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

NCT07291024 | Recruiting

• 1 other identifier: 25-008515
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (3)

• 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

  1 year

• Number of participants to complete the study

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

  1 year

• 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 .

  Baseline, 12 months

Study Arms (1)

Chronic ischemic stroke

EXPERIMENTAL

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

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.

Chronic ischemic stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Rushna Ali, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Muhib Khan, MD, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neurosurgery Research Team

CONTACT

507-538-6563; heaser.olyvia@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)