RecruitingNot Applicable

Impact of VNS With Rehab on Gait Post-Stroke

United States24 participantsStarted 2026-06

Plain-language summary

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

Who can participate

Age range

22 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale

Timeframe: 90 days post-operation

Percent Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale

Timeframe: 90 days post-operation

Trial details

NCT IDNCT07643337

SponsorState University of New York at Buffalo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-15

Contact for this trial

Ellen M Carl, PhD, CCRP

716-218-1000 ecarl@ubns.com

View on ClinicalTrials.gov More Upper Limb Deficit trials

Who can participate

Age range

22 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.