Department of Neurology, Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, China.
The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing An Ding Hospital, Beijing, China.
BMJ Open. 2020 Apr 1;10(4):e034548. doi: 10.1136/bmjopen-2019-034548.
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.
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.
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.
Chinese Clinical Trials Registry (ChiCTR 1800016263).
针刺治疗脑卒中后偏瘫患者的运动功能安全有效，但临床实践与认识其神经机制之间仍存在一定差距。单侧运动通路损伤后的大脑功能重建表现出双侧倾向，但目前的研究很少关注这一点。因此，基于大脑的双侧连接，针刺在中风康复中的潜在机制仍需进一步研究。本研究的结果将增加我们对中风后接受针刺治疗患者的运动恢复的理解，并展示大脑反应和临床评估的差异。
这是一项单中心、随机对照、平行神经影像学试验，患者和结果评估者均设盲。符合纳入标准的 30 名脑卒中伴运动功能障碍的患者将被随机分配（2:1）接受 10 次真或假穴位治疗（每周 5 次，共 2 周）。所有参与者将接受常规标准的医疗和康复治疗。整个针刺治疗前后将进行运动功能评估和神经影像学扫描。将分别对临床和神经影像学数据进行分析。镜像同伦连接的体素将作为主要结局和主要效应指标。次要结局包括临床评估和神经影像学评估，包括 Fugl-Meyer 评估、美国国立卫生研究院卒中量表、各向异性分数和灰质体积。针感评估量表是一个附加的结局。将探索神经影像学指标、临床运动评估和针感之间的相关性分析。
该方案已获得北京中医药大学东直门医院伦理委员会（DZMEC-KY-2018-04）的批准。神经影像学试验的结果将通过同行评议的出版物和会议进行传播。
中国临床试验注册中心（ChiCTR1800016263）。
