Vagus nerve stimulation plus mobility training for walking recovery after chronic ischemic stroke
Vagus Nerve Stimulation (VNS) Paired With Mobility Training For Gait Recovery After Chronic Ischemic Stroke With Integration Of Biomarker Assessment
This trial will test whether vagus nerve stimulation paired with mobility training can help adults who had an ischemic stroke at least six months ago improve their walking speed and stability.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07291024 on ClinicalTrials.gov |
What this trial studies
The trial pairs brief vagus nerve stimulation with supervised mobility training sessions aimed at improving lower extremity function in people with chronic ischemic stroke. Eligible participants are adults at least six months post-ischemic stroke with slowed gait (under 0.8 m/s on a 10-meter walk) and able to attend in-clinic rehabilitation. Investigators will collect safety and feasibility data and measure changes in gait velocity, endurance, and functional mobility over the treatment period. The single-center study is conducted at Mayo Clinic in Rochester, Minnesota.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18 years) at least six months after an ischemic stroke who walk slower than 0.8 m/s, can attend in-clinic rehabilitation, and consent to the procedure.
Not a fit: People with intracerebral hemorrhage, significant pre-stroke disability (mRS 3–5), active psychosis or recent substance abuse, other neurological disorders affecting gait, or who cannot participate in clinic-based rehab are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could increase walking speed and improve mobility, independence, and quality of life for people with chronic ischemic stroke.
How similar studies have performed: Previous trials pairing VNS with rehabilitation have shown promising results for upper-limb recovery, but application to lower-limb gait recovery is less established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Ischemic stroke ≥6 months prior to enrollment. * Post-stroke lower extremity impairment defined as gait velocity of less than 0.8 m/s on a 10-meter walk test * Provision of informed consent Exclusion Criteria: * Intracerebral Hemorrhage * Active or prior psychosis or substance abuse within two years. * Pre-stroke modified Rankin Scale (mRS) 3-5. * Unable to participate in in-clinic rehabilitation. * Preexisting neurological disorders affecting gait and mobility, such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia, major head trauma.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Rushna Ali, MD — Mayo Clinic
- Study coordinator: Neurosurgery Research Team
- Email: heaser.olyvia@mayo.edu
- Phone: 507-538-6563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.