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)

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.

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Journal
Neuroprotection/Neuroprotection (Chichester, England. Print)
Published
2026-02-10
DOI
https://doi.org/10.1002/nep3.70025
Primary Topic
Vagus Nerve Stimulation Research
Type
article
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article

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)

Min Wu, X. H. Liu, Shiyi Zuo, Wen Wu et al.
Neuroprotection/Neuroprotection (Chichester, England. Print)
Vagus Nerve Stimulation Research
article

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)

Min Wu, X. H. Liu, Shiyi Zuo, Wen Wu, FuChuan Huang, Rong Xu, Bie Li, Yuting Xu, Weining Wang, Anchao Yang, Xiaoqin Sun, K. Shan Shan Shu, Tao Ding, J.J. Lu, Bo Zhang, Yong Liu, Zhiyong Wang, Jinghui Li, Min Lu, Feng Hu, Chunhua Hang, Sihao Liu, Ming Wu, Yi-Xiang Wang, Dawei Zang, Lang Shuai, Qiao Zhang, Yingchuan Chen, Yanwu Guo, Jiang Ran, Renli Qi, Zejian Chen, Lijuan Quan, Guohui Lu, Yunqian Li, Ying Mao, Fuxin Lin, Wei Wang, Hongxing Huang, Jianguo Zhang, Qingping Tang, Wei Wu, Huayang Deng, Wenjun Hong, Qi Yue, Guoxing Xu, Xiemin Liang, Zhongming Wang, Feng Wang, Zhenlan Li, Yulian Zhu, Yalan Wang, Qian Wang, Yuanxiang Lin, Ruobing Qian, Liang Chen, Liuzhong Sun
article en

Abstract

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.

Neuroprotection/Neuroprotection (Chichester, England. Print)Vol. 4(1)
Fujian Medical University (CN), Nanchang University (CN), Army Medical University (CN), Capital Medical University (CN), Jilin University (CN), Fudan University (CN), Kunming Medical University (CN), Beijing Tian Tan Hospital (CN), Second People Hospital of Hunan (CN), Nanjing Drum Tower Hospital (CN), First Affiliated Hospital of Kunming Medical University (CN), Zhujiang Hospital (CN), First Affiliated Hospital of Fujian Medical University (CN), First Hospital of Jilin University (CN), Anhui Provincial Hospital (CN), Riverside Hospital of Guangxi Zhuang Autonomous Region (CN), Huashan Hospital (CN), Tongji Hospital (CN), First Affiliated Hospital of Nanchang University (CN), Huazhong University of Science and Technology (CN)
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