Using brain stimulation to improve motor function after stroke
The Comparison of Treatment Results Between Cerebellar DBS and Vagus Stimulation for Post-stroke Motor Rehabilitation: a Randomized Clinical Trial
EARLY_PHASE1 · Qilu Hospital of Shandong University · NCT06303960
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_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 | NCT06303960 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals who have suffered a first-time unilateral ischemic stroke and have persistent moderate-to-severe upper-extremity hemiparesis.
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.
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 performed: While neuromodulation techniques have been explored in other studies, this specific comparison of cerebellar deep brain stimulation and vagus nerve stimulation 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 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 this trial is running
Jinan, Shandong
- Chao Zhang — Jinan, Shandong, China (RECRUITING)
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, Hemiparesis, Cerebellar Deep Brain Stimulation, VNS, Limb Motor Function Rehabilitation