Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 30 to 75

Vagus nerve stimulation for improving motor function after stroke

Official title: The Comparison of Safety and Treatment Results Between Early (<6 Months) and Late (> 6 Months) Vagus Stimulation for Post-stroke Motor Rehabilitation: a Randomized Clinical Trial

Run by Qilu Hospital of Shandong University · NCT06938243 · Data updated 2026-11-12

This study is testing if starting vagus nerve stimulation earlier after a stroke can help people with weak arms and hands recover better than waiting for treatment.

Quick facts

PhasePhase 1
Study typeInterventional
Ages30 Years to 75 Years
SexAll
Enrollment100 (estimated)
SponsorQilu Hospital of Shandong University
Academic / other
Locations1 site (Jinan, Shandong)
StatusRecruiting
StartedMay 1, 2025
Main results expectedMay 1, 2026
Study endsDecember 30, 2026
Registry record updatedApril 22, 2025
Trial IDNCT06938243 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals who have experienced a first-time unilateral ischemic stroke within the last 3 to 36 months and have moderate-to-severe upper-extremity hemiparesis.

Probably not a fit

Patients with excessive spasticity, severe cognitive impairment, or those who are beyond the specified time frame post-stroke may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 trial investigates the safety and efficacy of vagus nerve stimulation (VNS) applied within three months of an ischemic stroke to enhance motor rehabilitation. The study compares early VNS intervention to traditional late-stage stimulation, hypothesizing that earlier treatment may yield better outcomes for upper-extremity function. Participants will be monitored for improvements in motor abilities, specifically targeting those with moderate-to-severe hemiparesis. The trial aims to provide insights into the optimal timing for VNS in stroke rehabilitation.

Why it matters

Potential benefit: If successful, this approach could significantly improve motor recovery in stroke patients, enhancing their quality of life.

How similar studies have gone: Previous studies have shown promise in using VNS for stroke rehabilitation, but this early intervention approach is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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)

Where it's running

  • Qilu Hospital of Shandong University
    Jinan, Shandong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.