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Neuromodulation for Functional Recovery After Stroke
Sponsor: Xuanwu Hospital, Beijing
Summary
This study used a multicenter, double-blind, randomized controlled design. The trial protocol was jointly designed by the principal investigator and an executive committee composed of experts in functional neurosurgery, cerebrovascular disease, and rehabilitation medicine. The study enrolled patients in the subacute phase (3-6 months) after ischemic stroke with upper limb motor impairment. All patients were implanted with a vagus nerve stimulation (VNS) device and randomly assigned to an active VNS (0.8 mA) group combined with upper limb rehabilitation or a control VNS (0.0 mA) group. This study used the FMA-UE score, WMFT score, and other measures to assess changes in impairment severity. The primary endpoint was the difference in FMA-UE score between the active VNS group and the control group at the end of 6 weeks of hospital treatment. Secondary endpoints included changes from baseline in FMA-UE score and WMFT score at 90 days, among others. This study evaluates the safety and efficacy of vagus nerve stimulation for improving upper limb motor function in patients in the subacute phase after stroke, ultimately providing clinical evidence for the diagnosis and treatment of this patient population.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-10-30
Completion Date
2028-12-01
Last Updated
2026-09-25
Healthy Volunteers
No
Interventions
active VNS (0.8 mA)
After implantation, participants are randomized 1:1 to active VNS (0.8 mA) combined with upper limb rehabilitation or control VNS (0.0 mA). To reduce the risk of participants inferring treatment assignment, participants in both treatment groups receive five stimuli of decreasing intensity at the beginning of each treatment session (starting at 0.8 mA and then decreasing by 0.1 mA at each step), after which treatment is administered according to randomization.
Control VNS (0.0 mA)
After implantation, participants randomized to Control VNS (0.8 mA) combined with upper limb rehabilitation.