SIRCUS : Social Information pRocessing in Children:an ocUlo-pupillometric Tool for Standard Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 460
- 试验地点
- 2
- 主要终点
- Oculometric measurements 1: Tracking time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •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)
研究组 & 干预措施
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
干预措施: eye-tracker (Other)
Group of children without NDD (NeuroDevelopmental Disorders)
Age between 0 and 12 years
干预措施: eye-tracker (Other)
Group of children with NDD, or whose diagnosis is in progress
Conformity to the diagnostic criteria of NDD
干预措施: eye-tracker (Other)
Group of adult subjects without ASD (Autism Spectrum Disorders)
Age between 18 and 50 years
干预措施: eye-tracker (Other)
Group of children without ASD
Age between 2 and 12 years
干预措施: eye-tracker (Other)
结局指标
主要结局
Oculometric measurements 1: Tracking time
时间窗: 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 3: Fixation time on the eye area during entire stimuli duration
时间窗: 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
Discriminative power
时间窗: 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)
Oculometric measurements 2: Fixation time on the screen
时间窗: 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 4: Fixation time on the mouth area of face stimuli
时间窗: 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
时间窗: 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
次要结局
未报告次要终点