Status:

RECRUITING

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

Lead Sponsor:

University of Bordeaux

Collaborating Sponsors:

John Bost Foundation

University Hospital, Bordeaux

Conditions:

Prader-Willi Syndrome

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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). Curren...

Eligibility 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.

Key Trial Info

Start Date :

November 22 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 30 2026

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT06720571

Start Date

November 22 2023

End Date

March 30 2026

Last Update

December 6 2024

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Reference Center of Prader-Willi Syndrome (PRADORT)

Bordeaux, France, 33600

2

Reference Center of Prader-Willi Syndrome (CRMR PRADORT)

Hendaye, France, 64700

3

Reference Center of Prader-Willi Syndrome (PRADORT)

Paris, France, 75013

4

Reference Center of Prader-Willi Syndrome (PRADORT)

Toulouse, France, 31000