NCT05301140

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Mar 2023Dec 2028

First Submitted

Initial submission to the registry

March 18, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

October 9, 2025

Status Verified

October 1, 2025

Enrollment Period

5.8 years

First QC Date

March 18, 2022

Last Update Submit

October 7, 2025

Conditions

Upper Extremity Problem

Keywords

Ischemic StrokePaired Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (2)

  • Fugl Meyer Assessment (FM-A)

    Change in Fugl Meyer Assessment score

    6 months

  • Wolf Motor Function Test (WMFT)

    Change in Wolf Motor Function Test score

    6 months

Secondary Outcomes (2)

  • Stroke Impact Scale (SIS)

    6 months

  • Motor Activity Log (MAL)

    6 months

Interventions

Vivistim SystemDEVICE

VNS Paired with rehabilitation movements

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ischemic stroke patients implanted with the Vivistim System

You may qualify if:

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

You may not qualify if:

  • Not eligible for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mt. Sinai

New York, New York, 10029, United States

RECRUITING

Thomas Jefferson

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 33894832BACKGROUND

  • 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.

    PMID: 30355189BACKGROUND

  • 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.

    PMID: 30983963BACKGROUND

  • 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.

    PMID: 32476617BACKGROUND

  • 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.

    PMID: 26645257BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Brent Tarver, BSEE

CONTACT

8556289375brent@microtransponder.com

Diana Hansen

CONTACT

8556289375diana@microtransponder.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2022

First Posted

March 29, 2022

Study Start

March 15, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

October 9, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)