跳至主要内容
临床试验/NCT02807766
NCT02807766招募中不适用

Brain Plasticity of Autism in Response to Early Behavioral Intervention: A Multimodal MRI Study

University of Electronic Science and Technology of China2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
2
主要终点
Brain structural and functional change under behavioral intervention at 6 months in children with autism

研究概览

简要总结

Autism is a well-recognized neurodevelopmental disorder severely affecting the health of children. While the unclear neurobiological basis of autism and the lack of effective medication, the most commonly used approach for treatment is behavioral intervention. However, the pathophysiological mechanisms underlying the intervention therapy remains incompletely understood. The current project aims to explore the impacts of different early behavioral intervention methods on brain plasticity of autism using multimodal MRI technique and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods.

详细描述

Autism is a well-recognized neurodevelopmental disorder severely affecting the health of children. While the unclear neurobiological basis of autism and the lack of effective medication, the most commonly used approach for treatment is behavioral intervention. However, the pathophysiological mechanisms underlying the intervention therapy remains incompletely understood. The current project aims to explore the impacts of different early behavioral intervention methods on brain plasticity of autism using multimodal MRI technique and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods. Investigators collect participants' brain imaging data, eye movement data, stool samples and clinical scale score before and after intervention. Investigators first investigate longitudinal effect of behavioral intervention on brain structure and function in children with autism. In addition, investigators provide new biological indexes upon multimodal large-scale brain connectomes to evaluate the curative effect of intervention. Finally, investigators propose a prediction model of intervention effect based on multimodal multivariate pattern analysis methods. Furthermore, investigators expect to map the state-of-the-art biomarkers on multi-modal networks to provide a new interpretation of pathophysiological mechanisms of autism.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
2 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age range from 2 to 8 years old.
  • Clinical DSM-IV diagnosis of autism.

排除标准

  • Subjects with other neurodevelopmental diseases.
  • Subjects with contraindications to MRI.

结局指标

主要结局

Brain structural and functional change under behavioral intervention at 6 months in children with autism

时间窗: through study completion, an average of 1 year

Longitudinal effect of behavioral intervention on brain structure and function in children with autism will be assessed by Voxel-based morphometry analysis for structural changes, as well as Regional homogeneity, Amplitude of low-frequency fluctuation, etc, for functional changes.

次要结局

  • Prediction model of intervention effect based on multimodal multivariate pattern analysis methods(through study completion, an average of 1 year)

研究者

发起方
University of Electronic Science and Technology of China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Huafu Chen

professor

University of Electronic Science and Technology of China

研究点 (2)

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