Clinical trial NCT06720571: Effects of Transcutaneous Vagus Nerve Stimulation on Emotion Regulation and Executive Functioning in Prader-Willi Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prader-Willi Syndrome
Keywords: Prader-Willi Syndrome
Vagus nerve stimulation
aVNT
t-VNS
Cognition
Executive functions
Inhibition
Flexibility
Planning
Updating
Emotion regulation
Behavior
Hyperphagia
Quality of life
Depression
Multicenter randomized controlled trial
Caregivers
Lead sponsor: University of Bordeaux
Sponsor class: OTHER
Collaborators: name: John Bost Foundation
name: University Hospital, Bordeaux
name: Hendaye hospital
name: Groupe Hospitalier Pitie-Salpetriere
name: CHU Toulouse
name: Prader-Willi Syndrome Association
First posted: 2024-12-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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). 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 trial. Twenty-four adults with PWS and 24 caregivers will be randomly assigned to receive either active or sham stimulation under identical conditions (four hours per day, seven days per week over nine months). The primary outcome, focusing on emotional control, will be assessed every two weeks for both participants and caregivers. Secondary outcomes (executive functions, hyperphagia, depression, and quality of life) will be measured at four time points: pre-intervention, at three months, six months, and at nine months.

As this is the first multicenter randomized controlled trial investigating the effects of aVNT as a treatment in PWS patients, we anticipate witnessing improved emotional regulation and reduced eating disorders, along with enhancements in executive functions and quality of life in the active stimulation group. The findings from this project could support the development of broader therapeutic approaches for other conditions in which behavioral disorders and emotional processing deficits affect patients and their caregivers.


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.

Primary outcomes:
measure: Evaluation of emotional control and regulation
timeFrame: Every 2 weeks for 11 months (including 3 times before and post-stimulation)
Secondary outcomes:
measure: Evaluation of Behavioral manifestations of executive functioning
timeFrame: 4 times (at 0, 3, 6 and 9 months)
measure: Evaluation of Executive functions
timeFrame: 4 times (at 0, 3, 6 and 9 months)
measure: Evaluation of Hyperphagia
timeFrame: 4 times (at 0, 3, 6 and 9 months)
measure: Evaluation of Depression
timeFrame: 4 times (at 0, 3, 6 and 9 months)
measure: Evaluation of Quality of life
timeFrame: 4 times (at 0, 3, 6 and 9 months)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Reference Center of Prader-Willi Syndrome (PRADORT)
city: Hendaye
country: France
facility: Reference Center of Prader-Willi Syndrome (CRMR PRADORT)
city: Paris
country: France
facility: Reference Center of Prader-Willi Syndrome (PRADORT)
city: Toulouse
country: France
facility: Reference Center of Prader-Willi Syndrome (PRADORT)
Study officials:
affiliation: University of Bordeaux
name: Virginie Postal, PhD
role: PRINCIPAL_INVESTIGATOR
References: