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

Mayo Clinic

Status: Enrolling

Conditions: Ischemic Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07291024

25-008515

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Chronic ischemic stroke

Experimental group

Description:

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

Treatment:

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