Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke
Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke
Patients (UK only) at least 6 months post stroke, with upper limb deficits, may enroll.
 Patients will be randomized to one of two groups - a group implanted with a device that
 allows pairing VNS with rehabilitation and a group that only receives rehabilitation (no
 implant). Patients have two baseline evaluations, one evaluation after implant but before
 initiation of treatment, and then six weeks of rehabilitation or rehabilitation + VNS,
 followed by post acute therapy evaluations at 1, 7, and 30 days after the 6-weeks of
 treatment. The intent is to assess safety and provide preliminary effectiveness information
 for VNS for upper limb functional improvement after stroke. Implanted patients may receive
 longer-term treatment and follow-up after the acute study.
Major Inclusion Criteria:

 1. History of unilateral supratentorial ischemic stroke that occurred at least 6 months
 prior

 2. Age > 18 years and < 80 years

 3. Right or left sided weakness of upper extremity

 Major Exclusion Criteria:

 1. Hemorrhagic stroke

 2. Any deficits in language or attention that interferes with reasonable study
 participation

 3. Presence of significant apraxia

 4. Profound Sensory loss

 5. Active major neurological or psychiatric diagnosis that would likely interfere with
 study protocol including alcohol or drug abuse