Vagus nerve stimulation for improving motor function after stroke
The Comparison of Safety and Treatment Results Between Early (<6 Months) and Late (> 6 Months) Vagus Stimulation for Post-stroke Motor Rehabilitation: a Randomized Clinical Trial
PHASE1 · Qilu Hospital of Shandong University · NCT06938243
This study is testing if starting vagus nerve stimulation earlier after a stroke can help people with weak arms and hands recover better than waiting for treatment.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University (other) |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06938243 on ClinicalTrials.gov |
What this trial studies
This phase 1 trial investigates the safety and efficacy of vagus nerve stimulation (VNS) applied within three months of an ischemic stroke to enhance motor rehabilitation. The study compares early VNS intervention to traditional late-stage stimulation, hypothesizing that earlier treatment may yield better outcomes for upper-extremity function. Participants will be monitored for improvements in motor abilities, specifically targeting those with moderate-to-severe hemiparesis. The trial aims to provide insights into the optimal timing for VNS in stroke rehabilitation.
Who should consider this trial
Good fit: Ideal candidates are individuals who have experienced a first-time unilateral ischemic stroke within the last 3 to 36 months and have moderate-to-severe upper-extremity hemiparesis.
Not a fit: Patients with excessive spasticity, severe cognitive impairment, or those who are beyond the specified time frame post-stroke may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve motor recovery in stroke patients, enhancing their quality of life.
How similar studies have performed: Previous studies have shown promise in using VNS for stroke rehabilitation, but this early intervention approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (RECRUITING)
Study contacts
- Study coordinator: Chao Zhang
- Email: chao_zhang@sdu.edu.cn
- Phone: 13969007232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Motor Rehabilitation, Hemiparesis, VNS, Limb Motor Function Rehabilitation