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NCT07643337

Impact of VNS With Rehab on Gait Post-Stroke

Recruiting
NAAges 22–80InterventionalTreatment
State University of New York at Buffalo
~24 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:Vagus Nerve Stimulation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale
Measured over 90 days post-operation
+1 more outcome measured

Conditions

Upper Limb Deficit
Stroke Gait Rehabilitation
Stroke

Explore related trials

Stroke

NCT07643337

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University at Buffalo Neurosurgery

    Buffalo, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Assaf Berger, MD · PRINCIPAL_INVESTIGATOR · University at Buffalo

Who to contact

Ellen M Carl, PhD, CCRP
[email protected]
716-218-1000 · ext. 7260
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale90 days post-operation

    Absolute change in FMA-LE from baseline to 90 days

  • Percent Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale90 days post-operation

    Percent change in FMA-LE from baseline to 90 days