Condition: Prader-Willi Syndrome · Sponsor: University of Bordeaux
The STIM-PRADER study aims to assess the effectiveness of auricular vagal neuromodulation therapy (aVNT) on emotional, behavioral, and cognitive domains impaired in Prader-Willi Syndrome (PWS). Currently, no treatment exists that addresses the multiple alterations associated with this rare neurodevelopmental disorder that significantly impact patients and their families. We will investigate the effects of daily, four-hour aVNT stimulation over a nine-month period on (a) emotion regulation, including assessing the persistence of effects following stimulation; (b) executive functions, including inhibition, flexibility, planning, and updating information in memory; (c) hyperphagia; (d) depression; (e) quality of life; (e) and the threshold at which effects on these dimensions can be observed. We will conduct a longitudinal multicenter parallel randomized controlled single-blind exploratory trial. Twenty-four adults with PWS and 24 caregivers will be randomly assigned to receive either active or sham stimulation under identical conditions (four hours per day, seven days per week over nine months). The primary outcome, focusing on emotional control, will be assessed every two weeks for both participants and caregivers. Secondary outcomes (executive functions, hyperphagia, depression, and quality of life) will be measured at four time points: pre-intervention, at three months, six months, and at nine months. As this is the first multicenter randomized controlled trial investigati…
This description comes directly from the study's public registry record.
Virginie Postal, PhD · +33 (0)57 57 19 74 · virginie.postal@u-bordeaux.fr
Camille Nahon, PhD student, neuropsychologist · +33 05 57 57 19 64 · camille.nahon@u-bordeaux.fr
Always discuss trial participation with your own doctor first.
| Reference Center of Prader-Willi Syndrome (PRADORT) | Bordeaux, France | Not Yet Recruiting |
| Reference Center of Prader-Willi Syndrome (CRMR PRADORT) | Hendaye, France | Recruiting |
| Reference Center of Prader-Willi Syndrome (PRADORT) | Paris, France | Recruiting |
| Reference Center of Prader-Willi Syndrome (PRADORT) | Toulouse, France | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06720571