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.
- Vivistim System Device
Other Names: VNS, vagus nerve stimulation, paired VNS Intervention Desc: The Vivistim System provides vagus nerve stimulation (VNS) with rehabilitation movements. ARM 1: Kind: Experimental Label: VNS Description: VNS (vagus nerve stimulation) paired with rehabilitation as provided by the Vivistim System.
- Rehab Only Other
Intervention Desc: Rehabilitation without device implant and VNS ARM 1: Kind: Experimental Label: Rehab Only Description: Rehabilitation only (no implant, no VNS)
- Allocation: Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
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