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

Studying vagus nerve stimulation for temper control in PWS patients.

Recruiting
10-40 years
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is testing a new device called **transcutaneous vagus nerve stimulation (tVNS)** to see if it can help reduce temper outbursts in people with **Prader-Willi Syndrome (PWS)**. PWS is a genetic condition that causes problems like overeating and behavioral issues. The study will last 9 months, with participants using the tVNS device for 4 hours daily. There will be two different doses tested, and the effect of stopping treatment will also be observed. After the initial study, participants can continue for another year if they wish.

  • Participants must be aged 10-40 with PWS and a history of temper outbursts.
  • They should be living with family or supportive staff, and have access to internet.
  • People with serious mental illness, heart issues, or certain allergies cannot join.

This study aims to find out if the tVNS device is safe and effective for people with PWS. Participants will need to be committed to the study schedule and requirements, and they can continue with their usual medications and therapy during the study.

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Study details
    Prader-Willi Syndrome

NCT06144645

Foundation for Prader-Willi Research

10 May 2025

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