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

Not Applicable

Recruiting

• Conditions: Autism
• Interventions: Behavioral: Behavior modification and sensory integration training; Behavioral: Behavior modification and TEACCH; Behavioral: Behavior modification and applied behavioral analysis; Behavioral: Behavior modification

• Registration Number: NCT02807766
• Lead Sponsor: University of Electronic Science and Technology of China

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Sensory Integration Training	Behavior modification and sensory integration training	Behavior modification and Sensory Integration Training
TEACCH	Behavior modification and TEACCH	Behavior modification and TEACCH.
applied behavioral analysis	Behavior modification and applied behavioral analysis	Behavior modification and applied behavioral analysis.
Behavior modification	Behavior modification	Behavior modification.

Primary Outcome Measures

Name	Time	Method
Brain structural and functional change under behavioral intervention at 6 months in children with autism	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 Outcome Measures

Name	Time	Method
Prediction model of intervention effect based on multimodal multivariate pattern analysis methods	through study completion, an average of 1 year	First, classify autism individuals into effective treatment group and ineffective treatment group according to the intervention effect at 6 months. Second, conduct feature selection with Sparse optimization algorithms and cluster analysis on MRI data. Third, design optimized classifiers integrated support vector machines and Gaussian Naive Bayes classifiers.

Trial Locations

Locations (2)

Department of Children's and Adolescent Health, Public Health College of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

Center for Information in BioMedicine, Key laboratory for NeuroInformation of Ministry of Education, School of Life Science and Technology, University of Electronic Science and Technology of China; 🇨🇳 Chengdu, Sichuan, China