Vagus nerve stimulation for improving motor function after stroke
Official title: 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
Run by Qilu Hospital of Shandong University · NCT06938243 · Data updated 2026-11-12
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 | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | May 1, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | April 22, 2025 |
| Trial ID | NCT06938243 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promise in using VNS for stroke rehabilitation, but this early intervention approach is relatively novel.
Who can join: the full rules
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 it's running
-
Qilu Hospital of Shandong University
Jinan, Shandong, China Recruiting
Study contacts
- Study coordinator: Chao Zhang
- Email: chao_zhang@sdu.edu.cn
- Phone: 13969007232
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Deep phenotyping to explore recovery in young adults after stroke
This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.
-
Stem cell therapy for chronic stroke recovery
This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.
-
AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals
This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.
-
Web-based therapy using action observation and mirror therapy for arm weakness after stroke
This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.
-
Remote Ischaemic Conditioning for Fatigue After Stroke 2
Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.
-
Dual-task balance training plus computer-based cognitive training after stroke
In adults who recently had a stroke, the study tests whether adding computerized cognitive exercises to balance training improves balance and other recovery outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.