Social Information Processing in Children: an ocUlo-pupillometric Tool for Standard Evaluation
NCT ID: NCT05596331
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
460 participants
INTERVENTIONAL
2023-01-03
2026-09-30
Brief Summary
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Detailed Description
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In a second phase of the protocol (expected to last 32-36 months), biomarkers identified in the first phase will be tested on a larger population including other neurodevelopmental disorders.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Group of adult subjects without ASD (Autism Spectrum Disorders)
Age between 18 and 50 years
eye-tracker
Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
Group of children without ASD
Age between 2 and 12 years
eye-tracker
Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
Group of children with ASD
Age between 2 and 12 years Conformity with the diagnostic criteria of ASD according to DSM-V, ICD-10 or ICD-11
eye-tracker
Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
Group of children without NDD (NeuroDevelopmental Disorders)
Age between 0 and 12 years
eye-tracker
Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
Group of children with NDD, or whose diagnosis is in progress
Conformity to the diagnostic criteria of NDD
eye-tracker
Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
Interventions
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eye-tracker
Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
Eligibility Criteria
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Inclusion Criteria
All groups have these 2 criteria in common:
Free, informed and signed consent of both parents Enrolment in the social security system
The other criteria per group are as follows:
Group of adult subjects without ASD : Age between 18 and 50 years Group of children without ASD
* Age between 2 and 12 years
* Group of children with ASD Age between 2 and 12 years Conformity with the diagnostic criteria of ASD according to DSM-V, ICD-10 or ICD-11
Phase 2
* Group of children without TND : Age between 0 and 12 years
* Group of children with TND, or whose diagnosis is in progress (via PCO referral) :
Age between 0 and 12 years Conformity to the diagnostic criteria of TND
Exclusion Criteria
And they have these criteria per group:
* Group of adult subjects without ASD: Subject under guardianship or trusteeship Diagnosis of ASD Group of children without ASD : Diagnosis of ASD
* Group of children with ASD ICD-10 diagnosis of PDD (Rett syndrome and Hayler syndrome) Phase 2
* Group of children without ASD : Diagnosis of ASD (confirmed or ongoing)
1 Day
50 Years
ALL
Yes
Sponsors
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UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.
UNKNOWN
Laboratory of Fundamental and Applied Computer Science of Tours, EA6300
UNKNOWN
National Research Agency, France
OTHER
Ministry of Health, France
OTHER_GOV
University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Nadia Aguillon-Hernandez, MCU
Role: PRINCIPAL_INVESTIGATOR
UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.
Locations
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Service de Pédopsychiatrie-CHU-TOURS
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Nadia AGUILLON-HERNANDEZ, PhD
Role: primary
Other Identifiers
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2022-A00870-43
Identifier Type: REGISTRY
Identifier Source: secondary_id
DR220031/SIRCUS
Identifier Type: -
Identifier Source: org_study_id