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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05596331
Acronym
SIRCUS
Enrollment
460
Registered
2022-10-27
Start date
2023-01-03
Completion date
2026-11-02
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

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.

Interventions

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

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Oculometric measurements 1: Tracking timethrough study completion, an average of 1 year (first phase) and of 2 years (second phase)Mean of tracking time (ms) during entire stimuli duration
Oculometric measurements 2: Fixation time on the screenthrough study completion, an average of 1 year (first phase) and of 2 years (second phase)Mean of fixation time on the screen (ms) during entire stimuli duration
Oculometric measurements 3: Fixation time on the eye area during entire stimuli durationthrough study completion, an average of 1 year (first phase) and of 2 years (second phase)Mean of fixation time on the eye area of face stimuli (ms) during entire stimuli duration
Oculometric measurements 4: Fixation time on the mouth area of face stimulithrough study completion, an average of 1 year (first phase) and of 2 years (second phase)Mean of fixation time on the mouth area of face stimuli (ms) during entire stimuli duration
Pupillometric measurementsthrough study completion, an average of 1 year (first phase) and of 2 years (second phase)Mean of pupil dilation variation(mm) in response to entire stimuli duration
Discriminative powerthrough study completion, an average of 1 year (first phase) and of 2 years (second phase)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)

Countries

France

Contacts

CONTACTNadia Aguillon-Hernandez, MCU
nadia.aguillon@univ-tours.fr0247478840
CONTACTYosra DRIDI
Y.ABDERRAHMEN@chu-tours.fr+33247479792
PRINCIPAL_INVESTIGATORNadia Aguillon-Hernandez, MCU

UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026