A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS

Running, not enrolling · Phase 3

Conditions studied: Prader-Willi Syndrome

In brief

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.

Key facts

Study ID

NCT06144645

Run by

Foundation for Prader-Willi Research

People needed

102

Starts

2024-01-08

Expected to finish

2027-04-01

Last updated by the study team

2026-04-06

Who can join

Age: 10 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Genetically proven diagnosis of PWS.
• Age 10-40 years.
• History in the last six months of an average of at least two temper outbursts per week.
• 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.
• 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.
• 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.
• Living with family or in another setting with family members or staff willing to support the participant and the required data collection.
• Agree to share tVNS patient application compliance and daily temper outburst data with the sponsor.
• Access to cellular data or Wi-Fi.
• Participant and caregiver speak American English as first language or are fluent in American English.

You may not qualify if…

• Positive pregnancy test at screening, baseline, or at any point in the study.
• Evidence of active or recent unstable serious mental illness, including, psychosis, mania, severe depression, or suicidality.
• Moved to present residential placement in last three months or less.
• Likely move in residential placement during the course of the study.
• 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).
• Evidence of clinically significant abnormalities of blood, liver, or kidney function from clinical safety laboratory assessments as determined by the Site Investigator.
• History of blood clot, pulmonary embolism, or deep vein thrombosis.
• Prior diagnosis of epilepsy or currently active seizures.
• Current enrollment in the active phase of different clinical trial or interventional study.
• 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.
• Presence of dermal abnormalities at the stimulation site that would interfere with the ability of the tVNS device to function properly.
• 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).
• Severe, untreated sleep apnea, as self-reported by subject or caregiver or suspected by Site Investigator.
• Subject is, in the opinion of the Investigator, not suitable to participate in the study.

Where it is running

• University of Utah — Salt Lake City, Utah, United States
• University of Virginia — Charlottesville, Virginia, United States
• Stanford University — Palo Alto, California, United States
• Rady Children's Hospital San Diego — San Diego, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Emory University — Atlanta, Georgia, United States
• Rare Disease Research — Atlanta, Georgia, United States
• University of Iowa — Iowa City, Iowa, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Children's Mercy Kansas City — Kansas City, Missouri, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• NYU Langone Health — Garden City, New York, United States
• Montefiore Medical Center and Albert Einstein College of Medicine — The Bronx, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Christus Children'S — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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