CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 108 enrolled
Drug / intervention
Paired Vagus Nerve Stimulation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03131960
NCT03131960N/ACompleted
CompareCT.gov

A Pivotal Randomized Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function After Stroke (VNS-REHAB)

MicroTransponder Inc.·interventional·Posted Apr 27, 2017·Updated Jul 20, 2022

In Brief

A clinical study evaluating Paired Vagus Nerve Stimulation and Rehabilitation for Cerebrovascular Stroke and Upper Extremity Paresis. Completed, enrolled 108 participants across 20 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCerebrovascular Stroke, Upper Extremity Paresis
CountriesUnited Kingdom, United States
CollaboratorsResearchPoint Global

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 27, 2017
Enrollment StartJul 1, 2017
Primary CompletionApr 30, 2020
Study CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.2 years ago

Interventions

Paired Vagus Nerve Stimulationdevice

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

Rehabilitationother

Rehabilitation movements to improve upper limb function after stroke