Registry for patients considering Vivistim System for stroke-related arm deficits
Vivistim Registry for Paired VNS Therapy (GRASP)
This study is collecting information from stroke patients with arm and hand issues who are thinking about getting the Vivistim System to see how it helps them over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | MicroTransponder Inc. Industry-sponsored |
| Locations | 15 sites (Orlando, Florida and 14 other locations) |
| Trial ID | NCT05301140 on ClinicalTrials.gov |
What this trial studies
The Vivistim Registry for Paired VNS Therapy (GRASP) aims to collect real-world data on patients with arm and hand deficits following a stroke who are considering treatment with the Vivistim System. This observational registry will gather information before and after the implantation of the device, tracking patient outcomes over time. Data will be collected at multiple intervals, including baseline, 3, 6, and 12 months post-implant, and annually for up to three years. Patients who opt not to proceed with the implant can still participate as a comparison group, allowing for a comprehensive understanding of the device's impact.
Who should consider this trial
Good fit: Ideal candidates for this registry are patients with upper limb deficits due to ischemic stroke who are considering the Vivistim System implant.
Not a fit: Patients who are not eligible for surgery will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the effectiveness of the Vivistim System in improving upper limb function for stroke patients.
How similar studies have performed: While this registry approach is not novel, it builds on existing methodologies to gather real-world data on medical devices, which have shown success in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients implanted with the Vivistim System for upper limb deficits associated with an ischemic stroke Exclusion Criteria: * Not eligible for surgery
Where this trial is running
Orlando, Florida and 14 other locations
- Advent Health Orlando — Orlando, Florida, United States (Recruiting)
- Alexian Brothers Health System — Elk Grove Village, Illinois, United States (Recruiting)
- Endeavor Health — Evanston, Illinois, United States (Recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- University of Kentucky Research Foundation — Lexington, Kentucky, United States (Recruiting)
- Overlook Medical Center-Atlantic Health — Morristown, New Jersey, United States (Recruiting)
- Albany Medical College — Albany, New York, United States (Recruiting)
- Mt. Sinai — New York, New York, United States (Recruiting)
- Burke Rehabilitation Hospital — White Plains, New York, United States (Recruiting)
- Jefferson Health - Lehigh Valley Health Network — Allentown, Pennsylvania, United States (Recruiting)
- Thomas Jefferson — Philadelphia, Pennsylvania, United States (Recruiting)
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- Allied Services Institute of Rehabilitation Medicine — Scranton, Pennsylvania, United States (Recruiting)
- St David's Medical Center — Austin, Texas, United States (Recruiting)
- Physical Medicine and Neurotoxin Institute — Austin, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Brent Tarver, BSEE
- Email: brent.tarver@mobia.com
- Phone: 8556289375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.