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

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Other: eye-tracker

Study type: Interventional

Funder types: Other

Identifiers

NCT05596331

2022-A00870-43 (Registry Identifier)

DR220031/SIRCUS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 460 estimated patients

Sex: All

Ages: 1 day to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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460 participants in 5 patient groups

Group of adult subjects without ASD (Autism Spectrum Disorders)

Other group

Description:

Age between 18 and 50 years

Treatment:

Other: eye-tracker

Group of children without ASD

Other group

Description:

Age between 2 and 12 years

Treatment:

Other: eye-tracker

Group of children with ASD

Other group

Description:

Age between 2 and 12 years Conformity with the diagnostic criteria of ASD according to DSM-V, ICD-10 or ICD-11

Treatment:

Other: eye-tracker

Group of children without NDD (NeuroDevelopmental Disorders)

Other group

Description:

Age between 0 and 12 years

Treatment:

Other: eye-tracker

Group of children with NDD, or whose diagnosis is in progress

Other group

Description:

Conformity to the diagnostic criteria of NDD

Treatment:

Other: eye-tracker