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

NCT ID: NCT07291024

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2029-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chronic ischemic stroke

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

Group Type EXPERIMENTAL

Vagus nerve stimulation (VNS) paired with mobility training

Intervention Type 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.

Interventions

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Vagus 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Rushna Ali

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rushna Ali, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Muhib Khan, MD, MBBS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Neurosurgery Research Team

Role: CONTACT

Phone: 507-538-6563

Facility Contacts

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Neurosurgery Research Team

Role: primary

Related Links

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Other Identifiers

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25-008515

Identifier Type: -

Identifier Source: org_study_id