Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that has completed, run by MicroTransponder. The registered enrollment target is 108 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03131960
The ClinicalTrials.gov registry entry for NCT03131960 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MicroTransponder, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rehabilitation is the first listed.
NCT03131960 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.