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Brain Olfactory Pathways in Prader-Willi Syndrome

ConditionPrader-Willi Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-7
SponsorUniversity Hospital, Toulouse

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • olfactory stimulation

    Other intervention

    the patients have a sniff-test

  • functional MRI

    Other intervention

    patients have a an f MRI

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: OT exposed patientsExperimental treatment 2 interventions
Group B: OT non exposed patientsActive comparator 2 interventions

Trial outcomes

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

Time frame
day 1

Secondary outcomes

1

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

Time frame
day 1
2

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

scores of the eating beahaviour questionnaires

Time frame
day 1
3

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

scores of the sniff test between OT-exposed and non-exposed children.

Time frame
Day 1
4

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

brain connectivity in fMRI between OT-exposed and non-exposed children.

Time frame
day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Toulouse

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: