Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • 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)

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety 6-weeks No

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