Clinical trial NCT02807766: 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
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Keywords: autism
Brain Plasticity
Behavioral Intervention
Magnetic Resonance Imaging
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Brain structural and functional change under behavioral intervention at 6 months in children with autism
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Prediction model of intervention effect based on multimodal multivariate pattern analysis methods
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Harbin
country: China
facility: Department of Children's and Adolescent Health, Public Health College of Harbin Medical University
state: Heilongjiang
city: Chengdu
country: China
facility: 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
state: Sichuan
Study officials:
affiliation: School of Life Science and Technology, University of Electronic Science and Technology of China
name: Huafu Chen
role: PRINCIPAL_INVESTIGATOR
References:
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.