Using vagus nerve stimulation to improve emotion and thinking in Prader-Willi Syndrome
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
This study is testing whether a new treatment using vagus nerve stimulation can help improve emotions and thinking skills in adults with Prader-Willi Syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Bordeaux Academic / other |
| Locations | 4 sites (Bordeaux and 3 other locations) |
| Trial ID | NCT06720571 on ClinicalTrials.gov |
What this trial studies
The STIM-PRADER study evaluates the effectiveness of auricular vagal neuromodulation therapy (aVNT) in enhancing emotional regulation, executive functioning, and overall quality of life in adults with Prader-Willi Syndrome (PWS). This interventional trial will involve 24 adults with PWS and their caregivers, who will be randomly assigned to receive either active or sham stimulation over a nine-month period. The study aims to assess various cognitive and emotional outcomes, including hyperphagia and depression, to determine the therapy's impact on this rare neurodevelopmental disorder. The trial is designed as a longitudinal multicenter parallel randomized controlled single-blind exploratory study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with Prader-Willi Syndrome and meeting specific cognitive and behavioral criteria.
Not a fit: Patients with untreated psychiatric disorders, severe sensory impairments, or certain medical devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve emotional and cognitive functioning in patients with Prader-Willi Syndrome.
How similar studies have performed: While the approach of using vagus nerve stimulation is gaining interest, this specific application in Prader-Willi Syndrome is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Participant with PWS: Untreated and unstabilized psychiatric and/or behavioral disorders (psychological decompensation within the last year); Severe visual or hearing impairment; Untreated sleep apnea syndrome; Epileptic seizures; Previous significative ECG abnormality; Adults with pacemakers or defibrillators; Metal or electronic devices implanted in the head; Participation in other research involving an exclusion period still in progress at inclusion; Score ≥ 30 indicating severe depression (BDI-II self-report questionnaire); Pregnant or breast-feeding women.
Where this trial is running
Bordeaux and 3 other locations
- 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)
Study contacts
- Principal investigator: Virginie Postal, PhD — University of Bordeaux
- Study coordinator: Virginie Postal, PhD
- Email: virginie.postal@u-bordeaux.fr
- Phone: +33 (0)57 57 19 74
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.