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

Phase 1

Recruiting

• Conditions: Stroke; Motor Rehabilitation

• Registration Number: NCT06938243
• Lead Sponsor: Qilu Hospital of Shandong University

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Study Start: 2025-05-01
• Primary Completion: 2026-05-01
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
FM-UE scores between early and late VNS	12 months after device implantation	The outcomes includes each participant's Fugl-Meyer assessment scale (FM-UE) scores for each monthly visit. FM-UE scores range from 0 to 100 and the higher scores indicated better outcome of movement.

Secondary Outcome Measures

Name	Time	Method
Arm Motor Ability Test (AMAT) between early and late VNS	12 months after device implantation	The outcomes includes each participant's the Arm Motor Ability Test (AMAT) for each monthly visit. AMAT scores range from 0 to 57 and the higher scores indicated better outcome of movement.
the Nine-Hole Peg Test between early and late VNS	12 months after device implantation	The outcomes includes each participant's the Nine-Hole Peg Test for each monthly visit.
the Bilateral Box and Block Test between early and late VNS	12 months after device implantation	The outcomes includes each participant's the Bilateral Box and Block Test for each monthly visit.
Short Form Health Survey (SF-12) between early and late VNS	12 months after device implantation	The outcomes includes each participant's score of Short Form Health Survey (SF-12) for each monthly visit. SF-12 scores range from 0 to 60 and the higher scores indicated better outcome of movement.
the EuroQol Five Dimensions Questionnaire (EQ-5D) between early and late VNS	12 months after device implantation	The outcomes includes each participant's score of the EuroQol (EQ-5D) scores range from 0 to 36 for each monthly visit.
safety and feasibility of early and late VNS	12 months after device implantation	The incidence of adverse events including hemorrhages, infections, deaths or major perioperative complications during the study

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Sichuan, China