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Clinical Trials in the USA / NCT05301140
Recruiting Observational

Vivistim Registry for Paired VNS Therapy (GRASP)

NCT05301140 · tracked via the Priya Life Science USA tracker
Sponsor
MicroTransponder Inc
Phase
Observational
Started
2023-03-15
Last updated
2026-10-09

Condition(s) studied

Upper Extremity Problem

Investigational drug(s) / intervention(s)

Vivistim System

Vivistim System: VNS Paired with rehabilitation movements

Study 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.

Eligibility

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients implanted with the Vivistim System for upper limb deficits associated with an ischemic stroke Exclusion Criteria: * Not eligible for surgery

Primary outcome measure(s)

  • Fugl Meyer Assessment (FM-A) — 6 months
    Change in Fugl Meyer Assessment score
  • Wolf Motor Function Test (WMFT) — 6 months
    Change in Wolf Motor Function Test score

Trial sites (16)

FacilityCityRegionStatus
Advent Health Orlando Orlando Florida Recruiting
Alexian Brothers Health System Elk Grove Village Illinois Recruiting
Ascension Alexian Brothers Rehabilitation Hospital Elk Grove Village Illinois Recruiting
Endeavor Health Evanston Illinois Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
University of Kentucky Research Foundation Lexington Kentucky Recruiting
Overlook Medical Center-Atlantic Health Morristown New Jersey Recruiting
Albany Medical College Albany New York Recruiting
Mt. Sinai New York New York Recruiting
Burke Rehabilitation Hospital White Plains New York Recruiting
Jefferson Health - Lehigh Valley Health Network Allentown Pennsylvania Recruiting
Thomas Jefferson Philadelphia Pennsylvania Recruiting
Allegheny General Hospital Pittsburgh Pennsylvania Recruiting
Allied Services Institute of Rehabilitation Medicine Scranton Pennsylvania Recruiting
St David's Medical Center Austin Texas Recruiting
Physical Medicine and Neurotoxin Institute Austin Texas Recruiting

More MicroTransponder Inc. trials in the USA

VNS-REHAB At-Home - Post-Market Study for Using the Vivistim System® at Home Active, not recruiting

Other trials for the same condition

VNS-REHAB At-Home - Post-Market Study for Using the Vivistim System® at Home Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05301140 on ClinicalTrials.gov ↗ ← All trials in the USA