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临床试验/NCT06908174
NCT06908174招募中不适用

Differences in Prosocial Behaviors and Related Brain Networks in Children With Autism and Typical Development

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年4月7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
300
试验地点
1
主要终点
clinical diagnosis

研究概览

简要总结

The goal of this observational study is to compare the brain functional network between children with autism and typical development, using magnetic resonance imaging (MRI), electroencephalogram/event-related potentials(EEG/ERPs) and functional Near Infrared Spectrum(fNIRs). The main questions it aims to answer are as follows: 1. What are the differences of the functional brain network between autism and TD children? 2. What are the differences of the brain activity in response to special social stimulus between autism and TD children? Participants will receive developmental/intelligence assessments (Griffiths Mental Developmental Scales/Wechsler Preschool and Primary Scale of Intelligence-IV/Wechsler Intelligence Scale for Children-IV for children of different ages), social assessments(Autism Diagnostic Observation Schedule-2nd Edition/Social Communication Questionnaire), EEG/ERPs and fNIRs in resting and task states, and head MRI in natural sleeping state(without sedative).

详细描述

The cross-sectional observational study will be performed to compare the differences of functional brain network and reactions to social stimulus between children with autism and typical development. The investigators will recruit children aged between 2 to 17 years and 11 months old. They need to receive the mentioned assessments and medical examinations for at least once.

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
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children diagnosed with ASD according to a clinical judgement based on the criteria of ASD in DSM-5 and further confirmed with ADOS-2;
  • •Ages 2-17 years;
  • •Parents/caregivers understand the content of the study and agree to participate in.

排除标准

  • •Rett Syndrome, Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, tuberous sclerosis, and other syndromes caused by known genetic defects or inherited metabolic diseases;
  • •Children with brain injuries, specific chronic or congenital diseases.
  • •The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.
  • •Children cannot receive the head MRI examination.
  • •Control group:
  • •Inclusion Criteria:
  • •Healthy children age between 2 to 17 years.
  • •Children without the family history of ASD or other neurodevelopmental/mental diseases.
  • •Parents/caregivers understand the content of the study and agree to participate in.
  • •Exclusion Criteria:
  • •Children with brain injuries, specific chronic or congenital diseases.
  • •The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.
  • •Children cannot receive the head MRI examination.

结局指标

主要结局

clinical diagnosis

时间窗: Baseline (during 2 to 17 years old).

Clinicians will diagnose subjects as ASD, other neurodevelopmental disorders, or typical developing children, using DSM-5 and ADOS-2. The minimum and maximum scores of ADOS-2 are 0 and 28, and the comparison score of ADOS-2 ranges from 1 to 10, in which higher scores mean a worse outcome.

Latencies in event related potentials(ERPs)

时间窗: Baseline (during 2 to 17 years old).

The investigators will explore the differences of N1/N2, P3/LPP and N400 in event related potentials (ERPs) between case and control groups (children with ASD and typical development) in responses to special prosocial stimulus, and also in false belief tasks. Event related potentials (ERPs) will be tested using eego™ mylab of ANT Neuro company.

Amplitudes in ERPs

时间窗: Baseline (during 2 to 17 years old).

Amplitudes of N1/N2, P3/LPP and N400 will be compared between children with autism spectrum disorder and typical development.

nuclear magnetic resonance imaging(MRI)

时间窗: Baseline (during 2 to 17 years old).

Cranial MRI data, including sMRI and fMRI, will be collected during subjects are in natural asleep or awake, using uMR 890 3T of United Imaging company.

Changes in the concentrations of Oxygenated Hemoglobin (HbO) and deoxygenated Hemoglobin (HbR) during interactions

时间窗: Baseline (during 2 to 17 years old).

The investigators will explore inter-group differences of children with ASD and typical development in the concentrations of HbO and HbR during social communication scenes between participants and investigators.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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