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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02807766
Enrollment
150
Registered
2016-06-21
Start date
2016-05-31
Completion date
2024-12-31
Last updated
2024-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism

Keywords

autism, Brain Plasticity, Behavioral Intervention, Magnetic Resonance Imaging

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.

Interventions

Each group has 30 subjects and experiences six months' training.

BEHAVIORALBehavior modification and sensory integration training

Each group has 30 subjects and experiences six months' training.

BEHAVIORALBehavior modification and applied behavioral analysis

Each group has 30 subjects and experiences six months' training.

BEHAVIORALBehavior modification and TEACCH

Each group has 30 subjects and experiences six months' training.

Sponsors

University of Electronic Science and Technology of China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Brain structural and functional change under behavioral intervention at 6 months in children with autismthrough study completion, an average of 1 yearLongitudinal 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

MeasureTime frameDescription
Prediction model of intervention effect based on multimodal multivariate pattern analysis methodsthrough study completion, an average of 1 yearFirst, 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.

Countries

China

Contacts

Primary ContactHuafu Chen
chenhf@uestc.edu.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026