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

Study on vagus nerve stimulation for temper outbursts in PWS patients.

Recruiting
10-40 years
All
Phase 3

This study is about testing a new way to help people with Prader-Willi Syndrome (PWS) manage temper outbursts. PWS is a genetic condition that can affect behavior. The study uses a device called transcutaneous vagus nerve stimulation (tVNS), which sends small signals to a nerve in your neck. Participants will wear this device for 4 hours every day for 9 months. The study wants to know if this treatment is safe, if people like it, and if it really helps with temper outbursts.

Key Points:

  • Duration: The study lasts for 9 months, and you can continue for another year if you want.
  • Visits: Participants will need to share data like daily temper outbursts and device usage with the study team.
  • Eligibility: You need to be between 10-40 years old, have PWS, and have had at least two temper outbursts a week in the last six months.

Participants should speak English fluently and live with family or caregivers who will help with the study. Some health conditions or recent changes in your living situation could prevent participation. If you are interested, let a doctor know to see if you qualify!

Study details
    Prader-Willi Syndrome

NCT06144645

Foundation for Prader-Willi Research

18 January 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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