Clinical trial NCT05596331: Social Information Processing in Children: an ocUlo-pupillometric Tool for Standard Evaluation
Official title: SIRCUS : Social Information pRocessing in Children:an ocUlo-pupillometric Tool for Standard Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.
name: Laboratory of Fundamental and Applied Computer Science of Tours, EA6300
name: National Research Agency, France
name: Ministry of Health, France
First posted: 2022-10-27
Enrollment: 460
Sex: ALL
Minimum age (years): 1
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Oculometric measurements 1: Tracking time
timeFrame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
measure: Oculometric measurements 2: Fixation time on the screen
timeFrame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
measure: Oculometric measurements 3: Fixation time on the eye area during entire stimuli duration
timeFrame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
measure: Oculometric measurements 4: Fixation time on the mouth area of face stimuli
timeFrame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
measure: Pupillometric measurements
timeFrame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
measure: Discriminative power
timeFrame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: Service de Pédopsychiatrie-CHU-TOURS
Study officials:
affiliation: UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.
name: Nadia Aguillon-Hernandez, MCU
role: PRINCIPAL_INVESTIGATOR
References: