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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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Studying the cerebral activity of children with Prader-Willi Syndrom (PWS) when the study propose to them nasal activations.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OT exposed patients | Experimental | children OT exposed have olfactory test and fMRI |
|
| OT non exposed patients | Active Comparator | children non- OT exposed have olfactory test and fMRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olfactory stimulation | Other | the patients have a sniff-test |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| hyperactivation of the right amygdala in PWS children stimulated by a sweet food odor vs. a non-food odor compared to non-exposed children. | intensity of right amygdala in fMRI | day 1 |
| composite outcome witn an association between olfactory fMRI results and eating behavior in early OT-exposed and non-exposed children with PWS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie CORTADELLAS | Contact | 0534557635 | cortadellas.j@chu-toulouse.fr | |
| Nadege ALGANS | Contact | 0561777204 | algans.n@chu-toulouse.fr |
| Name | Affiliation | Role |
|---|---|---|
| Gwenaelle DIENE, MD | University Hospital of Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Toulouse | 31059 | France |
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| ID | Term |
|---|---|
| D011218 | Prader-Willi Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| functional MRI | Other | patients have a an f MRI |
|
scores of the eating beahaviour questionnaires |
| day 1 |
| olfactory skills in early OT-exposed and non-exposed children with PWS. | scores of the sniff test between OT-exposed and non-exposed children. | Day 1 |
| resting brain connectivity in early OT-exposed and non-exposed children with PWS. | brain connectivity in fMRI between OT-exposed and non-exposed children. | day 1 |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D000096803 | Imprinting Disorders |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |