hua Zhang
Xiao Han
Lan Jiang
Hualei Geng
Mengxin Lu
Zhongming Du
Pei Chen
Lixin Tang
Zhongjian Tan
Yihuai Zou
author_sort Yue Wang
collection DOAJ
description Introduction Acupuncture is safe and effective for improving the motor function of poststroke hemiplegic patients, but there still exists a certain gap between clinical practice and understanding its neural mechanisms. The cerebral functional reconstruction after unilateral motor pathway injury exhibits a bilateral tendency, however current studies seldom pay attention to it. Hence, based on cerebral bilateral connections, the underlying mechanism of acupuncture in stroke rehabilitation remains an area for further research. The results of this study will increase our understanding of acupuncture-induced motor recovery in patients who had suffered a stroke and demonstrate the differences in brain response and clinical assessments.Methods and analysis This is a single-centre, randomised controlled, paralleled neuroimaging trial, with patients and outcome assessors blinded. Thirty patients who had a stroke with motor dysfunction meeting the inclusion criteria will be randomly assigned (2:1) to receive either 10 sessions true or sham acupoints treatments (five sessions per week for 2 weeks). All the participants will receive conventional standard medical care and rehabilitation. Motor function assessments and neuroimaging scanning will be conducted before and after the entire acupuncture treatment. The clinical and neuroimaging data will be analysed, respectively. The voxel-mirrored homotopic connectivity will be the primary outcome and the primary effect indicator. The secondary outcomes comprise clinical evaluations and neuroimaging assessments, which include Fugl-Meyer Assessment, the National Institutes of Health Stroke Scale, fractional anisotropy and gray matter volume. The Needle Sensation Assessment Scale is an additional outcome. The correlation analysis will be explored between the neuroimaging indicators, clinical motor assessments and needle sensation.Ethics and dissemination The protocol has been approved by the ethics committee of Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (DZMEC-KY-2018-04). The results of the neuroimaging trial will be disseminated through peer-reviewed publications and conferences.Trial registration number Chinese Clinical Trials Registry (ChiCTR 1800016263).
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spelling doaj-art-89d27710d9ff46b4a7a00ca875caf2902024-12-03T18:10:08ZengBMJ Publishing GroupBMJ Open2044-60552020-04-0110410.1136/bmjopen-2019-034548Acupuncture for poststroke hemiplegia focusing on cerebral bilateral connections: study protocol for a randomised controlled neuroimaging trialYue Wang0Hua Zhang1Xiao Han2Lan Jiang3Hualei Geng4Mengxin Lu5Zhongming Du6Pei Chen7Lixin Tang8Zhongjian Tan9Yihuai Zou101 Molecular and Systems Biology, Dartmouth College Geisel School of Medicine, Hanover, New Hampshire, USADepartment of Neurology, Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Molecular and Cellular Biology, Baylor College of Medicine, Houston, Texas, USA1 Key Laboratory of Modem Teaching Technology Ministry of Education, Shaanxi Normal University, Xi`an, Shaanxi, ChinaDepartment of Neurology, Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Neurology, Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Neurology, Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, Chinapostdoctoral fellowDepartment of Acupuncture, Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Radiology, Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Neurology, Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, ChinaIntroduction Acupuncture is safe and effective for improving the motor function of poststroke hemiplegic patients, but there still exists a certain gap between clinical practice and understanding its neural mechanisms. The cerebral functional reconstruction after unilateral motor pathway injury exhibits a bilateral tendency, however current studies seldom pay attention to it. Hence, based on cerebral bilateral connections, the underlying mechanism of acupuncture in stroke rehabilitation remains an area for further research. The results of this study will increase our understanding of acupuncture-induced motor recovery in patients who had suffered a stroke and demonstrate the differences in brain response and clinical assessments.Methods and analysis This is a single-centre, randomised controlled, paralleled neuroimaging trial, with patients and outcome assessors blinded. Thirty patients who had a stroke with motor dysfunction meeting the inclusion criteria will be randomly assigned (2:1) to receive either 10 sessions true or sham acupoints treatments (five sessions per week for 2 weeks). All the participants will receive conventional standard medical care and rehabilitation. Motor function assessments and neuroimaging scanning will be conducted before and after the entire acupuncture treatment. The clinical and neuroimaging data will be analysed, respectively. The voxel-mirrored homotopic connectivity will be the primary outcome and the primary effect indicator. The secondary outcomes comprise clinical evaluations and neuroimaging assessments, which include Fugl-Meyer Assessment, the National Institutes of Health Stroke Scale, fractional anisotropy and gray matter volume. The Needle Sensation Assessment Scale is an additional outcome. The correlation analysis will be explored between the neuroimaging indicators, clinical motor assessments and needle sensation.Ethics and dissemination The protocol has been approved by the ethics committee of Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (DZMEC-KY-2018-04). The results of the neuroimaging trial will be disseminated through peer-reviewed publications and conferences.Trial registration number Chinese Clinical Trials Registry (ChiCTR 1800016263).https://bmjopen.bmj.com/content/10/4/e034548.full
spellingShingle Yue Wang
Hua Zhang
Xiao Han
Lan Jiang
Hualei Geng
Mengxin Lu
Zhongming Du
Pei Chen
Lixin Tang
Zhongjian Tan
Yihuai Zou
Acupuncture for poststroke hemiplegia focusing on cerebral bilateral connections: study protocol for a randomised controlled neuroimaging trial
BMJ Open
title Acupuncture for poststroke hemiplegia focusing on cerebral bilateral connections: study protocol for a randomised controlled neuroimaging trial
title_full Acupuncture for poststroke hemiplegia focusing on cerebral bilateral connections: study protocol for a randomised controlled neuroimaging trial
title_fullStr Acupuncture for poststroke hemiplegia focusing on cerebral bilateral connections: study protocol for a randomised controlled neuroimaging trial
title_full_unstemmed Acupuncture for poststroke hemiplegia focusing on cerebral bilateral connections: study protocol for a randomised controlled neuroimaging trial
title_short Acupuncture for poststroke hemiplegia focusing on cerebral bilateral connections: study protocol for a randomised controlled neuroimaging trial
title_sort acupuncture for poststroke hemiplegia focusing on cerebral bilateral connections study protocol for a randomised controlled neuroimaging trial
url https://bmjopen.bmj.com/content/10/4/e034548.full
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