Vivistim Registry for Paired VNS Therapy (GRASP)
GRASP
1 other identifier
observational
1,000
1 country
15
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2023
Longer than P75 for all trials
15 active sites
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
First Submitted
Initial submission to the registry
March 18, 2022
CompletedFirst Posted
Study publicly available on registry
March 29, 2022
CompletedStudy Start
First participant enrolled
March 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
June 29, 2026
May 1, 2026
5.8 years
March 18, 2022
June 24, 2026
Conditions
Keywords
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
VNS Paired with rehabilitation movements
Eligibility Criteria
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 (15)
Advent Health Orlando
Orlando, Florida, 32803, United States
Alexian Brothers Health System
Elk Grove Village, Illinois, 60007, United States
Endeavor Health
Evanston, Illinois, 60201, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Kentucky Research Foundation
Lexington, Kentucky, 40506, United States
Overlook Medical Center-Atlantic Health
Morristown, New Jersey, 07960, United States
Albany Medical College
Albany, New York, 12208, United States
Mt. Sinai
New York, New York, 10029, United States
Burke Rehabilitation Hospital
White Plains, New York, 10605, United States
Jefferson Health - Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Thomas Jefferson
Philadelphia, Pennsylvania, 19107, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Allied Services Institute of Rehabilitation Medicine
Scranton, Pennsylvania, 18501, United States
St David's Medical Center
Austin, Texas, 78701, United States
Physical Medicine and Neurotoxin Institute
Austin, Texas, 78759, United States
Related Publications (6)
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: 33894832BACKGROUNDKimberley 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: 30355189BACKGROUNDEngineer 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: 30983963BACKGROUNDDawson 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: 32476617BACKGROUNDDawson 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: 26645257BACKGROUNDDoherty SJ, Prudente CN, Adham Hinds R, Pierce D, Engineer ND, Carrithers J, Hansen D, Tarver WB. Study protocol for the Vivistim GRASP registry: capturing real-world outcomes of paired vagus nerve stimulation in the chronic stroke population. Front Stroke. 2026 Mar 31;5:1751659. doi: 10.3389/fstro.2026.1751659. eCollection 2026.
PMID: 41988415DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
June 29, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share