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Clinical Trials/NCT02807766
NCT02807766
Recruiting
Not Applicable

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

University of Electronic Science and Technology of China2 sites in 1 country150 target enrollmentMay 2016
ConditionsAutism

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism
Sponsor
University of Electronic Science and Technology of China
Enrollment
150
Locations
2
Primary Endpoint
Brain structural and functional change under behavioral intervention at 6 months in children with autism
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
December 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
University of Electronic Science and Technology of China
Responsible Party
Principal Investigator
Principal Investigator

Huafu Chen

professor

University of Electronic Science and Technology of China

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

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

Study Sites (2)

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