Clinical Trial

A Trial of Rehabilitation Paired with VNS for Motor Function in Patients with Stroke (Repair Study)

Recruiting
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Record status
This record was last updated December 10, 2024 (before its estimated August 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to investigate the efficacy and safety of vagus nerve stimulation (VNS) paired with rehabilitation for enhancing upper extremity motor function after ischemic stroke. Researchers will compare the outcomes of active VNS paired with rehabilitation against sham VNS (the actual intensity is 0 mA) also paired with rehabilitation, in order to assess improvements in arm motor function post-stroke. Participants in this study will undergo a surgical procedure to implant the VNS system and will subsequently recieve a 6 weeks in-clinic therapy, followed by an additional 6 weeks home exercise. During the final 6 weeks, participants will either recieve in-clinic therapy or maintain their home exercise, depending on their assigned group.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-12-04.
Trial Details
NCT Number NCT06722677
Lead Sponsor Beijing Pins Medical Co., Ltd
Conditions Ischemic Stroke, Upper Extremity Paresis
Enrollment 99 participants
Start Date 2024-11-19
Primary Completion 2025-08 (estimated)
Study Completion 2025-11 (estimated)
Updated on ClinicalTrials.gov 2024-12-10