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

Not Applicable

Recruiting

• Conditions: Autism Spectrum Disorder

• 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.

Study Timeline

• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-27
• Study Start: 2023-01-03
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-05
• Primary Completion: 2026-01-03
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 460

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Trial Locations

Locations (1)

Service de Pédopsychiatrie-CHU-TOURS; 🇫🇷 Tours, France