Vivistim Registry for Paired VNS Therapy (GRASP) (GRASP)

May 1, 2026 updated by: MicroTransponder Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 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 approval.

Historical and implant information as well as quality of life information will be gathered on patients who consider implant of the Vivistim® System. Data will be collected at baseline, 3, 6, and 12 months after implantation, as well as yearly thereafter for up to three (3) years post-implant. Patients who decide not to have the Vivistim System implanted can continue to have data collected for comparison purposes.

Contributing sites and physicians will have access to their own site data and can have anonymized summary analyses on all aggregated data; sites will not have access to other sites' individual level data. Physicians can then use the above information to facilitate patient selection and treatment. Publication (oral or written) of data in the registry, other than individual site data, will not be permitted without the express written advance approval of MicroTransponder, Inc. and the other physicians contributing to the dataset.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32803
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Endeavor Health
        • Contact:
          • Nancy Sola
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Recruiting
        • University of Kentucky Research Foundation
        • Contact:
    • New Jersey
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical College
        • Contact:
      • New York, New York, United States, 10029
      • White Plains, New York, United States, 10605
        • Recruiting
        • Burke Rehabilitation Hospital
        • Contact:
        • Principal Investigator:
          • Jaskiran Ghuman
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Jefferson Health - Lehigh Valley Health Network
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19107
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Contact:
      • Scranton, Pennsylvania, United States, 18501
        • Recruiting
        • Allied Services Institute of Rehabilitation Medicine
        • Contact:
    • Texas
      • Austin, Texas, United States, 78701
      • Austin, Texas, United States, 78759
        • Recruiting
        • Physical Medicine and Neurotoxin Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Ischemic stroke patients implanted with the Vivistim System

Description

Inclusion Criteria:

  • Patients implanted with the Vivistim System for upper limb deficits associated with an ischemic stroke

Exclusion Criteria:

  • Not eligible for surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl Meyer Assessment (FM-A)
Time Frame: 6 months
Change in Fugl Meyer Assessment score
6 months
Wolf Motor Function Test (WMFT)
Time Frame: 6 months
Change in Wolf Motor Function Test score
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Impact Scale (SIS)
Time Frame: 6 months
Change in Stroke Impact Scale
6 months
Motor Activity Log (MAL)
Time Frame: 6 months
Change in Motor Activity Log
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroTransponder Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-St-REG or GRASP Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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