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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- MicroTransponder Inc.
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Safety
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •History of unilateral supratentorial ischemic stroke that occurred at least 6 months prior
- •Age > 18 years and < 80 years
- •Right or left sided weakness of upper extremity
Exclusion Criteria
- •Hemorrhagic stroke
- •Any deficits in language or attention that interferes with reasonable study participation
- •Presence of significant apraxia
- •Profound Sensory loss
- •Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including alcohol or drug abuse
Outcomes
Primary Outcomes
Safety
Time Frame: 6-weeks
Assessment of adverse events and serious adverse events.
Secondary Outcomes
No secondary outcomes reported