Actively Recruiting

Phase 1
Age: 30Years - 75Years
All Genders
NCT06938243

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

Led by Qilu Hospital of Shandong University · Updated on 2025-04-22

100

Participants Needed

1

Research Sites

86 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 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 30Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • First-time, one-sided ischemic stroke in the middle cerebral artery area 3 to 36 months before surgery
  • Moderate to severe upper limb weakness with FM-UE score of 42 or less
  • Enough upper limb movement to take part in rehabilitation (score of 1 or more on FM-UE elbow flexion, extension, or finger movements)
Not Eligible

You will not qualify if you...

  • Severe stiffness or contractures in upper limb muscles (Modified Ashworth Scale = 4)
  • Severe cognitive impairment (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

Qilu Hospital of Shandong University

Jinan, Shandong, China, 250100

Actively Recruiting

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Research Team

C

Chao Zhang

CONTACT

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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