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RecruitingNCT07291024Updated Feb 17, 2026

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

An interventional study of Vagus nerve stimulation (VNS) paired with mobility training in Ischemic Stroke, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Ischemic Stroke

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03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned enrollment of 20 is below the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Chronic ischemic stroke

    Participants with chronic ischemic stroke will be treated with a combination of vagus nerve stimulation and mobility training.

    Other: Vagus nerve stimulation (VNS) paired with mobility training

Interventions

  • OtherVagus nerve stimulation (VNS) paired with mobility training

    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.

06

What researchers measure

Primary outcomes

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

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

    Time frame: 1 year

  2. Number of participants to complete the study

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

    Time frame: 1 year

  3. Change in Instrumented Gait Assessment score

    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 .

    Time frame: Baseline, 12 months

07

Study locations

1 of 1 sites recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    • Neurosurgery Research Team · Contact · 507-293-1283
    • Rushna Ali, MD · Principal investigator
    • Muhib Khan, MD, MBBS · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07291024
Lead sponsor
Mayo Clinic
Responsible party
Rushna Ali (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Dec 18, 2025
Start date
Dec 3, 2025
Primary completion
Jan 1, 2029 (estimated)
Completion
Jan 1, 2029 (estimated)
Last update
Feb 17, 2026

Study contacts

Neurosurgery Research Team
Contact
heaser.olyvia@mayo.edu
507-538-6563
Rushna Ali, MD
principal investigator · Mayo Clinic
Muhib Khan, MD, MBBS
principal investigator · Mayo Clinic

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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