NCT06144645

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

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Foundation for Prader-Willi Research · Academic / Other
• Sex: All
• Age: 10 Years – 40 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
DEVICE	tVNS, intermittent stimulation	transcutaneous vagus nerve stimulation, intermittent stimulation
DEVICE	tVNS, continuous stimulation	transcutaneous vagus nerve stimulation, continuous stimulation

Timeline

• Start date: 2024-01-08
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2023-11-22
• Last updated: 2026-04-06

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated device study