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

Abstract

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).

Acupuncture Alters Brain’s Dynamic Functional Network Connectivity in Stroke Patients with Motor Dysfunction: A Randomised Controlled Neuroimaging Trial

“…The trial was registered in the Chinese Clinical Trial Registry (Registration number: ChiCTR 1800016263). The study protocol had been published previously [ 30 ].…”

“…with Hemiplegia. From Traditional Chinese Medicine, Shou Zu Shi Er Zhen has the effect of harmonizing qi and blood, balancing yin and yang, harmonizing the spleen and stomach, and regulating body constituent and spirit [30,43]. Current evidence suggested that conventional treatment combined with Shou Zu Shi Er Zhen therapy is more effective in improving FMA score and lowering NIHSS score compared to conventional treatment in patients with poststroke hemiplegia, exerting the effectiveness of acupuncture [13][14][15].…”

Neuromodulatory Effect of Sensorimotor Network Functional Connectivity of Temporal Three-Needle Therapy for Ischemic Stroke Patients with Motor Dysfunction: Study Protocol for a Randomized, Patient-Assessor Blind, Controlled, Neuroimaging Trial

“…Our primary outcome will be resting-state FC measured by rs-fMRI. Because millions of voxels are used to indirectly estimate the blood oxygen level-dependent (BOLD) signal and traditional power calculations are of no significance [ 32 ], we calculated the sample size according to the relevant published articles. Previous rs-fMRI study of the acupuncture mechanisms in stroke had a sample size of 20 cases for the healthy control group [ 33 ].…”

The underlying mechanisms of bilateral cerebral remodeling and acupuncture for rehabilitation after post-stroke hemiplegia: study protocol for a cross-sectional multimodal fMRI trial

“…The evaluation results of NSAS can be used as a reference index of acupuncture e cacy [39]. The NSAS will be evaluated after each fMRI by the acupuncturist.…”