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

Last updated: April 14, 2025
Sponsor: Qilu Hospital of Shandong University
Overall Status: Active - Recruiting

Phase

1

Condition

Stroke

Cerebral Ischemia

Treatment

Vagus Nerve Stimulation

Bilateral Cerebellar deep brain stimulation

Unilateral Cerebellar deep brain stimulation

Clinical Study ID

NCT06303960
VNS or DBS for stroke
  • Ages 30-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eligible individuals suffered a first-time, unilateral, ischemic stroke in themiddle cerebral artery territory that spared the diencephalon and basal ganglia 12-36 months before surgery.

  • Individuals with persistent moderate-to-severe upper-extremity hemiparesis asdefined by an FM-UE score of ≤42

  • Sufficient upper-extremity motor ability to engage in rehabilitation (that is, ascore of ≥1 on the FM-UE elbow flexion, elbow extension or finger mass flexion orextension).

Exclusion

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)

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Vagus Nerve Stimulation
Phase: 1
Study Start date:
March 15, 2024
Estimated Completion Date:
March 07, 2026

Connect with a study center

  • Chao Zhang

    Jinan, Sichuan 250100
    China

    Active - Recruiting

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