Using brain stimulation to improve motor function after stroke
Official title: The Comparison of Treatment Results Between Cerebellar DBS and Vagus Stimulation for Post-stroke Motor Rehabilitation: a Randomized Clinical Trial
Run by Qilu Hospital of Shandong University · NCT06303960 · Data updated 2026-11-12
This study is testing whether brain stimulation can help people who have had a stroke improve their arm and hand movement better than another type of stimulation.
Quick facts
| Phase | Early 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 | March 15, 2024 |
| Main results expected | June 7, 2025 |
| Study ends | March 7, 2026 |
| Registry record updated | April 17, 2025 |
| Trial ID | NCT06303960 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals who have suffered a first-time unilateral ischemic stroke and have persistent moderate-to-severe upper-extremity hemiparesis.
✕Probably not a fit
Patients with excessive spasticity, severe cognitive impairment, or those who do not meet the inclusion criteria 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 interventional trial investigates the effectiveness of cerebellar deep brain stimulation compared to vagus nerve stimulation for enhancing upper-extremity motor rehabilitation in patients who have experienced a stroke. Participants will be randomly assigned to receive either bilateral or unilateral cerebellar stimulation or vagus nerve stimulation. The study focuses on individuals with moderate-to-severe hemiparesis resulting from a first-time ischemic stroke, aiming to determine which stimulation method yields better rehabilitation outcomes. The trial is designed to assess the potential benefits of neuromodulation in improving limb motor function after stroke.
Why it matters
Potential benefit: If successful, this approach could significantly enhance motor rehabilitation outcomes for stroke patients with upper-extremity impairments.
How similar studies have gone: While neuromodulation techniques have been explored in other studies, this specific comparison of cerebellar deep brain stimulation and vagus nerve stimulation 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 12-36 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
-
Chao Zhang
Jinan, Shandong, China Recruiting
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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.