Evaluating social processing in children with Autism using eye tracking

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

This study is testing how children with Autism see and respond to social situations using eye tracking to find signs that could help understand their social challenges better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 460 (estimated)
• Ages: 1 Day to 50 Years
• Sex: All
• Sponsor: University Hospital, Tours (other)
• Locations: 1 site (Tours)
• Trial ID: NCT05596331 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify behavioral and physiological markers of social alterations in children with Autism Spectrum Disorder (ASD) compared to typically developing peers. The study will utilize eye tracking technology to evaluate social disorders, estimating oculometric and pupillometric indices as potential biomarkers for ASD. It will be conducted in two phases over four years, with the first phase focusing on experimental validation in typical children and adults, and the second phase testing identified biomarkers on a larger population including other neurodevelopmental disorders.

Who should consider this trial

Good fit: Ideal candidates include children aged 2 to 12 years with a clinical diagnosis of Autism Spectrum Disorder or typically developing children within the same age range.

Not a fit: Patients with known uncorrected visual pathologies or personal neurological pathologies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the development of objective biomarkers for diagnosing and evaluating Autism Spectrum Disorder.

How similar studies have performed: While the use of eye tracking in evaluating social processing is gaining traction, this specific approach to identifying biomarkers in ASD is relatively novel and has not been extensively tested.

Eligibility criteria

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)

Where this trial is running

Tours

• Service de Pédopsychiatrie-CHU-TOURS — Tours, France (RECRUITING)

Study contacts

• Principal investigator: Nadia Aguillon-Hernandez, MCU — UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.
• Study coordinator: Nadia Aguillon-Hernandez, MCU

Conditions: Autism Spectrum Disorder