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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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