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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 investigating the effects of aVNT as a treatment in PWS patients, we anticipate witnessing improved emotional regulation and reduced eating disorders, along with enhancements in executive functions and quality of life in the active stimulation group. The findings from this project could support the development of broader therapeutic approaches for other conditions in which behavioral disorders and emotional processing deficits affect patients and their caregivers.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant with PWS: Age : ≥ 18 years old; Diagnosis of Prader-Willi syndrome with identified genotype; Intellectual Quotient ≥ 55 measured by WAIS-IV (abbreviated version); Pathological or threshold score on at least one of the BRIEF-A subscales; Adults volunteering and able to comply with study procedures; Signature of informed consent form; Beneficiary of a social security regime

• Caregivers: Caregivers involved in the participant's family, medical or institutional environment; Caregiver who has signed the informed consent form.

Locations
Other Locations
France
Reference Center of Prader-Willi Syndrome (PRADORT)
NOT_YET_RECRUITING
Bordeaux
Reference Center of Prader-Willi Syndrome (CRMR PRADORT)
RECRUITING
Hendaye
Reference Center of Prader-Willi Syndrome (PRADORT)
RECRUITING
Paris
Reference Center of Prader-Willi Syndrome (PRADORT)
RECRUITING
Toulouse
Contact Information
Primary
Virginie Postal, PhD
virginie.postal@u-bordeaux.fr
+33 (0)57 57 19 74
Backup
Camille Nahon, PhD student, neuropsychologist
camille.nahon@u-bordeaux.fr
+33 05 57 57 19 64
Time Frame
Start Date: 2023-11-22
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 24
Treatments
Experimental: Active stimulation
Sham_comparator: Sham stimulation
Related Therapeutic Areas
Sponsors
Leads: University of Bordeaux
Collaborators: University Hospital, Toulouse, John Bost Foundation, University Hospital, Bordeaux, Groupe Hospitalier Pitie-Salpetriere, Hendaye hospital, Prader-Willi Syndrome Association

This content was sourced from clinicaltrials.gov