Status:
RECRUITING
Wether VNS in Early Stage (3 Months) is Safe and More Beneficial for Post-stroke Motor Rehabilitation
Lead Sponsor:
Qilu Hospital of Shandong University
Conditions:
Stroke
Motor Rehabilitation
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
Brief Summary
Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts. In previous study, Vagus nerve stimulation was constricted to patients ...
Eligibility Criteria
Inclusion
- Eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 3-36 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
- Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4) . Severe cognitive impairment (Mini Mental State Examination \< 24)
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06938243
Start Date
May 1 2025
End Date
December 30 2026
Last Update
April 22 2025
Active Locations (1)
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1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250100