Wether VNS in Early Stage (3 Months) is Safe and More Beneficial for Post-stroke Motor Rehabilitation

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Apr 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called vagus nerve stimulation (VNS) to help improve movement in the arm and hand for patients who have had a stroke. The trial is focusing on patients who are in the early stages of recovery, specifically within three to six months after their first stroke. The researchers believe that starting this stimulation early may be safer and more effective than starting it later, which was done in previous studies.

To be eligible for the trial, participants must have experienced a first-time stroke that affected one side of their body and must have moderate to severe difficulty using their arm and hand. They should also be able to show some movement in their arm or fingers. Participants will be closely monitored throughout the study to see how well the treatment helps improve their motor function. This trial is open to both men and women aged 18 to 80 who meet these criteria, and it's currently in the recruiting phase. If you or a loved one are interested in participating, this could be an opportunity to explore a new approach to rehabilitation after a stroke.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 3-36 months before surgery.
• • Individuals with persistent moderate-to-severe upper-extremity hemiparesis as defined by an FM-UE score of ≤42
• • Sufficient upper-extremity motor ability to engage in rehabilitation (that is, a score of ≥1 on the FM-UE elbow flexion, elbow extension or finger mass flexion or extension).
• Exclusion Criteria:
• • Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4) . Severe cognitive impairment (Mini Mental State Examination \< 24)