Vagus Nerve Stimulation (VNS) with Mobility Training for Stroke Recovery

This study is testing a treatment called Vagus Nerve Stimulation (VNS) combined with mobility training to help people who have had an ischemic stroke (a stroke caused by a blood clot) at least six months ago. The goal is to see if this combination can improve how well you can move your legs and walk. You might be able to join if you are 18 or older, had an ischemic stroke, and have some difficulty walking. The study will look at how safe VNS and therapy are, how many people complete the study, and changes in walking ability over 12 months. This study plans to enroll 20 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
What's involved
Participants will have a 6-week in-clinic therapy phase with VNS three times a week, followed by a 6-week at-home phase with daily exercises and VNS use.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured at the beginning of the study and again at 12 months.

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NCT07291024

A Study Of Vagus Nerve Stimulation (VNS) With Mobility Training For Gait Recovery After Chronic Ischemic Stroke

Recruiting
NAAges 18+InterventionalTreatment
Mayo Clinic
~20 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:Vagus nerve stimulation (VNS) paired with mobility training

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of serious adverse events related to vagus nerve stimulation or therapy
Measured over 1 year
+2 more outcomes measured
Ischemic Stroke
1 sites across 1 states
Minnesota1
  • Rushna Ali, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
  • Muhib Khan, MD, MBBS · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

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

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.
  • Number of serious adverse events related to vagus nerve stimulation or therapy1 year

    Total number of serious adverse events reported related to vagus nerve stimulation (VNS) or mobility training

  • Number of participants to complete the study1 year

    Total number of participants to complete a minimum of 18 therapy sessions

  • Change in Instrumented Gait Assessment scoreBaseline, 12 months

    Gait speed is calculated as the predetermined distance divided by the time to walk that distance, reported in meters per second (m/s). Improvement in gait velocity is ≥0.05 m/s .