Vivistim Registry for Paired VNS Therapy (GRASP)

Recruiting

• Conditions: Upper Extremity Problem

• Registration Number: NCT05301140
• Lead Sponsor: MicroTransponder Inc.

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.

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 Timeline

• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-03-18
• Study First Posted: 2022-03-29
• Study Start: 2023-03-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-17
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Motor Activity Log (MAL)	6 months	Change in Motor Activity Log
Stroke Impact Scale (SIS)	6 months	Change in Stroke Impact Scale

Trial Locations

Locations (2)

Mt. Sinai; 🇺🇸 New York, New York, United States

Thomas Jefferson; 🇺🇸 Philadelphia, Pennsylvania, United States