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Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB)

NCT03131960 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-07-20

Study results available
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Summary

This is a pivotal phase study of up to 120 subjects and 15 clinical sites. All subjects are implanted with the Vivistim System® and then randomized to either study treatment or active-control treatment. The randomization will be stratified by age (\<30, \>30) and baseline FMA UE (20 to \<35; \>35 to 50). Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation. Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.

Conditions

  • Cerebrovascular Stroke
  • Upper Extremity Paresis

Interventions

DEVICE

Paired Vagus Nerve Stimulation

Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.

OTHER

Rehabilitation

Rehabilitation movements to improve upper limb function after stroke

Sponsors & Collaborators

  • ResearchPoint Global

    collaborator OTHER

  • MicroTransponder Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2020-04-30
Completion
2022-06-30
FDA Device
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03131960 on ClinicalTrials.gov