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NCT Number: NCT05596331

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

1 day–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Pédopsychiatrie-CHU-TOURS

Tours, 37044, France

Location status: Recruiting

Location contact

Nadia AGUILLON-HERNANDEZ, PhD

CONTACT

[email protected]

+33247478840

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

eye-tracker

Other

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

Primary outcomes

  1. Oculometric measurements 1: Tracking time

    Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)

    Mean of tracking time (ms) during entire stimuli duration

  2. Oculometric measurements 2: Fixation time on the screen

    Time frame: through 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

  3. Oculometric measurements 3: Fixation time on the eye area during entire stimuli duration

    Time frame: through 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

  4. Oculometric measurements 4: Fixation time on the mouth area of face stimuli

    Time frame: through 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

  5. Pupillometric measurements

    Time frame: through 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

  6. Discriminative power

    Time frame: through 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Nadia Aguillon-Hernandez, MCU

CONTACT

[email protected]

0247478840

Yosra DRIDI

CONTACT

[email protected]

+33247479792

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • 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.

Registry information

Official study title

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

Acronym: SIRCUS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 27, 2022
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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