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NOT YET RECRUITING
NCT07841431
NA

Neuromodulation for Functional Recovery After Stroke

Sponsor: Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

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

OTHER

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.

OTHER

Control VNS (0.0 mA)

After implantation, participants randomized to Control VNS (0.8 mA) combined with upper limb rehabilitation.