Vivistim Registry for Paired VNS Therapy (GRASP)

NCT ID: NCT05301140

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2028-12-31

Brief 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.

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.

Conditions

Upper Extremity Problem

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Vivistim System

VNS Paired with rehabilitation movements

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Not eligible for surgery

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MicroTransponder Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mt. Sinai

New York, New York, United States

Site Status: RECRUITING

Thomas Jefferson

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brent Tarver, BSEE

Role: CONTACT

brent@microtransponder.com

8556289375

Diana Hansen

Role: CONTACT

diana@microtransponder.com

8556289375

Facility Contacts

Clinical Research Coordinator

Role: primary

Karen.Gonzalez2@mountsinai.org

Therapy Manager

Role: primary

Jennifer.Rexon@jefferson.edu

References

Dawson J, Liu CY, Francisco GE, Cramer SC, Wolf SL, Dixit A, Alexander J, Ali R, Brown BL, Feng W, DeMark L, Hochberg LR, Kautz SA, Majid A, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Turner DL, Engineer ND, Kimberley TJ. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021 Apr 24;397(10284):1545-1553. doi: 10.1016/S0140-6736(21)00475-X.

Reference Type: BACKGROUND

PMID: 33894832 (View on PubMed)

Kimberley TJ, Pierce D, Prudente CN, Francisco GE, Yozbatiran N, Smith P, Tarver B, Engineer ND, Alexander Dickie D, Kline DK, Wigginton JG, Cramer SC, Dawson J. Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke. Stroke. 2018 Nov;49(11):2789-2792. doi: 10.1161/STROKEAHA.118.022279.

Reference Type: BACKGROUND

PMID: 30355189 (View on PubMed)

Engineer ND, Kimberley TJ, Prudente CN, Dawson J, Tarver WB, Hays SA. Targeted Vagus Nerve Stimulation for Rehabilitation After Stroke. Front Neurosci. 2019 Mar 29;13:280. doi: 10.3389/fnins.2019.00280. eCollection 2019.

Reference Type: BACKGROUND

PMID: 30983963 (View on PubMed)

Dawson J, Engineer ND, Prudente CN, Pierce D, Francisco G, Yozbatiran N, Tarver WB, Casavant R, Kline DK, Cramer SC, Van de Winckel A, Kimberley TJ. Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Stroke: One-Year Follow-up. Neurorehabil Neural Repair. 2020 Jul;34(7):609-615. doi: 10.1177/1545968320924361. Epub 2020 Jun 1.

Reference Type: BACKGROUND

PMID: 32476617 (View on PubMed)

Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8.

Reference Type: BACKGROUND

PMID: 26645257 (View on PubMed)

Other Identifiers

MT-St-REG or GRASP Registry

Identifier Type: -

Identifier Source: org_study_id