Auricular Vagal Neuromodulation Therapy (aVNT) for Enhancing Emotion Regulation, Executive Functions, Hyperphagia, and Quality of Life in Prader-Willi Syndrome: A Multicenter Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the effects of auricular vagal neuromodulation therapy (aVNT) on adults with Prader-Willi Syndrome (PWS), a rare neurodevelopmental disorder. The study aims to assess how daily aVNT stimulation impacts emotional control, executive functions such as planning and flexibility, hyperphagia, depression, and quality of life. This is the first multicenter randomized controlled trial exploring aVNT as a treatment for PWS, which currently has no therapies addressing its many behavioral and cognitive challenges. Participants will be randomly assigned to receive either active or sham aVNT stimulation using a small portable device with electrodes placed on the left ear. The stimulation sessions last four hours per day, seven days a week, over nine months. The device delivers painless electrical microcurrents to stimulate the auricular branch of the vagus nerve. Active stimulation is adjusted by participants for comfort and occurs during relaxing activities. The sham group uses the same device but with stimulation applied to an area without vagus nerve fibers. During the study, emotional control will be measured every two weeks for eleven months, including before and after the stimulation period. Other outcomes like executive functioning, hyperphagia, depression, and quality of life will be assessed four times: before treatment, and at three, six, and nine months. Participants and their caregivers will be involved in evaluations. The study includes safety monitoring and aims to understand the persistence of effects after stimulation ends.

Effects of Transcutaneous Vagus Nerve Stimulation on Emotion Regulation and Executive Functioning in Prader-Willi Syndrome