RecruitingEarly Phase 1

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

China100 participantsStarted 2024-03-15

Plain-language summary

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.

Who can participate

Age range30 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

FM-UE scores between cerebellar DBS and VNS

Timeframe: 12 months after device implantation

Trial details

NCT IDNCT06303960

SponsorQilu Hospital of Shandong University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-07

View on ClinicalTrials.gov More Stroke trials