Clinical trial Recruiting at 16 sites Observational Ages 22 and up

Registry for patients considering Vivistim System for stroke-related arm deficits

Official title: Vivistim Registry for Paired VNS Therapy (GRASP)

Run by MicroTransponder Inc. · NCT05301140 · Data updated 2026-11-12

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 typeObservational
Ages22 Years and up
SexAll
Enrollment1000 (estimated)
SponsorMicroTransponder Inc.
Industry-sponsored
Locations16 sites (Orlando, Florida and 15 other locations)
StatusRecruiting
StartedMarch 15, 2023
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedOctober 9, 2026
Trial IDNCT05301140 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this registry are patients with upper limb deficits due to ischemic stroke who are considering the Vivistim System implant.

Probably not a fit

Patients who are not eligible for surgery will not benefit from this registry.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Advent Health Orlando
    Orlando, Florida, United States
    Recruiting
  • Alexian Brothers Health System
    Elk Grove Village, Illinois, United States
    Recruiting
  • Ascension Alexian Brothers Rehabilitation Hospital
    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
Show 10 more locations
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.