Could a gentle nerve zap curb explosive outbursts in Prader-Willi syndrome?

NCT ID NCT06144645

Ongoing Symptom relief Sponsor: Foundation for Prader-Willi Research Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 study tests a device that gently stimulates the vagus nerve through the skin (tVNS) to see if it can safely reduce temper outbursts in people with Prader-Willi syndrome. About 102 participants aged 10 to 40 will use either continuous or intermittent stimulation. The study measures safety, how well people tolerate the device, and changes in irritability and outburst frequency.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: transcutaneous vagus nerve stimulation (tVNS) device
What this could lead to: If it works, this could provide a non-drug option to reduce temper outbursts in people with Prader-Willi syndrome, improving daily life for them and their families.
What could go wrong: This is a phase 3 trial, but results are not yet available. The device may not reduce outbursts significantly, and some people may find the stimulation uncomfortable or withdraw from the study.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Prader-Willi syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PRADER-WILLI SYNDROME

Contacts and locations

Locations

Children's Hospital Colorado

Aurora, Colorado, 80045, United States
Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States
Christus Children'S

San Antonio, Texas, 78207, United States
Emory University

Atlanta, Georgia, 30322, United States
Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States
Maimonides Medical Center

Brooklyn, New York, 11219, United States
Montefiore Medical Center and Albert Einstein College of Medicine

The Bronx, New York, 10461, United States
NYU Langone Health

Garden City, New York, 11530, United States
Nationwide Children's Hospital

Columbus, Ohio, 43205, United States
Rady Children's Hospital San Diego

San Diego, California, 92123, United States
Rare Disease Research

Atlanta, Georgia, 30329, United States
Stanford University

Palo Alto, California, 94304, United States
University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States
University of Iowa

Iowa City, Iowa, 52242, United States
University of Minnesota

Minneapolis, Minnesota, 55454, United States
University of Utah

Salt Lake City, Utah, 84108, United States
University of Virginia

Charlottesville, Virginia, 22908, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

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