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

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02807766
• Other study ID #: UESTC-chenhuafulab-001
• Status: Recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: University of Electronic Science and Technology of China
• Contact: Huafu Chen
• Email: chenhf[@]uestc.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Behavioral:
• Behavior modification
Each group has 30 subjects and experiences six months' training.
• Behavior modification and sensory integration training
Each group has 30 subjects and experiences six months' training.
• Behavior modification and applied behavioral analysis
Each group has 30 subjects and experiences six months' training.
• Behavior modification and TEACCH
Each group has 30 subjects and experiences six months' training.

Locations

Country	Name	City	State
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	Department of Children's and Adolescent Health, Public Health College of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
University of Electronic Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year