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Non-invasive vagus nerve stimulation for temper outbursts in Prader-Willi syndrome

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)

Phase 3 Interventional Foundation for Prader-Willi Research · NCT06144645

This study is testing whether a non-invasive device that stimulates the vagus nerve can help reduce temper outbursts in people with Prader-Willi syndrome aged 10 to 40.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment102 (estimated)
Ages10 Years to 40 Years
SexAll
SponsorFoundation for Prader-Willi Research Academic / other
Locations14 sites (Palo Alto, California and 13 other locations)
Trial IDNCT06144645 on ClinicalTrials.gov

What this trial studies

This clinical evaluation aims to assess the efficacy, safety, and acceptability of transcutaneous vagus nerve stimulation (tVNS) in individuals with Prader-Willi Syndrome (PWS). Participants aged 10-40 will wear a tVNS device for four hours daily over nine months, comparing two different stimulation doses. The study will also investigate the effects of discontinuing treatment during the final three months. Following the initial year, participants may enter a one-year open-label extension to continue active treatment.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 10-40 with a genetically confirmed diagnosis of Prader-Willi Syndrome who experience frequent temper outbursts.

Not a fit: Patients who do not have a diagnosis of Prader-Willi Syndrome or those who do not experience temper outbursts may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce temper outbursts in individuals with Prader-Willi Syndrome, improving their quality of life.

How similar studies have performed: While the specific application of tVNS for temper outbursts in PWS is novel, similar approaches using vagus nerve stimulation have shown promise in other conditions.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Palo Alto, California and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prader-Willi SyndromePrader-Willi syndromePWSPrader
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.