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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.
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 VNSâ„¢) 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivistim System | Device | VNS Paired with rehabilitation movements |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Impact Scale (SIS) | Change in Stroke Impact Scale | 6 months |
| Motor Activity Log (MAL) | Change in Motor Activity Log | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Ischemic stroke patients implanted with the Vivistim System
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brent Tarver, BSEE | Contact | 8556289375 | brent.tarver@mobia.com | |
| Diana Hansen | Contact | 8556289375 | diana.hansen@mobia.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advent Health Orlando | Recruiting | Orlando | Florida | 32803 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33894832 | Background | 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. | |
| 30355189 |
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| Alexian Brothers Health System | Recruiting | Elk Grove Village | Illinois | 60007 | United States |
|
| Endeavor Health | Recruiting | Evanston | Illinois | 60201 | United States |
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| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
|
| University of Kentucky Research Foundation | Recruiting | Lexington | Kentucky | 40506 | United States |
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| Overlook Medical Center-Atlantic Health | Recruiting | Morristown | New Jersey | 07960 | United States |
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| Albany Medical College | Recruiting | Albany | New York | 12208 | United States |
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| Mt. Sinai | Recruiting | New York | New York | 10029 | United States |
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| Burke Rehabilitation Hospital | Recruiting | White Plains | New York | 10605 | United States |
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| Jefferson Health - Lehigh Valley Health Network | Recruiting | Allentown | Pennsylvania | 18103 | United States |
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| Thomas Jefferson | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| Allegheny General Hospital | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
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| Allied Services Institute of Rehabilitation Medicine | Recruiting | Scranton | Pennsylvania | 18501 | United States |
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| St David's Medical Center | Recruiting | Austin | Texas | 78701 | United States |
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| Physical Medicine and Neurotoxin Institute | Recruiting | Austin | Texas | 78759 | United States |
|
| Background |
| 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. |
| 30983963 | Background | 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. |
| 32476617 | Background | 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. |
| 26645257 | Background | 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. |
| 41988415 | Derived | Doherty 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. |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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