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)
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.
• 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.