Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB)
Public ClinicalTrials.gov record NCT03131960. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Pivotal Randomized Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function After Stroke (VNS-REHAB)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03131960
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 108 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 1, 2017 (Actual)
- Primary completion
- Apr 30, 2020 (Actual)
- Completion
- Jun 30, 2022 (Actual)
- Last update posted
- Jul 20, 2022
2017 – 2022
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Perseverance Research Center | Scottsdale | Arizona | 85254 | — |
| Rancho Research Institute | Downey | California | 90242 | — |
| Providence St. John's Medical Center | Santa Monica | California | 90404 | — |
| Mayo Jacksonville / Brooks Rehabilitation | Jacksonville | Florida | 32224 | — |
| Emory University Medical School | Atlanta | Georgia | 30329 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02129 | — |
| Spectrum Health | Grand Rapids | Michigan | 49503 | — |
| New York Presbyterian Hospital / Weill Cornell Medicine | New York | New York | 10065 | — |
| Burke Medical Research Institute | White Plains | New York | 10605 | — |
| Ohio State University - Neuroscience Research Institute | Columbus | Ohio | 43210 | — |
| Thomas Jefferson | Philadelphia | Pennsylvania | 19107 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37240 | — |
| UT Southwestern | Dallas | Texas | 75390 | — |
| TIRR Memorial Hermann (UT Health Science Center at Houston) | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03131960, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 20, 2022 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03131960 live on ClinicalTrials.gov.