Social Information Processing in Children: an ocUlo-pupillometric Tool for Standard Evaluation
- Conditions
- Autism Spectrum Disorder
- Interventions
- Other: eye-tracker
- Registration Number
- NCT05596331
- Lead Sponsor
- University Hospital, Tours
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 460
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
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group of children without NDD (NeuroDevelopmental Disorders) eye-tracker Age between 0 and 12 years Group of adult subjects without ASD (Autism Spectrum Disorders) eye-tracker Age between 18 and 50 years Group of children with NDD, or whose diagnosis is in progress eye-tracker Conformity to the diagnostic criteria of NDD Group of children with ASD eye-tracker Age between 2 and 12 years Conformity with the diagnostic criteria of ASD according to DSM-V, ICD-10 or ICD-11 Group of children without ASD eye-tracker Age between 2 and 12 years
- Primary Outcome Measures
Name Time Method Oculometric measurements 1: Tracking time through study completion, an average of 1 year (first phase) and of 2 years (second phase) Mean of tracking time (ms) during entire stimuli duration
Oculometric measurements 3: Fixation time on the eye area during entire stimuli duration through study completion, an average of 1 year (first phase) and of 2 years (second phase) Mean of fixation time on the eye area of face stimuli (ms) during entire stimuli duration
Oculometric measurements 2: Fixation time on the screen through study completion, an average of 1 year (first phase) and of 2 years (second phase) Mean of fixation time on the screen (ms) during entire stimuli duration
Discriminative power through study completion, an average of 1 year (first phase) and of 2 years (second phase) 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)
Oculometric measurements 4: Fixation time on the mouth area of face stimuli through study completion, an average of 1 year (first phase) and of 2 years (second phase) Mean of fixation time on the mouth area of face stimuli (ms) during entire stimuli duration
Pupillometric measurements through study completion, an average of 1 year (first phase) and of 2 years (second phase) Mean of pupil dilation variation(mm) in response to entire stimuli duration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Service de PĂ©dopsychiatrie-CHU-TOURS
🇫🇷Tours, France