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NCT03131960 · ClinicalTrials.gov registry record · NA
Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB)
A NA study, sponsored by MicroTransponder.
- Completed
- Registry status
- NA
- Development phase
- 108
- Enrollment target
NCT03131960: Completed NA study, sponsored by MicroTransponder.
NCT03131960 is a NA study that has completed, run by MicroTransponder. The registered enrollment target is 108 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03131960, a NA study, has completed, sponsored by MicroTransponder.
- COMPLETED
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
Study 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.
Primary Outcome
The Fugl-Meyer Assessment, Upper Limb (FMA-UE) was analyzed for difference in average change at 1-day after 6-weeks of therapy compared to baseline (Difference in average change in FM-A from baseline \[V4\] to one day after therapy \[V5\]). The upper extremity portion of the Fugl-Meyer Assessment (FMA-UE) was collected at each visit. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment).
Interventions
- OTHER Rehabilitation
- DEVICE Paired Vagus Nerve Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2022-06-30 |
| Phase | NA |
What the finished NCT03131960 record still lists
NCT03131960 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Rehabilitation is the first listed.
NCT03131960 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03131960 about?
NCT03131960 is a clinical study titled "Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB)". 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...
What is the current status of trial NCT03131960?
This trial is currently completed. It is a NA study. The enrollment target is 108 participants. The study started on 2017-07-01. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT03131960?
The interventions under investigation include: Rehabilitation (OTHER), Paired Vagus Nerve Stimulation (DEVICE).
Who is sponsoring clinical trial NCT03131960?
This trial is sponsored by MicroTransponder, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03131960's enrollment target sits among peer trials
108 825th of 2000 higher than 1,171 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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