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

NCT ID NCT06144645

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 102 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Genetically proven diagnosis of PWS. 2. Age 10-40 years. 3. History in the last six months of an average of at least two temper outbursts per week. 4. Able to comply with requirements of study and provide consent or assent; If consent is to be provided by the participant's guardian, same applies to the guardian. 5. Concomitant use of psychiatric medication is allowed; participant must be on a stable dose 90 days prior to screening with no plans for dose modification during the course of the study. 6. Concomitant use of psychotherapy/counseling is allowed. Therapies for mental health or behavior challenges, including applied behavior analysis (ABA) are also allowed; however, participant must be on a stable regimen 90 days prior to screening with no plans for modification during the course of the study. 7. Living with family or in another setting with family members or staff willing to support the participant and the required data collection. 8. Agree to share tVNS patient application compliance and daily temper outburst data with the sponsor. 9. Access to cellular data or Wi-Fi. 10. Participant and caregiver speak American English as first language or are fluent in American English. Exclusion Criteria: 1. Positive pregnancy test at screening, baseline, or at any point in the study. 2. Evidence of active or recent unstable serious mental illness, including, psychosis, mania, severe depression, or suicidality. 3. Moved to present residential placement in last three months or less. 4. Likely move in residential placement during the course of the study. 5. Cardiac abnormalities including medically documented history of cardiac disease or cardiac arrhythmia, documented resting heart rate ≤ 50 beats per minute (BPM); or history of 2° type 2 or 3° heart block on electrocardiogram (ECG). 6. Evidence of clinically significant abnormalities of blood, liver, or kidney function from clinical safety laboratory assessments as determined by the Site Investigator. 7. History of blood clot, pulmonary embolism, or deep vein thrombosis. 8. Prior diagnosis of epilepsy or currently active seizures. 9. Current enrollment in the active phase of different clinical trial or interventional study. 10. Current use of hearing aids or implantable medical devices including implanted vagus nerve stimulation (iVNS) device, implanted cardiac pacemaker, implanted cardiac defibrillator, cochlear implants, cerebral shunt or cardiac implantable electrical devices. 11. Presence of dermal abnormalities at the stimulation site that would interfere with the ability of the tVNS device to function properly. 12. Presence of an allergy to titanium, titanium-iridium, thermoplastic elastomers, perfluoroethylene propylene, or polyurethane elastomers, or components of / preservatives present in the device electrode cream (Ceteareth-20, Propylene Glycol, Bentonite, Polysorbate 20, Phenoxyethanol, Ethylhexylglycerin). 13. Severe, untreated sleep apnea, as self-reported by subject or caregiver or suspected by Site Investigator. 14. Subject is, in the opinion of the Investigator, not suitable to participate in the study.

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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

More trials for these conditions

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