Upper Extremity ProblemGRASPNCT05301140
Vivistim Registry for Paired VNS Therapy (GRASP)
An observational study of Upper Extremity Problem, run by MicroTransponder Inc. at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Upper Extremity Problem
- What is being tested?
- Vivistim System
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 16 sitesUnited States
- Study dates
- 15 Mar 2023to 31 Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ischemic stroke patients implanted with the Vivistim System
Who may be able to join
- Patients implanted with the Vivistim System for upper limb deficits associated with an ischemic stroke
Who cannot join
- Not eligible for surgery
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
Albany Medical College
Albany, New York, 12208
Alexandra Paul, 518-262-5088, paula1@amc.edu
- Recruiting
Jefferson Health - Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Christina Gogal, Clinical Research Coordinator, 610-402-1555, Christina.Gogal@jefferson.edu
- Recruiting
St David's Medical Center
Austin, Texas, 78701
Robert Lee, Robert.Lee3@stdavids.com
- Recruiting
Physical Medicine and Neurotoxin Institute
Austin, Texas, 78759
Joe Uriquidez, (512) 249-5583, MD@PMNInstitute.com
- Recruiting
Alexian Brothers Health System
Elk Grove Village, Illinois, 60007
Ashley Madsen, 847.437.5500 x7273, ashley.madsen@ascension.org
- Recruiting
Ascension Alexian Brothers Rehabilitation Hospital
Elk Grove Village, Illinois, 60007
Katherine Enzler, 312-238-2941, Katherine.enzler@ascension.org
- Recruiting
Endeavor Health
Evanston, Illinois, 60201
Nancy Sola, 847-570-2025, nancy.sola@endeavorhealth.org
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Sasha Moores, 913-945-6630, smoores@kumc.edu
- Recruiting
University of Kentucky Research Foundation
Lexington, Kentucky, 40506
Rachel Norris, 859-218-1644, rachel.norris@uky.edu
- Recruiting
Overlook Medical Center-Atlantic Health
Morristown, New Jersey, 07960
Ronald Benitez, 973-993-7100, ronald.benitez@atlanticbrainandspine.org
- Recruiting
Mt. Sinai
New York, New York, 10029
Clinical Research Coordinator, Karen.Gonzalez2@mountsinai.org
- Recruiting
Advent Health Orlando
Orlando, Florida, 32803
Ariana Mora, 407-609-9057, Ariana.Mora@adventhealth.com
- Recruiting
Thomas Jefferson
Philadelphia, Pennsylvania, 19107
Nicole Gerhardt, 215-503-0351, Nicole.Gerhardt@jefferson.edu
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Alexander Whiting, 412-523-8014, alexander.whiting@ahn.org
- Recruiting
Allied Services Institute of Rehabilitation Medicine
Scranton, Pennsylvania, 18501
Diana Pope Albright, 570 348-1305, Dpope@allied-services.org
- Recruiting
Burke Rehabilitation Hospital
White Plains, New York, 10605
Josette Hartnett, 914-597-2367, johartnett@burke.org
Jaskiran Ghuman
About this study
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.
Read the 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
- Being tested
- Vivistim System
- Keywords
- Ischemic Stroke, Paired Vagus Nerve Stimulation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivistim SystemDevice
VNS Paired with rehabilitation movements
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Assessment (FM-A)
Change in Fugl Meyer Assessment score
Measured: 6 months
Wolf Motor Function Test (WMFT)
Change in Wolf Motor Function Test score
Measured: 6 months
Secondary outcomes (2)
Stroke Impact Scale (SIS)
Change in Stroke Impact Scale
Measured: 6 months
Motor Activity Log (MAL)
Change in Motor Activity Log
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start15 Mar 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- MicroTransponder Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301140
- Sponsor's protocol ID
- MT-St-REG or GRASP Registry
- Acronym
- GRASP
- Status last verified
- Oct 2026
- First submitted
- 18 Mar 2022
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33894832Kimberley 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.
PubMed 30355189Engineer 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.
PubMed 30983963Dawson 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.
PubMed 32476617Dawson 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.
PubMed 26645257Doherty 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.
PubMed 41988415
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vivistim Registry for Paired VNS Therapy (GRASP)
- ClinicalTrials.gov ID
- NCT05301140
- Acronym / sponsor ID
- GRASP / MT-St-REG or GRASP Registry
- Conditions
- Upper Extremity Problem
- Keywords
- Ischemic Stroke, Paired Vagus Nerve Stimulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- MicroTransponder Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ischemic stroke patients implanted with the Vivistim System
Key inclusion criteria (1 listed)
- Patients implanted with the Vivistim System for upper limb deficits associated with an ischemic stroke
Key exclusion criteria (1 listed)
- Not eligible for surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivistim SystemVNS Paired with rehabilitation movements | Device | – |
Primary outcome
Fugl Meyer Assessment (FM-A)
Time frame: 6 months
Change in Fugl Meyer Assessment score
Wolf Motor Function Test (WMFT)
Time frame: 6 months
Change in Wolf Motor Function Test score
2 secondary outcomes
Stroke Impact Scale (SIS)
Time frame: 6 months
Motor Activity Log (MAL)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 33894832Dawson 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.
- Background: PubMed 30355189Kimberley 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.
- Background: PubMed 30983963Engineer 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.
- Background: PubMed 32476617Dawson 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.
- Background: PubMed 26645257Dawson 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.
- Derived from this study: PubMed 41988415Doherty 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Extremity Problem, run by MicroTransponder Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brent Tarver, BSEE (8556289375, brent.tarver@mobia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl Meyer Assessment (FM-A) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05301140, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.