Rehabilitation paired with vagus nerve stimulation for motor function of chronic ischemic stroke patients in China: Study protocol of a multicenter randomized controlled trial (Repair Study).
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Yang Anchao, Liu Yong, Huang Hongxing, Sun Xiaoqin, Zang Dawei, Lu Jun, Tang Qingping, Zhu Yulian, Yue Qi, Wang Weining, Lu Guohui, Shuai Lang, Wang Jun, Li Yunqian, Bie Li, Li Zhenlan, Xu Guoxing, Li Jinghui, Ding Tao, Guo Yanwu, Wu Wen, Xu Yuting, Lin Yuanxiang, Wang Zhiyong, Lin Fuxin, Hang Chunhua, Xu Rong, Liu Xiangyu, Hong Wenjun, Shu Kai, Lu Min, Hu Feng, Qian Ruobing, Wu Ming, Sun Liuzhong, Wu Min, Chen Yingchuan, Wang Qian, Liu Sihao, Zhang Qiao, Zuo Shiyi, Zhang Binxia, Wu Wei, Wang Zhongming, Deng Huayang, Quan Lijuan, Qi Renli, Wang Wei, Huang Fuchuan, Liang Xiemin, Wang Feng, Wang Yalan, Chen Zejian, Ran Jiang, Chen Liang, Zhang Jianguo, Mao Ying
Аннотация
METHODS: It is a multicenter, triple-blinded, randomized controlled trial conducted across 13 centers in China. Up to 99 participants with upper limb motor impairment, 9 months to 10 years post-stroke, will be enrolled. All participants will undergo VNS implantation (Model G115R/G115, PINS Medical, Beijing, China) and be randomized 2:1 by a central randomization system to active stimulation (0.8 mA) or sham stimulation (0 mA) paired with standardized upper limb rehabilitation. The blinded phase includes 6 weeks of clinical therapy (three sessions/week, 90-120 min/session, ≥300 stimulation-movement repetitions) followed by 6 weeks of home-based therapy (30 min/day). Post-unblinding, the active VNS group continues home-based therapy, while the sham group receives 6 weeks of clinic-based therapy.
DISCUSSION: The primary outcome is the between-group difference in Fugl-Meyer Assessment for Upper Extremity scores at the end of 6 weeks of clinical therapy. Secondary outcomes include additional motor, functional, and quality-of-life measures. Safety will be assessed through adverse event monitoring. The Repair Study is a multicenter randomized controlled trial targeting chronic ischemic stroke populations in developing countries. It supplements the existing clinical evidence by enrolling patients with more servere motor dysfunction and being conducted in a developing country.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT06722677.