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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: eye-tracker

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 Type: Interventional
• Enrollment (Estimated): 460
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadia Aguillon-Hernandez, MCU; Phone Number: 0247478840; Email: nadia.aguillon@univ-tours.fr
• Study Contact Backup: Name: Yosra DRIDI; Phone Number: +33247479792; Email: Y.ABDERRAHMEN@chu-tours.fr

Study Locations

• France
  • Tours, France, 37044
    • Recruiting
    • Service de Pédopsychiatrie-CHU-TOURS
    • Contact: Nadia AGUILLON-HERNANDEZ, PhD; Phone Number: +33247478840; Email: nadia.aguillon@univ-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group of adult subjects without ASD (Autism Spectrum Disorders); Age between 18 and 50 years	Other: eye-tracker; Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
Other: Group of children without ASD; Age between 2 and 12 years	Other: eye-tracker; Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
Other: 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	Other: eye-tracker; Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
Other: Group of children without NDD (NeuroDevelopmental Disorders); Age between 0 and 12 years	Other: eye-tracker; Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
Other: Group of children with NDD, or whose diagnosis is in progress; Conformity to the diagnostic criteria of NDD	Other: eye-tracker; Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Collaborators: Ministry of Health, France; National Research Agency, France; UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.; Laboratory of Fundamental and Applied Computer Science of Tours, EA6300
• Investigators: Principal Investigator: Nadia Aguillon-Hernandez, MCU, UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Estimated): January 3, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: DR220031/SIRCUS; 2022-A00870-43 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No