State University of New York at Buffalo
This is a prospective, double-blinded, randomized controlled study to evaluate the impact of Vagus Nerve Stimulation (VNS) therapy on lower limb function.
Stroke is a major cause of disability worldwide and currently there is a lack of effective treatments to improve functional capacity of patients with long-term disability. Vagus Nerve Stimulation (VNS) is FDA-approved for rehabilitation of upper limb deficits in patient with stroke. The device (including Vagus nerve electrodes and chest generator) is permanently implanted prior to the beginning of rehabilitation as standard of care. It is activated by patients and physical therapists during a period of 4.5 months of in-clinic and home therapy. However, so far there have been no approved neurom…
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…
Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)
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