Magnetic Resonance Imaging Neuroanatomical Study of Patients with an Autism Spectrum Disorder, Their Relatives and Typically Developing Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- 3DT1 MRI derived variables
研究概览
简要总结
This project is structured around a central study called "Study of genetic factors involved in autism and related conditions ("Genes and Autism" study, sponsor: INSERM). This study explores clinical and genetic aspects of ASD (autism spectrum disorders) and is complemented with several ancillary studies (such as this one) which will use the data of the main study and will allow an extensive review of phenotypes associated with ASD.
In this ancillary study, we will go on the acquisition of anatomical, diffusion and functional MRI in subjects with ASD, relatives and controls. Our group has already performed several neuroanatomical studies of ASD. IWe recruited since 2010 more than 600 subjects (proponents, relatives and controls) to better understand the implication of brain abnormalities in ASD.
This study involves specialized teams in neuroiamging based at INSERM, NeuroSpin (CEA), Robert Debré Hospital (APHP) and Pasteur Institute
Our main objective is to identify structural, connectivity and functional peculiarities in subjects with ASD
Secondary objectives include:
- the identification of familial heritability patterns of ASD
- correlate data obtained in brain imaging with genetic data
- assess specificity and statistical reproducibility of the obtained results
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 24 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for patients:
- •being included in the main study "C16-89 - Study of genetic factors involved in ASD and related disorders"
- •having an ASD fulfilling DSM-5 diagnostic criteria (APA, 2012). Diagnosis will be done by a clinical expert, with the support of structured instruments (ADI-R, ADOS-2)
- •having at least 24 Months
- •being affiliated with the French health insurance
- •having signed the informed consent (by proposant or by legal tutors if the subject is <18 or under legal custody)
- •for relatives
- •being included in the main study "C16-89 - Study of genetic factors involved in ASD and related disorders"
- •having at least 24 Months
- •being affiliated with the French health insurance
- •having signed the informed consent (by proposant or by legal tutors if the subject is <18 or under legal custody)
- •for controls
- •being included in the main study "C16-89 - Study of genetic factors involved in ASD and related disorders"
- •having at least 24 Months
- •being affiliated with the French health insurance
- •having signed the informed consent (by proposant or by legal tutors if the subject is <18 or under legal custody)
- •Non-inclusion criteria:
- •for all subjects
- •severe mental retardation (IQ<35 or developmental age<18 months)
- •medical condition (either psychiatric or physical) not compatible with an inclusion
- •MRI counter indication
- •Current pregnancy or breastfeeding, assessed by questionnaire
- •Not willing to be informed of a brain abnormality diagnosed with MRI
- •for the relatives
- •*discovery of non filiation during the genetic analyses
- •for controls
- •Neurological history (except mental retardation)
- •Personal history of (checked with DIGS for Adults, Diagnostic Interview for Genetic Studies, Numberger et coll., 1994, or Kiddie SADS, Kiddie Schedule for Disorders and Schizophrenia for School Age Children, Orvaschel et coll., 1982): schizophrenia, addiction, bipolar disorder, recurrent depression (> 2 episodes lifetime), severe, not stabilized anxiety disorder, history of episodes of epilepsy, significant inflammatory disease of immunosuppressive medication
排除标准
- •for patients: ASD diagnosis not confirmed by assessments after the inclusion
- •for all subjects: discovery of a counter indication to MRI during the exam (e.g. claustrophobia)
结局指标
主要结局
3DT1 MRI derived variables
时间窗: Day 0
Cortical folding Cortical thickness Cortical surface Cortical, white matter and subcortical volumes
Task based fMRI derived variables
时间窗: Day 0
BOLD activation signals BOLD signal correlations
Resting state fMRI derived variables
时间窗: Day 0
Whole-brain BOLD signal correlations
Diffusion MRI derived variables
时间窗: Day 0
Fractional anisotropy and mean diffusivity NODDI derived variables
quantitative T1 and quantitative T2 MRI
时间窗: Day 0
Myelin Water Fraction
次要结局
未报告次要终点