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NCT07643337
Impact of VNS With Rehab on Gait Post-Stroke
Conditions: Upper Limb Deficit, Stroke Gait Rehabilitation, Stroke
Sex: All
Ages: 22 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: State University of New York at Buffalo
Location: University at Buffalo Neurosurgery Buffalo New York
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 Criteria
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
Source: ClinicalTrials.gov (NCT07643337). StuddyBuddy aggregates publicly available trial information.
