A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS
Public ClinicalTrials.gov record NCT06144645. 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 Phase 3, Randomized, Double-Blind, Dose-Ranging Evaluation of Transcutaneous Vagus Nerve Stimulation (tVNS) to Reduce Temper Outbursts in People With Prader-Willi Syndrome (PWS)
Study identification
- NCT ID
- NCT06144645
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Foundation for Prader-Willi Research
- Other
- Enrollment
- 102 participants
Conditions and interventions
Conditions
Interventions
- tVNS, continuous stimulation Device
- tVNS, intermittent stimulation Device
Device
Eligibility (public fields only)
- Age range
- 10 Years to 40 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
- Jan 7, 2024
- Primary completion
- Mar 31, 2027
- Completion
- Mar 31, 2027
- Last update posted
- Apr 5, 2026
2024 – 2027
United States locations
- U.S. sites
- 18
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | — |
| Rady Children's Hospital San Diego | San Diego | California | 92123 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Rare Disease Research | Atlanta | Georgia | 30329 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 | — |
| University of Minnesota | Minneapolis | Minnesota | 55454 | — |
| Children's Mercy Kansas City | Kansas City | Missouri | 64108 | — |
| Maimonides Medical Center | Brooklyn | New York | 11219 | — |
| NYU Langone Health | Garden City | New York | 11530 | — |
| Montefiore Medical Center and Albert Einstein College of Medicine | The Bronx | New York | 10461 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | — |
| Christus Children'S | San Antonio | Texas | 78207 | — |
| University of Utah | Salt Lake City | Utah | 84108 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06144645, 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 Apr 5, 2026 · Synced May 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06144645 live on ClinicalTrials.gov.