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

Using brain stimulation to improve motor function after stroke

Official title: The Comparison of Treatment Results Between Cerebellar DBS and Vagus Stimulation for Post-stroke Motor Rehabilitation: a Randomized Clinical Trial

Run by Qilu Hospital of Shandong University · NCT06303960 · Data updated 2026-11-12

This study is testing whether brain stimulation can help people who have had a stroke improve their arm and hand movement better than another type of stimulation.

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages30 Years to 75 Years
SexAll
Enrollment100 (estimated)
SponsorQilu Hospital of Shandong University
Academic / other
Locations1 site (Jinan, Shandong)
StatusRecruiting
StartedMarch 15, 2024
Main results expectedJune 7, 2025
Study endsMarch 7, 2026
Registry record updatedApril 17, 2025
Trial IDNCT06303960 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals who have suffered a first-time unilateral ischemic stroke and have persistent moderate-to-severe upper-extremity hemiparesis.

Probably not a fit

Patients with excessive spasticity, severe cognitive impairment, or those who do not meet the inclusion criteria 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 interventional trial investigates the effectiveness of cerebellar deep brain stimulation compared to vagus nerve stimulation for enhancing upper-extremity motor rehabilitation in patients who have experienced a stroke. Participants will be randomly assigned to receive either bilateral or unilateral cerebellar stimulation or vagus nerve stimulation. The study focuses on individuals with moderate-to-severe hemiparesis resulting from a first-time ischemic stroke, aiming to determine which stimulation method yields better rehabilitation outcomes. The trial is designed to assess the potential benefits of neuromodulation in improving limb motor function after stroke.

Why it matters

Potential benefit: If successful, this approach could significantly enhance motor rehabilitation outcomes for stroke patients with upper-extremity impairments.

How similar studies have gone: While neuromodulation techniques have been explored in other studies, this specific comparison of cerebellar deep brain stimulation and vagus nerve stimulation 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 12-36 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

  • Chao Zhang
    Jinan, Shandong, China
    Recruiting

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.