NCT07643337
Impact of VNS With Rehab on Gait Post-Stroke
Recruiting
NAAges 22–80InterventionalTreatmentState University of New York at BuffaloInvestigator-initiated
~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
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Assaf Berger, MD · PRINCIPAL_INVESTIGATOR · University at Buffalo
Who to contact
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Do you actually qualify for this trial?
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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