Wether VNS in Early Stage (3 Months) is Safe and More Beneficial for Post-stroke Motor Rehabilitation

Recruiting now · Phase 1

Conditions studied: Stroke, Motor Rehabilitation

In brief

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 9 months after stroke. In this randomized phase I trial, we would apply vagus nerve stimulation in an early stage (\<6 month) and observe its theraputic effect on motor function after ischaemic Stroke.We hypothesized that the early stimulation could be safe and more beneficial compared to stimulation in late stage.

Key facts

Study ID

NCT06938243

Run by

Qilu Hospital of Shandong University

People needed

100

Starts

2025-05-01

Expected to finish

2026-12-30

Last updated by the study team

2025-04-22

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4) . Severe cognitive impairment (Mini Mental State Examination < 24)

Where it is running

• Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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