Prader-Willi SyndromePRADOLNCT07006207
Brain Olfactory Pathways in Prader-Willi Syndrome
A study testing olfactory stimulation and functional MRI in people with Prader-Willi Syndrome, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Studying the cerebral activity of children with Prader-Willi Syndrom (PWS) when the study propose to them nasal activations. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Prader-Willi Syndrome
- What is being tested?
- olfactory stimulation and functional MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Deciphering 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.
Read the 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.
- Conditions
- Prader-Willi Syndrome
- Being tested
- olfactory stimulation, functional MRI
- Keywords
- cerebral activity, Olfactory activation
- Medical subject headings
- Prader-Willi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olfactory stimulationOther
the patients have a sniff-test
functional MRIOther
patients have a an f MRI
| Study group | Role | What they receive |
|---|---|---|
| OT exposed patients | Experimental | children OT exposed have olfactory test and fMRI Receives: Other: olfactory stimulation; Other: functional MRI |
| OT non exposed patients | Active comparator | children non- OT exposed have olfactory test and fMRI Receives: Other: olfactory stimulation; Other: functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1
Secondary outcomes (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.
intensity of right amygdala in fMRI
Measured: day 1
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
Measured: 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.
Measured: 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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start23 Jun 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwenaelle DIENE, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006207
- Sponsor's protocol ID
- RC31/23/0653
- Acronym
- PRADOL
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering Brain Olfactory Pathways in Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT07006207
- Acronym / sponsor ID
- PRADOL / RC31/23/0653
- Conditions
- Prader-Willi Syndrome
- Keywords
- cerebral activity, Olfactory activation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 23 Jun 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OT exposed patients | Experimental | Other: olfactory stimulation, Other: functional MRIchildren OT exposed have olfactory test and fMRI |
| OT non exposed patients | Active comparator | Other: olfactory stimulation, Other: functional MRIchildren non- OT exposed have olfactory test and fMRI |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olfactory stimulationthe patients have a sniff-test | Other | OT exposed patients, OT non exposed patients |
| functional MRIpatients have a an f MRI | Other | OT exposed patients, OT non exposed patients |
Primary outcome
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
4 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gwenaelle DIENE, MD principal investigator
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing olfactory stimulation and functional MRI in people with Prader-Willi Syndrome, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie CORTADELLAS (0534557635, cortadellas.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.