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

NCT ID NCT06144645

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for PRADER-WILLI SYNDROME are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

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