ClinicalTrials.gov record NCT07006207
Brain Olfactory Pathways in Prader-Willi Syndrome
Deciphering Brain Olfactory Pathways in Prader-Willi Syndrome
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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 interventional study looks at how the brains of children with Prader-Willi syndrome respond to smells and how well they can smell. It compares children who were exposed early to OT with children who were not. Participants undergo smell testing (a sniff test) and a functional MRI.
What it is studying. The study uses functional MRI (fMRI) and olfactory (sniff) tests to describe brain activation linked to smell and to measure smell skills in children with Prader-Willi syndrome. It compares children who were early OT-exposed with children who were not, including responses to a sweet food odor versus a neutral odor, resting brain connectivity, and links between brain responses and eating-behavior scores.
What the researchers hope to learn. To describe olfactory brain activation patterns and smell ability in young children with PWS, to compare these measures between early OT-exposed and non-exposed children, to examine resting brain connectivity, and to explore associations between olfactory fMRI results and eating-behavior scores.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Studying the cerebral activity of children with Prader-Willi Syndrom (PWS) when the study propose to them nasal activations.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- olfactory stimulation
- functional MRI
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- child with a genetically confirmed diagnosis of PWS and for whom the genetic subtype (deletion or non deletion) has been identified
- Child aged between 5 and 7 years
- Child with a planned hospitalization at the Toulouse reference center for PWS
Exclusion criteria
- Presence of a contraindication to MRI
- Allergy to any of the fragrances used in the olfactory test
- Presence of an ENT infection such as rhinitis or sinusitis on the day of inclusion
- Reported anosmia
- Administrative problems.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
The present study propose to implement fMRI and olfactory tests to describe olfactory brain activation and olfactory skills in early OT-exposed and non-exposed children with PWS. This study is part of a wider project in collaboration with the team of S. Steculorum at the Max Planck Institute in Germany who assess the architectural and molecular characterization of the olfactory system development in a mice model of PWS and the role of early OT treatment. Moreover, the study will take advantage of the MRI to document the long-term brain connectivity of early OT-exposed and non-exposed children.
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.
During the planned hospital visit children will complete an olfactory sniff-test (olfactory stimulation) and have a functional MRI scan to record brain activity, including resting connectivity. Caregivers will complete questionnaires about eating behavior and olfactory skills will be scored. The record lists these assessments as occurring on the same study day (day 1). Children with MRI contraindications, fragrance allergies, an ENT infection on the day, or reported anosmia may be excluded.
How the study is structured. Interventional, non-randomized, parallel two-group study with no masking. Children are placed into two groups based on prior early OT exposure (OT-exposed vs non-exposed). All participants receive olfactory stimulation (sniff test) and a functional MRI, including task-based (odor) scans and resting-state connectivity scans.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- 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
Important dates
- Study start
- Jun 23, 2025 (estimated)
- Primary completion
- December 2025 (estimated)
- Study completion
- December 2025 (estimated)
- Target enrollment
- 30 participants (estimated)
- Last updated on registry
- Jun 5, 2025
- 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 Hospital, Toulouse
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
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.
- Julie CORTADELLAS 📞 0534557635 ✉ cortadellas.j@chu-toulouse.fr
- Nadege ALGANS 📞 0561777204 ✉ algans.n@chu-toulouse.fr
Participating sites (1)
- University Hospital
Toulouse, 31059 · France
- Gwenaelle DIENE, MD
Terms used on this page · explanations by MedicalUpdates.ai
- contraindication
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- 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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