Clinical Trial

Rehabilitation Paired with VNS for Motor Function Recovery

Not Yet Recruiting
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Summary
The goal of this clinical trial is to investigate the efficacy and safety of vagus nerve stimulation (VNS) combined with rehabilitation in improving upper extremity motor function after spontaneous intracerebral hemorrhage (ICH). Researchers will evaluate the efficacy and safety of VNS by comparing the improvements of arm motor function post-ICH in the active VNS combined rehabilitation group with that in the sham VNS combined rehabilitation group (actual intensity 0 mA). 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 2025-03-19.
Trial Details
NCT Number NCT06892574
Lead Sponsor First Affiliated Hospital of Fujian Medical University
Collaborators: Beijing Pins Medical Co., Ltd
Conditions Spontaneous Intracerebral Hemorrhage, Motor Function, Upper Extremity Injury, Rehabilitation, Vagus Nerve Stimulation
Enrollment 10 participants
Start Date 2025-04-01
Primary Completion 2027-03-31 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-26