Vivistim Registry for Paired VNS Therapy (GRASP)
MicroTransponder Inc.
Summary
The purpose of the Vivistim Registry for Paired VNS Therapy (GRASP) is to gather real-world information on patients with arm and hand deficits post-stroke who are considering Vivistim System treatment. Before and after Vivistim System implant, patient data will be collected and reported throughout the therapy process. Physicians or sites will receive appropriate remuneration for the effort and cost involved in collecting and transmitting this data to MicroTransponder Inc.
Description
The registry is a data repository of information on patients considering implant of the Vivistim System. The Vivistim System is an FDA approved (P210007) device used to help improve upper limb motor deficits after a stroke. Most patients entered into the registry will go on to be implanted with the System although those who decide not to move forward with the implant procedure can still have data collected as a non-implant comparison group (as long as either or both FM-A / WMFT assessments were collected). The primary purpose of the registry is to provide real-world usage and outcomes data on…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients implanted with the Vivistim System for upper limb deficits associated with an ischemic stroke Exclusion Criteria: * Not eligible for surgery
Interventions
- DeviceVivistim System
VNS Paired with rehabilitation movements
Locations (15)
- Advent Health OrlandoOrlando, Florida
- Alexian Brothers Health SystemElk Grove Village, Illinois
- Endeavor HealthEvanston, Illinois
- University of Kansas Medical CenterKansas City, Kansas
- University of Kentucky Research FoundationLexington, Kentucky
- Overlook Medical Center-Atlantic HealthMorristown, New Jersey