跳至主要内容
临床试验/NCT06334588
NCT06334588招募中不适用

Understanding the Mechanisms of Autism : an MRI and Social Cognition Study

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
2
主要终点
Rest cerebral blood flow (CBF)

研究概览

简要总结

The main goal of this study is to investigate anatomo-functional brain abnormalities associated with autism spectrum disorders using a multimodal brain imaging approach, as well as its links to social cognition difficulties measured using eye-tracking

详细描述

Autism Spectrum Disorders (ASD) are neurodevelopmental disorders whose first manifestations appear early in childhood. Even if ASDs present a wide heterogeneity in clinical manifestations, abnormalities in social behavior, characterized in particular by a lack of preference for social information, remain the core of difficulties characteristic of autism.

Brain imaging investigations have revealed anatomo-functional abnormalities in autism, particularly in social brain regions. In parallel, eye-tracking studies have provided objective measures of social perception abnormalities in autism. These results illustrate the relevance of these research strategies in the context of ASD. Acquiring objective data on social behavior and linking them with brain imaging data opens up new avenues for research into the evolution of social skills during child development, and the brain changes underlying this process.

In this context, the main hypothesis of this study is that the investigation of the neural bases of autism spectrum disorders, using an approach combining multimodal brain imaging and the investigation of social behavior using eye-tracking, would make it possible not only to better describe abnormalities, but also to identify individual patterns at brain and behavioral level. This could help to better characterize ASDs with and without genetic abnormalities, an area which to date has received very little investigation. In addition, the objective measurements obtained with this approach would also enable the proposal of biomarkers, which would contribute not only to better monitoring of the disorder's evolution, but also to the evaluation of the effectiveness of new therapeutic interventions

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
3 Months 至 28 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • For subjects diagnosed with ASD or suspected of ASD :
  • 3 months ≤ age < 25 years ;
  • an MRI required as part of the clinical procedures
  • written consent obtained from parents or legal guardians.
  • Affiliated to social security
  • For Healthy control subjects over 3 years of age:
  • between 3 and 28 years of age
  • no known neurological or psychiatric pathology
  • written consent obtained from parents or legal guardian.
  • Affiliated to social security
  • For Healthy control subjects under 5 years of age:
  • age between 3 months and 5 years
  • who have had an MRI scan in the pediatric radiology department at Necker Hospital, which was found to be normal.
  • with no known neurological or psychiatric pathology
  • no opposition from legal representative

排除标准

  • Contraindication to MRI (pacemaker, intracorporeal metallic body, claustrophobia).
  • Impossibility for healthy volunteers to remain still during MRI

结局指标

主要结局

Rest cerebral blood flow (CBF)

时间窗: at inclusion

Whole brain rest CBF measured with Arterial spin labelling MRI

次要结局

  • Measurements of white matter microstructure - mean diffusivity(at inclusion)
  • Measurements of white matter microstructure - fractional anisotropy(at inclusion)
  • Correlation between social perception and multimodal brain imaging(at inclusion)
  • Imaging abnormalities associated with known genetic mutations(at inclusion)
  • Anatomic changes over time - study of developmental trajectory(2 years)
  • Social perception changes over time - study of developmental trajectory(2 years)
  • Early data on social perception(at inclusion)
  • Measurements of white matter microstructure - axial diffusivity(at inclusion)
  • Correlation between clinical severity and multimodal brain imaging(at inclusion)
  • Measurements of white matter microstructure - radial diffusivity(at inclusion)
  • Measurements of resting state functional connectivity(at inclusion)
  • Social perception abnormalities associated with known genetic mutations(at inclusion)
  • Brain imaging in young children associated with ASD(at inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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