RecruitingNot ApplicableNCT07643337

Impact of VNS With Rehab on Gait Post-Stroke

The Impact of Vagus Nerve Stimulation Paired With Rehabilitation on Lower Limb and Gait Functions After Ischemic Stroke

Sponsor

State University of New York at Buffalo

Enrollment

24 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Stroke Stroke Gait Rehabilitation Upper Limb Deficit

Summary

This is a prospective, double-blinded, randomized controlled study to evaluate the impact of Vagus Nerve Stimulation (VNS) therapy on lower limb function.

Eligibility

Min Age: 22 YearsMax Age: 80 Years

Inclusion Criteria6

Approved for Vagus Nerve Stimulation (VNS) and rehabilitation therapy
≥22 years and ≤ 80 years
Only patients who elect to undergo VNS therapy for stroke-related upper limb deficits
Residual active movement in the affected limb's thumb and other 2 fingers
Stroke-related deficits in the lower limbs and gait with a Functional Ambulation Category (FAC) ≥3
Able to follow simple instructions and independently walk short distances with or without external support or leg orthoses, but without manual contact with another person

Exclusion Criteria3

Intact lower limb functions (Fugl-Meyer score=34)
Not a candidate for VNS therapy according to FDA guidelines
Pregnant patients

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Interventions

DEVICEVagus Nerve Stimulation Therapy

Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)

Locations(1)

University at Buffalo Neurosurgery

Buffalo, New York, United States

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NCT07643337

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