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

RecruitingNAAges 18 Years - anyAllUniversity of Bordeaux
NCT06720571 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Auricular vagal neuromodulation therapy (aVNT)
  • Sham Auricular vagal neuromodulation therapy (aVNT)
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Where

4 sites
Reference Center of Prader-Willi Syndrome (PRADORT)
Bordeaux, France
Reference Center of Prader-Willi Syndrome (CRMR PRADORT)
Hendaye, France
Reference Center of Prader-Willi Syndrome (PRADORT)
Paris, France
Reference Center of Prader-Willi Syndrome (PRADORT)
Toulouse, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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