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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Rehabilitation for Improved Upper Limb Function After Stroke (MicroTransponder's Vivistim System)|
- Safety [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]Assessment of adverse events and serious adverse events.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
VNS (vagus nerve stimulation) paired with rehabilitation as provided by the Vivistim System.
Device: Vivistim System
The Vivistim System provides vagus nerve stimulation (VNS) with rehabilitation movements.
Other Name: VNS, vagus nerve stimulation, paired VNS
Active Comparator: Rehab Only
Rehabilitation only (no implant, no VNS)
Other: Rehab Only
Rehabilitation without device implant and VNS
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669161
|U. Glasgow / Western Infirmary|
|Glasgow, Scotland, United Kingdom|
|Principal Investigator:||Jesse Dawson, MD||U. Glasgow|