Recruiting

VNS Therapy

Sponsor:

MicroTransponder Inc.

Code:

NCT05301140

Conditions

Upper Extremity Problem

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Vivistim System

Study Details

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.

Conditions

Upper Extremity Problem

Study ID

NCT05301140

Start date

Mar 15, 2023

Status verified date

May, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Not eligible for surgery

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Vivistim System

VNS Paired with rehabilitation movements

Primary outcome measure

  • Fugl Meyer Assessment (FM-A) [ Time Frame: 6 months ]
  • Wolf Motor Function Test (WMFT) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Brent Tarver, BSEE

8556289375brent.tarver@mobia.com

Diana Hansen

8556289375diana.hansen@mobia.com

Locations

Advent Health Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

Ariana Mora

407-609-9057Ariana.Mora@adventhealth.com

Alexian Brothers Health System

Recruiting

Elk Grove Village, Illinois, United States, 60007

Contacts

Ashley Madsen

847.437.5500 x7273ashley.madsen@ascension.org

Endeavor Health

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Nancy Sola

847-570-2025nancy.sola@endeavorhealth.org

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Sasha Moores

913-945-6630smoores@kumc.edu

University of Kentucky Research Foundation

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Rachel Norris

859-218-1644rachel.norris@uky.edu

Overlook Medical Center-Atlantic Health

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Ronald Benitez

973-993-7100ronald.benitez@atlanticbrainandspine.org

Albany Medical College

Recruiting

Albany, New York, United States, 12208

Contacts

Alexandra Paul

518-262-5088paula1@amc.edu

Mt. Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Clinical Research Coordinator

Karen.Gonzalez2@mountsinai.org

Burke Rehabilitation Hospital

Recruiting

White Plains, New York, United States, 10605

Contacts

Josette Hartnett

914-597-2367johartnett@burke.org

Principal Investigator:

Jaskiran Ghuman

Jefferson Health - Lehigh Valley Health Network

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Christina Gogal, Clinical Research Coordinator

610-402-1555Christina.Gogal@jefferson.edu

Thomas Jefferson

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Nicole Gerhardt

215-503-0351Nicole.Gerhardt@jefferson.edu

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Alexander Whiting

412-523-8014alexander.whiting@ahn.org

Allied Services Institute of Rehabilitation Medicine

Recruiting

Scranton, Pennsylvania, United States, 18501

Contacts

Diana Pope Albright

570 348-1305Dpope@allied-services.org

St David's Medical Center

Recruiting

Austin, Texas, United States, 78701

Contacts

Robert Lee

Robert.Lee3@stdavids.com

Physical Medicine and Neurotoxin Institute

Recruiting

Austin, Texas, United States, 78759

Contacts

Joe Uriquidez

(512) 249-5583MD@PMNInstitute.com

More Information

Sponsor

MicroTransponder Inc.

Last update posted

Jun 29, 2026

Last verified

May, 2026

Keywords

  • Ischemic Stroke
  • Paired Vagus Nerve Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by MicroTransponder Inc. on 2026-06-29.