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

Autism Spectrum Disorder Clinical Trial

— SIRCUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05596331
• Other study ID #: DR220031/SIRCUS
• Secondary ID: 2022-A00870-43
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: September 2026

Study information

• Verified date: December 2023
• Source: University Hospital, Tours
• Contact: Nadia Aguillon-Hernandez, MCU
• Phone: 0247478840
• Email: nadia.aguillon[@]univ-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: September 2026
• Est. primary completion date: January 3, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Other:
• eye-tracker
Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity

Locations

Country	Name	City	State
France	Service de Pédopsychiatrie-CHU-TOURS	Tours

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Tours	Laboratory of Fundamental and Applied Computer Science of Tours, EA6300, Ministry of Health, France, National Research Agency, France, UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oculometric measurements 1: Tracking time	Mean of tracking time (ms) during entire stimuli duration	through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Primary	Oculometric measurements 2: Fixation time on the screen	Mean of fixation time on the screen (ms) during entire stimuli duration	through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Primary	Oculometric measurements 3: Fixation time on the eye area during entire stimuli duration	Mean of fixation time on the eye area of face stimuli (ms) during entire stimuli duration	through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Primary	Oculometric measurements 4: Fixation time on the mouth area of face stimuli	Mean of fixation time on the mouth area of face stimuli (ms) during entire stimuli duration	through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Primary	Pupillometric measurements	Mean of pupil dilation variation(mm) in response to entire stimuli duration	through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Primary	Discriminative power	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)	through study completion, an average of 1 year (first phase) and of 2 years (second phase)