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Cerebellar Deep Brain Stimulation or VNS for Chronic Post-stroke Motor Rehabilitation

RecruitingEARLY Phase 1Ages 30 Years - 75 YearsAllQilu Hospital of Shandong University
NCT06303960 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts.In this open-label, randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with bilateral or unilateral stimulation. Vagus nerve stimulation was also conducted for motor function after ischaemic Stroke.We hypothesized that cerebellar stimulation was superior to vagus stimulation as the motor rehabilitation after stroke benefits from both side of cerebellum.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Bilateral Cerebellar deep brain stimulation
  • Unilateral Cerebellar deep brain stimulation
  • Vagus Nerve Stimulation
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Where

1 site
Chao Zhang
Jinan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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