Using vagus nerve stimulation to improve emotion and thinking in Prader-Willi Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Reference Center of Prader-Willi Syndrome (PRADORT)
  Bordeaux, France Not yet 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Group therapy to help teens with Prader-Willi regulate emotions

  Teens with Prader-Willi Syndrome and their families will try a group therapy program to help calm emotions and reduce irritability and anxiety.

  Recruiting Children's Mercy Hospital Kansas City · Kansas City, Missouri · NCT07607730

• CSTI-500 in Prader-Willi Syndrome: a dose-escalation study for safety and efficacy

  This study tests CSTI-500 in people aged 13–50 with Prader-Willi syndrome to see if it is safe and helps with symptoms, using increasing doses guided by blood levels.

  Recruiting Phase 2 ConSynance Therapeutics · Nashville, Tennessee · NCT07348601

• Using Tirzepatide to treat obesity in young adults with Prader-Willi Syndrome and hypothalamic obesity

  This study is testing if a weight loss medication called Tirzepatide can help young adults with Prader-Willi Syndrome and hypothalamic obesity lose weight and improve their health.

  Recruiting at 3 sites Phase 4 Seattle Children's Hospital · Saint Paul, Minnesota and 2 other locations · NCT06901245

• Examining autistic traits and sensory profiles in children with Prader-Willi Syndrome

  This study looks at how autistic traits and sensory experiences show up in children with Prader-Willi Syndrome to better understand their needs and see if early oxytocin treatment makes a difference.

  Recruiting University Hospital, Toulouse · Toulouse · NCT06877715

• Inclusive physical activity program for adults with intellectual disabilities

  This study is testing a new fitness program for adults with intellectual disabilities to see if it helps them be more active and feel better over 16 weeks.

  Recruiting University of North Carolina, Chapel Hill · Fayetteville, Arkansas and 1 other locations · NCT06740162

• Registry for Rare Diseases

  This study is creating a detailed registry to collect information on rare diseases like amyloidosis and sarcoidosis to help improve how they are diagnosed and treated.

  Recruiting Hospital Italiano de Buenos Aires · Buenos Aires, Buenos Aires · NCT06573723

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.