ClinicalTrials.gov record NCT06720571

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old and older
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized, single-blind, multicenter trial tests daily auricular vagal neuromodulation (aVNT) versus a sham device in adults with Prader-Willi Syndrome and their caregivers. Participants use the device four hours per day, seven days a week, for nine months; emotional control is measured every two weeks and other outcomes at baseline, 3, 6, and 9 months. The study compares active stimulation to a control condition under the same schedule.

What it is studying. The study is testing whether daily, home‑used auricular vagal neuromodulation (aVNT) has measurable effects compared with a sham device on emotional control and regulation, on several aspects of executive functioning (inhibition, flexibility, planning, updating), on hyperphagia, on depressive symptoms, and on overall quality of life. It also assesses the timing and persistence of any effects during and after the stimulation period.

What the researchers hope to learn. To determine whether auricular vagal neuromodulation produces measurable changes in emotion regulation, executive functions, hyperphagia, depression, and quality of life in adults with Prader‑Willi Syndrome. To describe when effects appear, how long they last, and to provide data that could inform future therapeutic approaches for related behavioral and emotional disorders.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

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

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants (and enrolled caregivers) will be randomly assigned to active or sham ear stimulation and asked to use a small device on the left ear about four hours per day (sessions may be split), seven days a week for nine months, adjusting intensity for comfort and avoiding stimulation during sleep, meals, or major physical activity. Emotional-control measures will be collected every two weeks for about 11 months; broader assessments—computerized executive‑function tasks and questionnaires for hyperphagia, depression, and quality of life—will occur at baseline and at 3, 6, and 9 months.

How the study is structured. A multicenter, randomized, parallel-group, single-blind interventional trial. Twenty-four adults with Prader-Willi Syndrome and 24 caregivers are randomly assigned to active aVNT or sham stimulation. The device is used about four hours per day (sessions may be split) for nine months. Emotional control (primary outcome) is assessed every two weeks; secondary measures are taken at baseline, 3, 6, and 9 months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Prader-Willi syndrome

Clinical trials19 trials listed for Prader-Willi syndromeEvery trial the registry lists for Prader-Willi syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Prader-Willi syndrome researchLatest monthly update: September 2026. Includes: Hunger symptoms. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Nov 22, 2023
Primary completion
Mar 30, 2026 (estimated)
Study completion
Mar 30, 2026 (estimated)
Target enrollment
24 participants (estimated)
Last updated on registry
Dec 6, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Bordeaux
Principal investigator
Virginie Postal, Researcher and Professor
University of Bordeaux
Collaborators
  • John Bost Foundation
  • University Hospital, Bordeaux
  • Hendaye hospital
  • Groupe Hospitalier Pitie-Salpetriere
  • University Hospital, Toulouse
  • Prader-Willi Syndrome Association

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (4)

Terms used on this page · explanations by MedicalUpdates.ai

randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
sham
A procedure designed to resemble the real procedure, for example the same visit and equipment, without its active part. It is the procedure equivalent of a placebo.
primary outcome
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
ECG
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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