Actively Recruiting

Early Phase 1
Age: 30Years - 75Years
All Genders
NCT06303960

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

Led by Qilu Hospital of Shandong University · Updated on 2025-04-17

100

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 30Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Suffered a first-time, unilateral ischemic stroke in the middle cerebral artery territory 12 to 36 months before surgery, sparing the diencephalon and basal ganglia
  • Persistent moderate-to-severe upper-extremity hemiparesis with an FM-UE score of 42 or less
  • Have sufficient upper-extremity motor ability to engage in rehabilitation (score of 1 or more on FM-UE elbow flexion, elbow extension, or finger mass flexion or extension)
Not Eligible

You will not qualify if you...

  • Excessive spasticity or contracture of the upper-extremity muscles (Modified Ashworth Scale = 4)
  • Severe cognitive impairment with Mini Mental State Examination score less than 24

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chao Zhang

Jinan, Shandong, China, 250100

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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