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)
Year: 2026
Type: article
Study design: Study Protocol
Abstract: Background: Stroke remains the leading cause of long-term disability worldwide. Approximately 60% of individuals with chronic ischemic stroke experience persistent upper limb impairment that limits daily activities. The Repair Study aims to evaluate the safety and efficacy of vagus nerve stimulation (VNS) paired with rehabilitation in patients with chronic ischemic stroke in developing countries, including those with severe upper limb dysfunction, thereby generating evidence to support broader global application. 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.
DOI: 10.1002/nep3.70025
Authors: Anchao Yang, Yong Liu, Hongxing Huang, Xiaoqin Sun, Dawei Zang, Jun Lu, Qingping Tang, Yulian Zhu, Qi Yue, Weining Wang, Guohui Lu, Lang Shuai, Jun Wang, Yunqian Li, Li Bie, Zhenlan Li, Guoxing Xu, Jinghui Li, Tao Ding, Yanwu Guo, Wen Wu, Yuting Xu, Yuanxiang Lin, Zhiyong Wang, Fuxin Lin, Chunhua Hang, Rong Xu, Xiangyu Liu, Wenjun Hong, Kai Shu, Min Lu, Feng Hu, Ruobing Qian, Ming Wu, Liuzhong Sun, Min Wu, Yingchuan Chen, Qian Wang, Sihao Liu, Qiao Zhang, Shiyi Zuo, Binxia Zhang, Wei Wu, Zhongming Wang, Huayang Deng, Lijuan Quan, Renli Qi, Wei Wang, Fuchuan Huang, Xiemin Liang, Feng Wang, Yalan Wang, Zejian Chen, Jiang Ran, Liang Chen, Jianguo Zhang, Ying Mao
Institutions: Capital Medical University, Beijing Tian Tan Hospital, Army Medical University, Second People Hospital of Hunan, Fudan University, Huashan Hospital, Kunming Medical University, First Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Nanchang University, First Hospital of Jilin University, Zhujiang Hospital, Southern Medical University, Fujian Medical University, First Affiliated Hospital of Fujian Medical University, Nanjing Drum Tower Hospital, Tongji Hospital, Huazhong University of Science and Technology, University of Science and Technology of China, Anhui Provincial Hospital
Language: English
Subfield: Rehabilitation
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,000
OpenAlex ID: W7128466344