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A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS
NCT06144645 · View on ClinicalTrials.gov ↗
Study Summary
The goal of the VNS4PWS clinical study is to test the efficacy, safety, and acceptability of transcutaneous vagus nerve stimulation (tVNS) treatment in people with PWS.
Conditions Studied
Interventions
- DEVICE tVNS, intermittent stimulation
- DEVICE tVNS, continuous stimulation
Study Locations (18)
New York
- Maimonides Medical Center — Brooklyn
- NYU Langone Health — Garden City
- Montefiore Medical Center and Albert Einstein College of Medicine — The Bronx
California
- Stanford University — Palo Alto
- Rady Children's Hospital San Diego — San Diego
Georgia
- Emory University — Atlanta
- Rare Disease Research — Atlanta
Ohio
- University Hospitals Cleveland Medical Center — Cleveland
- Nationwide Children's Hospital — Columbus
Colorado
- Children's Hospital Colorado — Aurora
Iowa
- University of Iowa — Iowa City
Maryland
- Johns Hopkins Hospital — Baltimore
Minnesota
- University of Minnesota — Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2024-01-08 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06144645
The ClinicalTrials.gov registry entry for NCT06144645 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Foundation for Prader-Willi Research, which has 28 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Prader-Willi Syndrome appearing as the primary indexed condition, and to 2 interventions — of which tVNS, intermittent stimulation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06144645 reports 18 study locations spanning 13 distinct geographic areas — top geographies include New York, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06144645 about?
NCT06144645 is a clinical study titled "A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS". The goal of the VNS4PWS clinical study is to test the efficacy, safety, and acceptability of transcutaneous vagus nerve stimulation (tVNS) treatment in people with PWS.
What is the current status of trial NCT06144645?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 102 participants. The study started on 2024-01-08. Estimated completion is 2027-12-01.
What conditions does trial NCT06144645 study?
This clinical trial studies the following conditions: Prader-Willi Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06144645?
The interventions under investigation include: tVNS, intermittent stimulation (DEVICE), tVNS, continuous stimulation (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06144645?
This trial is sponsored by Foundation for Prader-Willi Research, which has 28 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06144645 being conducted?
This trial has 18 study locations across California, Colorado, Georgia, Iowa, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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