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A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS — VNS4PWS  

Prader-Willi Syndrome Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial 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 reduce temper outbursts in people with PWS. Participants will wear the tVNS device daily for 4 hours over a period of 9 months. Two different doses of tVNS will be compared. During the final three months of the trial, the effect of stopping treatment will be studied. After the first year of the study, participants will have the opportunity to continue on to a 1-year open label extension period during which active tVNS treatment will be resumed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06144645
Study type Interventional
Source Foundation for Prader-Willi Research
Contact Lisa Matesvac, AuD
Phone (760)420-5878
Email VNS@fpwr.org
Status Recruiting
Phase Phase 3
Start date January 8, 2024
Completion date December 1, 2027
View Details
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