NCT06938243RecruitingPhase 1
Wether VNS in Early Stage (3 Months) is Safe and More Beneficial for Post-stroke Motor Rehabilitation
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
Source: ClinicalTrials.gov · Last updated 22 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts. In previous study, Vagus nerve stimulation was constricted to patients 9 months after stroke. In this randomized phase I trial, we would apply vagus nerve stimulation in an early stage (\<6 month) and observe its theraputic effect on motor function after ischaemic Stroke.We hypothesized that the early stimulation could be safe and more beneficial compared to stimulation in late stage.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 14 Apr 2025
- Start date
- 1 May 2025
- Primary completion date
- 1 May 2026
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Stroke
- NCT number
- NCT06938243
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 100
- From 1 May 2025 to the primary completion date, 1 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4) . Severe cognitive impairment (Mini Mental State Examination \< 24)
Who the study is looking for
- 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).
Age in the registry: 30 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.