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NCT Number: NCT07291024

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

The purpose of this study is to evaluate the safety, feasibility, and efficacy of vagus nerve stimulation (VNS) paired with mobility training to improve lower extremity function and gait in individuals with chronic ischemic stroke.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vagus nerve stimulation (VNS) paired with mobility training

Other

Participants will complete a 6-week in-clinic therapy phase (3 sessions per week), where a physical therapist will lead mobility training with VNS delivered via a handheld magnet. This will be followed by a 6-week at-home phase where participants continue daily exercises and VNS use, supported by weekly video calls to review at home rehabilitation activity and wearable activity monitors for remote monitoring.

Primary outcomes

  1. Number of serious adverse events related to vagus nerve stimulation or therapy

    Time frame: 1 year

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

  2. Number of participants to complete the study

    Time frame: 1 year

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

  3. Change in Instrumented Gait Assessment score

    Time frame: Baseline, 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 .

Interested in participating?

Recruiting

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Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Vagus Nerve Stimulation (VNS) Paired With Mobility Training For Gait Recovery After Chronic Ischemic Stroke With Integration Of Biomarker Assessment

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Dec 18, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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