University Hospital
Toulouse, 31059, France
Location contact
Gwenaelle DIENE, MD
CONTACT
Not Yet Recruiting
NCT Number: NCT07006207
Brain Olfactory Pathways in Prader-Willi Syndrome
Studying the cerebral activity of children with Prader-Willi Syndrom (PWS) when the study propose to them nasal activations.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Prader-Willi Syndrome
Abnormalities, Multiple
Chromosome Disorders
Congenital Abnormalities
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Genetic Diseases, Inborn
Imprinting Disorders
Intellectual Disability
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Nutrition Disorders
Nutritional and Metabolic Diseases
Obesity
Overnutrition
Overweight
Age range
5 year–7 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Olfactory stimulation
Otherthe patients have a sniff-test
Functional MRI
Otherpatients have a an f MRI
Primary outcomes
-
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
intensity of right amygdala in fMRI
Secondary outcomes
-
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
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.
Time frame: day 1
scores of the eating beahaviour questionnaires
-
olfactory skills in early OT-exposed and non-exposed children with PWS.
Time frame: 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.
Time frame: day 1
brain connectivity in fMRI between OT-exposed and non-exposed children.
Study contacts
Contact information is provided by the study sponsor or research team.
Julie CORTADELLAS
CONTACT
Nadege ALGANS
CONTACT
Sponsors and collaborators
Lead sponsor
University Hospital, Toulouse
Other
Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
Registry information
Official study title
Deciphering Brain Olfactory Pathways in Prader-Willi Syndrome
Acronym: PRADOL
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Jun 5, 2025
- Registry last updated
- Jun 5, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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