Vivistim Registry for Paired VNS Therapy (GRASP)
Sponsored by MicroTransponder Inc.
About this study
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.
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 the Vivistim System. The patient outcome registry will collect acute and long-term follow-up data on Vivistim implanted patients treated with Paired Vagus Nerve Stimulation (Paired VNS™) post-FDA appr…
Where this study is enrolling (15)
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Advent Health Orlando
Orlando, Florida
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Endeavor Health
Evanston, Illinois
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Alexian Brothers Health System
Elk Grove Village, Illinois
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University of Kansas Medical Center
Kansas City, Kansas
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University of Kentucky Research Foundation
Lexington, Kentucky
Show all 15 locations
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Overlook Medical Center-Atlantic Health
Morristown, New Jersey
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Burke Rehabilitation Hospital
White Plains, New York
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Mt. Sinai
New York, New York
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Albany Medical College
Albany, New York
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Allied Services Institute of Rehabilitation Medicine
Scranton, Pennsylvania
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Thomas Jefferson
Philadelphia, Pennsylvania
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Jefferson Health - Lehigh Valley Health Network
Allentown, Pennsylvania
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Allegheny General Hospital
Pittsburgh, Pennsylvania
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Physical Medicine and Neurotoxin Institute
Austin, Texas
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St David's Medical Center
Austin, Texas
Who can participate
Inclusion criteria
- ✓Patients implanted with the Vivistim System for upper limb deficits associated with an ischemic stroke
Exclusion criteria
- ✕Not eligible for surgery
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.