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
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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RECRUITING
NA
20 participants
INTERVENTIONAL
2026-01-01
2029-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Rushna Ali
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
Countries
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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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Mayo Clinic Clinical Trials
Other Identifiers
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25-008515
Identifier Type: -
Identifier Source: org_study_id