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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Oculometric measurements 1: Tracking time [Срок оценки: through study completion, an average of 1 year (first phase) and of 2 years (second phase)]
• Oculometric measurements 2: Fixation time on the screen [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: through study completion, an average of 1 year (first phase) and of 2 years (second phase)]
• Pupillometric measurements [Срок оценки: through study completion, an average of 1 year (first phase) and of 2 years (second phase)]
• Discriminative power [Срок оценки: through study completion, an average of 1 year (first phase) and of 2 years (second phase)]

Критерии участия

Критерии включения

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

Критерии исключения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Service de Pédopsychiatrie-CHU-TOURS — Tours

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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