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

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ClinicalTrials.gov Identifier: NCT02807766
Recruitment Status : Unknown
Verified November 2016 by chenhuafu, University of Electronic Science and Technology of China.
Recruitment status was:  Recruiting
First Posted : June 21, 2016
Last Update Posted : November 10, 2016
Sponsor:
Information provided by (Responsible Party):
chenhuafu, 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.

Condition or disease Intervention/treatment Phase
Autism Behavioral: Behavior modification Behavioral: Behavior modification and sensory integration training Behavioral: Behavior modification and applied behavioral analysis Behavioral: Behavior modification and TEACCH Not Applicable

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 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Brain Plasticity of Autism in Response to Early Behavioral Intervention: A Multimodal MRI Study
Study Start Date : May 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Sensory Integration Training
Behavior modification and Sensory Integration Training
Behavioral: Behavior modification and sensory integration training
Each group has 30 subjects and experiences six months' training.

Experimental: applied behavioral analysis
Behavior modification and applied behavioral analysis.
Behavioral: Behavior modification and applied behavioral analysis
Each group has 30 subjects and experiences six months' training.

Experimental: TEACCH
Behavior modification and TEACCH.
Behavioral: Behavior modification and TEACCH
Each group has 30 subjects and experiences six months' training.

Behavior modification
Behavior modification.
Behavioral: Behavior modification
Each group has 30 subjects and experiences six months' training.

No Intervention: healthy control group
No intervention.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Prediction model of intervention effect based on multimodal multivariate pattern analysis methods [ Time Frame: 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.



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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807766


Contacts
Contact: Huafu Chen chenhf@uestc.edu.cn

Locations
China, Heilongjiang
Department of Children's and Adolescent Health, Public Health College of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150086
Contact: Lijie Wu       wangjiahyd@163.com   
China, Sichuan
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 Recruiting
Chengdu, Sichuan, China, 610054
Contact: Huafu Chen       chenhf@uestc.edu.cn   
Principal Investigator: Huafu Chen         
Sponsors and Collaborators
University of Electronic Science and Technology of China
Investigators
Principal Investigator: Huafu Chen School of Life Science and Technology, University of Electronic Science and Technology of China

Responsible Party: chenhuafu, professor, University of Electronic Science and Technology of China
ClinicalTrials.gov Identifier: NCT02807766     History of Changes
Other Study ID Numbers: UESTC-chenhuafulab-001
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by chenhuafu, University of Electronic Science and Technology of China:
autism
Brain Plasticity
Behavioral Intervention
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders