Brain Olfactory Pathways in Prader-Willi Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: olfactory stimulation, functional MRI.
- Who it may be relevant to
- Registry conditions: Prader-Willi Syndrome. Basic parameters: 5 years — 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Deciphering Brain Olfactory Pathways in Prader-Willi Syndrome
Overview
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.
Interventions
- Other olfactory stimulation
the patients have a sniff-test - Other functional MRI
patients have a an f MRI
Primary outcome measures
- 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. [Time frame: day 1]
Secondary outcome measures (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. [Time frame: day 1]
- composite outcome witn an association between olfactory fMRI results and eating behavior in early OT-exposed and non-exposed children with PWS. [Time frame: day 1]
- olfactory skills in early OT-exposed and non-exposed children with PWS. [Time frame: Day 1]
- resting brain connectivity in early OT-exposed and non-exposed children with PWS. [Time frame: day 1]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- University Hospital — Toulouse
Identifiers
NCT: NCT07006207 · RC31/23/0653