Status:
RECRUITING
A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS
Lead Sponsor:
Foundation for Prader-Willi Research
Collaborating Sponsors:
RTI International
Conditions:
Prader-Willi Syndrome
Eligibility:
All Genders
10-40 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
The main questions the VNS4PWS study seeks to answer are: (1) is tVNS treatment safe in people with PWS, (2) is tVNS treatment acceptable to people with PWS, and (3) is tVNS an effective treatment to ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT06144645
Start Date
January 8 2024
End Date
December 1 2027
Last Update
November 25 2025
Active Locations (18)
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1
Stanford University
Palo Alto, California, United States, 94304
2
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
3
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
4
Emory University
Atlanta, Georgia, United States, 30322