Brain Olfactory Pathways in Prader-Willi Syndrome

NCT07006207 | Not Yet Recruiting

• 1 other identifier: RC31/23/0653
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prader-Willi Syndrome

Keywords

cerebral activity; Olfactory activation

Outcome Measures

Primary Outcomes (1)

• 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.

  intensity of right amygdala in fMRI

  day 1

Secondary Outcomes (4)

• 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

• composite outcome witn an association between olfactory fMRI results and eating behavior in early OT-exposed and non-exposed children with PWS.

  day 1

• olfactory skills in early OT-exposed and non-exposed children with PWS.

  Day 1

• resting brain connectivity in early OT-exposed and non-exposed children with PWS.

  day 1

Study Arms (2)

OT exposed patients

EXPERIMENTAL

children OT exposed have olfactory test and fMRI

Other: olfactory stimulation; Other: functional MRI

OT non exposed patients

ACTIVE COMPARATOR

children non- OT exposed have olfactory test and fMRI

Other: olfactory stimulation; Other: functional MRI

Interventions

olfactory stimulation OTHER

the patients have a sniff-test

OT exposed patients; OT non exposed patients

functional MRI OTHER

patients have a an f MRI

OT exposed patients; OT non exposed patients

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Presence of a contraindication to MRI
• Allergy to any of the fragrances used in the olfactory test
• Reported anosmia
• Administrative problems.

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

University Hospital

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Prader-Willi Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Gwenaelle DIENE, MD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie CORTADELLAS

CONTACT

0534557635; cortadellas.j@chu-toulouse.fr

Nadege ALGANS

CONTACT

0561777204; algans.n@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 5, 2025
• Study Start: June 23, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)