Brain Plasticity of Autism in Response to Early Behavioral Intervention: A Multimodal MRI Study
Primary Purpose
Autism
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Behavior modification
Behavior modification and sensory integration training
Behavior modification and applied behavioral analysis
Behavior modification and TEACCH
Sponsored by
About this trial
This is an interventional basic science trial for Autism focused on measuring autism, Brain Plasticity, Behavioral Intervention, Magnetic Resonance Imaging
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.
Sites / Locations
- Department of Children's and Adolescent Health, Public Health College of Harbin Medical UniversityRecruiting
- 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 ChinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Other
No Intervention
Arm Label
Sensory Integration Training
applied behavioral analysis
TEACCH
Behavior modification
healthy control group
Arm Description
Behavior modification and Sensory Integration Training
Behavior modification and applied behavioral analysis.
Behavior modification and TEACCH.
Behavior modification.
No intervention.
Outcomes
Primary Outcome Measures
Brain structural and functional change under behavioral intervention at 6 months in children with autism
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
Prediction model of intervention effect based on multimodal multivariate pattern analysis methods
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.
Full Information
NCT ID
NCT02807766
First Posted
June 13, 2016
Last Updated
January 14, 2020
Sponsor
University of Electronic Science and Technology of China
1. Study Identification
Unique Protocol Identification Number
NCT02807766
Brief Title
Brain Plasticity of Autism in Response to Early Behavioral Intervention: A Multimodal MRI Study
Official Title
Brain Plasticity of Autism in Response to Early Behavioral Intervention: A Multimodal MRI Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Electronic Science and Technology of China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
autism, Brain Plasticity, Behavioral Intervention, Magnetic Resonance Imaging
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sensory Integration Training
Arm Type
Experimental
Arm Description
Behavior modification and Sensory Integration Training
Arm Title
applied behavioral analysis
Arm Type
Experimental
Arm Description
Behavior modification and applied behavioral analysis.
Arm Title
TEACCH
Arm Type
Experimental
Arm Description
Behavior modification and TEACCH.
Arm Title
Behavior modification
Arm Type
Other
Arm Description
Behavior modification.
Arm Title
healthy control group
Arm Type
No Intervention
Arm Description
No intervention.
Intervention Type
Behavioral
Intervention Name(s)
Behavior modification
Intervention Description
Each group has 30 subjects and experiences six months' training.
Intervention Type
Behavioral
Intervention Name(s)
Behavior modification and sensory integration training
Intervention Description
Each group has 30 subjects and experiences six months' training.
Intervention Type
Behavioral
Intervention Name(s)
Behavior modification and applied behavioral analysis
Intervention Description
Each group has 30 subjects and experiences six months' training.
Intervention Type
Behavioral
Intervention Name(s)
Behavior modification and TEACCH
Intervention Description
Each group has 30 subjects and experiences six months' training.
Primary Outcome Measure Information:
Title
Brain structural and functional change under behavioral intervention at 6 months in children with autism
Description
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.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Prediction model of intervention effect based on multimodal multivariate pattern analysis methods
Description
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.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huafu Chen
Email
chenhf@uestc.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huafu Chen
Organizational Affiliation
School of Life Science and Technology, University of Electronic Science and Technology of China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Children's and Adolescent Health, Public Health College of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150086
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijie Wu
Email
wangjiahyd@163.com
Facility Name
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
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610054
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huafu Chen
Email
chenhf@uestc.edu.cn
First Name & Middle Initial & Last Name & Degree
Huafu Chen
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33123725
Citation
Guo X, Duan X, Suckling J, Wang J, Kang X, Chen H, Biswal BB, Cao J, He C, Xiao J, Huang X, Wang R, Han S, Fan YS, Guo J, Zhao J, Wu L, Chen H. Mapping Progressive Gray Matter Alterations in Early Childhood Autistic Brain. Cereb Cortex. 2021 Feb 5;31(3):1500-1510. doi: 10.1093/cercor/bhaa304.
Results Reference
derived
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Brain Plasticity of Autism in Response to Early Behavioral Intervention: A Multimodal MRI Study
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