Menu
Recruiting NCT05596331

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

No phase Interventional Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: eye-tracker.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder. Basic parameters: 1 Day — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Oculometric measurements 1: Tracking time [Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)]
  • 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)]
  • 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)]
  • 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)]
  • Pupillometric measurements [Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)]
  • Discriminative power [Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Service de Pédopsychiatrie-CHU-TOURS — Tours

Identifiers

NCT: NCT05596331 · DR220031/SIRCUS · 2022-A00870-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗