Social Information Processing in Children: an ocUlo-pupillometric Tool for Standard Evaluation

Study Overview
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Brief Summary
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The goal of this observational study is to identify behavioral and physiological markers of social alterations in Autism Spectrum Disorders compared to Typically Developping peers. This single-centre study plan to use eye tracking to evaluate social disorders in Autism Spectrum Disorders (ASD). The investigators will estimate oculometric and pupillometric indices as potential ASD biomarkers. The study will last 4 years and will be organized in two phases.

Detailed Description
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In a first phase (expected to last 12-16 months), after an experimental validation in typical adults, relevant oculometric and pupillometric indices will be identified in a typical population of children and in a clinically diagnosed population of ASD children. 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.

Official Title
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SIRCUS : Social Information pRocessing in Children:an ocUlo-pupillometric Tool for Standard Evaluation

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Other: eye-tracker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Phase 1 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: Phase 1: All groups have the 2 common exclusion criteria Known uncorrected visual pathologies Known personal neurological pathologies 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)

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group of adult subjects without ASD (Autism Spectrum Disorders)<br>Age between 18 and 50 years | Other: eye-tracker<br>* Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity<br>|
| Other: Group of children without ASD<br>Age between 2 and 12 years | Other: eye-tracker<br>* Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity<br>|
| Other: Group of children with ASD<br>Age between 2 and 12 years Conformity with the diagnostic criteria of ASD according to DSM-V, ICD-10 or ICD-11 | Other: eye-tracker<br>* Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity<br>|
| Other: Group of children without NDD (NeuroDevelopmental Disorders)<br>Age between 0 and 12 years | Other: eye-tracker<br>* Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity<br>|
| Other: Group of children with NDD, or whose diagnosis is in progress<br>Conformity to the diagnostic criteria of NDD | Other: eye-tracker<br>* Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oculometric measurements 1: Tracking time | Mean of tracking time (ms) during entire stimuli duration | through study completion, an average of 1 year (first phase) and of 2 years (second phase) | 
| Oculometric measurements 2: Fixation time on the screen | Mean of fixation time on the screen (ms) during entire stimuli duration | through study completion, an average of 1 year (first phase) and of 2 years (second phase) | 
| Oculometric measurements 3: Fixation time on the eye area during entire stimuli duration | Mean of fixation time on the eye area of face stimuli (ms) during entire stimuli duration | through study completion, an average of 1 year (first phase) and of 2 years (second phase) | 
| Oculometric measurements 4: Fixation time on the mouth area of face stimuli | Mean of fixation time on the mouth area of face stimuli (ms) during entire stimuli duration | through study completion, an average of 1 year (first phase) and of 2 years (second phase) | 
| Pupillometric measurements | Mean of pupil dilation variation(mm) in response to entire stimuli duration | through study completion, an average of 1 year (first phase) and of 2 years (second phase) | 
| Discriminative power | AUROC (Area Under the Receiver Operating Characteristics, in percent) analysis of combined oculometric and pupillometric measurements. Scale score : 0-100% (above 70% : good performance; above 80% : excellent performance; above 90% : outstanding performance) | through study completion, an average of 1 year (first phase) and of 2 years (second phase) |