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NCT06720571: STIM-PRADER
Effects of Transcutaneous Vagus Nerve Stimulation on Emotion Regulation and Executive Functioning in Prader-Willi Syndrome
NA trial testing Auricular vagal neuromodulation therapy (aVNT) in Prader-Willi Syndrome in 24 participants. Currently enrolling.
30 March 2026
Quick facts
| Lead sponsor | University of Bordeaux |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 22 November 2023 |
| Primary completion | 30 March 2026 |
| Estimated completion | 30 March 2026 |
| Sites | 4 locations across France |
Drugs / interventions tested
- Auricular vagal neuromodulation therapy (aVNT)
- Sham Auricular vagal neuromodulation therapy (aVNT)
Conditions studied
- Prader-Willi Syndrome — all drugs for Prader-Willi Syndrome →
Sponsor
University of Bordeaux
Who can join
18 and older, any sex, with Prader-Willi Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06720571
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Prader-Willi Syndrome
Currently open trials in the same condition.
- NCT06877715 — Autistic Symptomatology and Sensory Profile in Children With Prader-Willi Syndrome · recruiting
- NCT06772597 — A Study of Setmelanotide in Patients With Prader-Willi Syndrome · Phase 2 · active not recruiting
- NCT06573723 — Institutional Registry of Rare Diseases · recruiting
- NCT06239116 — A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment · Phase 1, PHASE2 · recruiting
- NCT06144645 — A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS · Phase 3 · active not recruiting
Other University of Bordeaux trials
Trials by the same sponsor.
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- NCT05805527 — Evaluating the Validity and Acceptability of a Fully-automated Interview to Diagnose Insomnia Disorder: a Pilot Study · completed
- NCT06266039 — Introduction of Long Acting Buprenorphine in France · unknown
- NCT06720792 — Cocreation and Evaluation of an Escape Game on Students' Mental Health · NA · recruiting
- NCT05052177 — Percutaneous Edge To Edge Repair for the Treatment of Severe Tricuspid Valve Regurgitation in High-surgical Risk Patient · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06720571 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Bordeaux
- Last refreshed: 6 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06720571.
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