Brain Olfactory Pathways in Prader-Willi Syndrome

Not Applicable

Not yet recruiting

• Conditions: Prader-Willi Syndrome

• Registration Number: NCT07006207
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Studying the cerebral activity of children with Prader-Willi Syndrom (PWS) when the study propose to them nasal activations.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05
• Study Start: 2025-06-23
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
hyperactivation of the right amygdala in young children with PWS not early OT-exposed and aged between 5 and 7 years in response to a sweet food odor compared to a neutral non-food odor.	day 1	intensity of right amygdala in fMRI

Secondary Outcome Measures

Name	Time	Method
hyperactivation of the right amygdala in PWS children stimulated by a sweet food odor vs. a non-food odor compared to non-exposed children.	day 1	intensity of right amygdala in fMRI
composite outcome witn an association between olfactory fMRI results and eating behavior in early OT-exposed and non-exposed children with PWS.	day 1	scores of the eating beahaviour questionnaires
olfactory skills in early OT-exposed and non-exposed children with PWS.	Day 1	scores of the sniff test between OT-exposed and non-exposed children.
resting brain connectivity in early OT-exposed and non-exposed children with PWS.	day 1	brain connectivity in fMRI between OT-exposed and non-exposed children.

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Toulouse, France