ClinicalTrials.gg
Not yet recruitingNCT07006207PRADOLUpdated Jun 5, 2025

Brain Olfactory Pathways in Prader-Willi Syndrome

An interventional study of olfactory stimulation and functional MRI in Prader-Willi Syndrome, sponsored by University Hospital, Toulouse. Not yet recruiting at 1 site in France. Open to participants aged 5 Years to 7 Years. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
5 Years to 7 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 17 studies in Prader-Willi Syndrome by University Hospital, Toulouse — 6 open to participants now, 6 under way, 1 of them phase 3. Prader-Willi Syndrome · University Hospital, Toulouse.

Planned enrollment
9th of 14
30 · median 37
Started
2025
with 1 other
No phase
6 of 17
2 open now
Registered
17th of 17
by date

Among the 17 studies in Prader-Willi Syndrome by University Hospital, Toulouse, this one is the 9th largest by planned enrollment of the 14 interventional ones that give a count, is one of 2 that started in 2025, is one of 6 with no phase, and was the 17th registered.

Prader-Willi Syndrome

144 studies on the registry are indexed under Prader-Willi Syndrome; 23 are open to participants now.

Browse Prader-Willi Syndrome studies →

Open to participants now

6 of the 17 studies in Prader-Willi Syndrome by University Hospital, Toulouse are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Who these studies take

Of the 16 Prader-Willi Syndrome studies recruiting now, 7 (44%) set no upper age limit and 9 (56%) stop at 75 or younger; 11 take children under 18; 1 take healthy volunteers.

This study: 5 Years to 7 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study summary

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.

03

Conditions studied

  • Prader-Willi Syndrome

Browse trials for

Keywords

  • cerebral activity
  • Olfactory activation
04

Who can participate

Ages eligible
5 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Presence of a 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    OT exposed patients

    children OT exposed have olfactory test and fMRI

    Other: olfactory stimulation · Other: functional MRI

  • Active comparator
    OT non exposed patients

    children non- OT exposed have olfactory test and fMRI

    Other: olfactory stimulation · Other: functional MRI

Interventions

  • Otherolfactory stimulation

    the patients have a sniff-test

  • Otherfunctional MRI

    patients have a an f MRI

06

What researchers measure

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

07

Study locations

1 site
  • University Hospital
    Toulouse, 31059, France
    • Gwenaelle DIENE, MD · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2025; primary completion for Dec 2025, 6 months later.

Of 19 interventional studies with no phase under Prader-Willi Syndrome, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 43. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2025
First posted
Jun 5, 2025
StartEst.
Jun 23, 2025
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
Jun 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07006207
Responsible party
Sponsor
First posted
Jun 5, 2025
Start date
Jun 23, 2025 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jun 5, 2025

Study contacts

Julie CORTADELLAS
Contact
cortadellas.j@chu-toulouse.fr
0534557635
Nadege ALGANS
Contact
algans.n@chu-toulouse.fr
0561777204
Gwenaelle DIENE, MD
principal investigator · University Hospital of Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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