Brain Olfactory Pathways in Prader-Willi Syndrome (PRADOL)

Toulouse University Hospital

Status: Not yet enrolling

Conditions: Prader-Willi Syndrome

Treatments: Other: olfactory stimulation; Other: functional MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT07006207

RC31/23/0653

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 5 to 7 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

OT exposed patients

Experimental group

Description:

children OT exposed have olfactory test and fMRI

Treatment:

Other: functional MRI

Other: olfactory stimulation

OT non exposed patients

Active Comparator group

Description:

children non- OT exposed have olfactory test and fMRI

Treatment:

Other: functional MRI

Other: olfactory stimulation