IntroductionAcupuncture 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 analysisThis 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 disseminationThe 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 numberChinese Clinical Trials Registry (ChiCTR 1800016263).
Background: 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 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 bilateral cerebral connections, the underlying mechanism of acupuncture in stroke rehabilitation remains research space to date. Methods: This is a single-center, randomized controlled, paralleled neuroimaging trial, with patients, outcome assessors, and data statisticians blinded. Stroke patients with motor dysfunction meeting the inclusion criteria will be randomly assigned (2:1) to receive either true acupoints treatment or sham acupoints treatment (5 sessions per week for 2 weeks). All the patients will receive conventional treatment and rehabilitation. Participants will undergo the neuroimaging scanning before and after the entire acupuncture treatment. The clinical primary outcomes are Fugl-Meyer assessments (FMA) and the National Institutes of Health stroke scales (NIHSS). The secondary outcome is Needle Sensation Assessment Scale (NSAS). The neuroimaing outcomes are voxel-mirrored homotopic connectivity (VMHC), fractional anisotropy (FA) and gray matter volume (GMV). The correlation analysis will be explored between the neuroimage indicators and clinical motor assessments. Discussion: From the perspective of bilateral connection, this trial will investigate the cerebral influence of acupuncture treatment on poststroke patients with motor dysfunction, promoting application of acupuncture in stroke rehabilitation. Trial registration: Chinese Clinical Trials Registry, ChiCTR 1800016263. Registered on 22 May, 2018.
Background Acupuncture plays a positive role in promoting the rehabilitation of post-stroke hemiplegia, but its specific central effect mechanism remains unclear. The changes of cerebral integrity, bilateral regulation and coordination are closer to the actual running state of brain after injury, while the research on bilateral cerebral reconstruction after unilateral motor pathway injury is not sufficient. The study of cerebral functional remodeling after stroke and mechanisms of acupuncture for post-stroke hemiplegia still faces many challenges. This study will explore the the underlying mechanisms of bilateral cerebral remodeling and acupuncture for post-stroke hemiplegia rehabilitation. Methods This is a single-center, cross-sectional, multimodal functional magnetic resonance imaging(fMRI) study, with participants and data analyst blinded. 24 post-stroke patients with motor dysfunction and 24 healthy subjects that meet the inclusion criteria will be recruited in this study. All the patients enrolled in this study will receive the conventional standard medical care according to their chief doctors. Clinical data including motor function scales, high-sensitivity C-reactive protein(hs-CRP), other related scales as well as fMRI imaging data will be collected at baseline and 2 weeks later. Functional connectivity(FC) is the primary and core outcome indicator of this study. Voxel-mirrored homotopic connectivity (VMHC), fractional anisotropy (FA),voxel-based morphometry (VBM), Fugl-Meyer Assessment(FMA) and hs-CRP are secondary outcome indicators. During the MRI scan, true or sham Yanglingquan(GB34) acupuncture stimulation on the left side and passive finger movement will be performed on the participants. The connection between cerebral imaging indicators and clinical indicators will be obtained by calculating the Pearson’s correlation coefficient. Discussion The results of our study will help to understand the cerebral remodeling mechanism of motor function improvement after stroke better and provide data support for the better application of acupuncture in clinical practice. Trial registration: Chinese Clinical Trial Registry (ChiCTR1900022220). Regisered on 30 March 2019. http://www.chictr.org.cn/showprojen.aspx?proj=37359
Background: 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 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 bilateral cerebral connections, the underlying mechanism of acupuncture in stroke rehabilitation remains research space to date. Methods: This is a single-center, randomized controlled, paralleled neuroimaging trial, with patients, outcome assessors, and data statisticians blinded. Stroke patients with motor dysfunction meeting the inclusion criteria will be randomly assigned (2:1) to receive either true acupoints treatment or sham acupoints treatment (5 sessions per week for 2 weeks). All the patients will receive conventional treatment and rehabilitation. Participants will undergo the neuroimaging scanning before and after the entire acupuncture treatment. The voxel-mirrored homotopic connectivity (VHMC) will be the primary outcome and the primary effect indicator. The secondary outcomes comprise clinical part and neuroimaging part, which included Fugl-Meyer assessments (FMA), the National Institutes of Health stroke scales (NIHSS), fractional anisotropy (FA) and gray matter volume (GMV). The Needle Sensation Assessment Scale (NSAS) is an additional outcome. The correlation analysis will be explored between the neuroimage indicators and clinical motor assessments. Discussion: From the perspective of bilateral connections, this trial will investigate the cerebral influence of acupuncture treatment on poststroke patients with motor dysfunction, promoting application of acupuncture in stroke rehabilitation. Trial registration: Chinese Clinical Trials Registry, ChiCTR 1800016263. Registered on 22 May, 2018. Keywords: Acupuncture, Poststroke hemiplegia, Functional magnetic resonance imaging, Diffusion tensor imaging, Cerebral mechanism, Bilateral cerebral connections
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