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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A00870-43 | Registry Identifier | IDRCB |
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| Name | Class |
|---|---|
| UMR 1253, iBrain, Université de Tours, Inserm, Tours, France. | UNKNOWN |
| Laboratory of Fundamental and Applied Computer Science of Tours, EA6300 | UNKNOWN |
| National Research Agency, France | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group of adult subjects without ASD (Autism Spectrum Disorders) | Other | Age between 18 and 50 years |
|
| Group of children without ASD | Other | Age between 2 and 12 years |
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| Group of children with ASD | Other | Age between 2 and 12 years Conformity with the diagnostic criteria of ASD according to DSM-V, ICD-10 or ICD-11 |
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| Group of children without NDD (NeuroDevelopmental Disorders) | Other | Age between 0 and 12 years |
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| Group of children with NDD, or whose diagnosis is in progress | Other | Conformity to the diagnostic criteria of NDD |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eye-tracker | Other | Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity |
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| 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) |
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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
Phase 2
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadia Aguillon-Hernandez, MCU | Contact | 0247478840 | nadia.aguillon@univ-tours.fr | |
| Yosra DRIDI | Contact | +33247479792 | Y.ABDERRAHMEN@chu-tours.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nadia Aguillon-Hernandez, MCU | UMR 1253, iBrain, Université de Tours, Inserm, Tours, France. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Pédopsychiatrie-CHU-TOURS | Recruiting | Tours | 37044 | France |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Ministry of Health, France | OTHER_GOV |
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| through study completion, an average of 1 year (first phase) and of 2 years (second phase) |