Clinical Trials in France / NCT05596331
Recruiting
Not applicable
Social Information Processing in Children: an ocUlo-pupillometric Tool for Standard Evaluation
NCT05596331 · tracked via the Priya Life Science France tracker
Condition(s) studied
Autism Spectrum Disorder
Investigational drug(s) / intervention(s)
eye-tracker
eye-tracker: Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
Study 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.
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)
Primary outcome measure(s)
- Oculometric measurements 1: Tracking time — 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 - Oculometric measurements 2: Fixation time on the screen — 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 - Oculometric measurements 3: Fixation time on the eye area during entire stimuli duration — 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 - Oculometric measurements 4: Fixation time on the mouth area of face stimuli — 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 - Pupillometric measurements — 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 - Discriminative power — 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)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Service de Pédopsychiatrie-CHU-TOURS | Tours | France | Recruiting |
More University Hospital, Tours trials in France
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05596331 on ClinicalTrials.gov ↗ ← All trials in France