Therapeutic Intervention Effects of rTMS on Children With Autism Spectrum Disorder

Study Overview
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Brief Summary
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Autism spectrum disorder (ASD) is a common and complex neurodevelopmental disorder, which is characterized by impairments of social communication, social reciprocity, as well as restricted and repetitive behaviors (RRB). The unclear pathogenesis of ASD, its increasing prevalence, and its poor clinical diagnosis and treatment effect have caused a serious economic and mental burden on patients and their families. As a new non-invasive neuroelectrophysiological technique, transcranial magnetic stimulation (TMS) has been used more and more in the interventional treatment of autism. The current project aims to explore the influence of TMS on brain plasticity in autism by using TMS for interventional treatment of autism and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods.

Detailed Description
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Autism spectrum disorder (ASD) is a common and complex neurodevelopmental disorder, which is characterized by impairments of social communication, social reciprocity, as well as restricted and repetitive behaviors (RRB). The unclear pathogenesis of ASD, its increasing prevalence, and its poor clinical diagnosis and treatment effect have caused a serious economic and mental burden on patients and their families. As a new non-invasive neuroelectrophysiological technique, transcranial magnetic stimulation (TMS) has been used more and more in the interventional treatment of autism. The current project aims to explore the influence of TMS on brain plasticity in autism by using TMS for interventional treatment of autism and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods. Investigators conduct a randomized, double-blind, controlled TMS trial and collect the participants' stool samples and sequence the gut microbiome before the first magnetic resonance imaging(MRI) scan. Besides, investigators collect brain imaging data, eye movement data and clinical scale score before and after TMS trial to explore the changes of TMS treatment on clinical behavior and brain plasticity and provide guidelines for the intervention and treatment of autism.

Official Title
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Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Neural Mechanisms and Cognitive Functions of Children With Autism Spectrum Disorder

Conditions
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Autism

Intervention / Treatment
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* Device: Applied high amplitude repeated transcranial magnetic stimulation
* Device: Applied low amplitude repeated transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High amplitude repeated transcranial magnetic stimulation<br>Applied high amplitude repeated transcranial magnetic stimulation | Device: Applied high amplitude repeated transcranial magnetic stimulation<br>* Each mode required 20 stimuli(100%RMT) for 20 minutes each time, 5 times a week<br>|
| Experimental: Low amplitude repeated transcranial magnetic stimulation<br>Applied low amplitude repeated transcranial magnetic stimulation | Device: Applied low amplitude repeated transcranial magnetic stimulation<br>* Each mode required 20 stimuli(15%RMT) for 20 minutes each time, 5 times a week<br>|
| No Intervention: healthy control group<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The gray matter volume of children with autism at baseline and after repeated transcranial magnetic stimulation intervention as assessed by magnetic resonance imaging. | Longitudinal study of the gray matter volume will be conducted in children with autism at baseline and after repeated transcranial magnetic stimulation intervention based on structural magnetic resonance image. Longitudinal effect of repeated transcranial magnetic stimulation intervention on brain structure in children with autism will be assessed by Voxel-based morphometry analysis for gray matter volume changes. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The functional connectivity of whole brain of whole brain in children with autism with repeated transcranial magnetic stimulation intervention as assessed by functional magnetic resonance imaging. | Longitudinal study of the functional connectivity will be conducted in children with autism at baseline and after repeated transcranial magnetic stimulation intervention based on resting-state functional magnetic resonance image | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autism, Brain Plasticity, transcranial magnetic stimulation, Magnetic Resonance Imaging, eye movement, gut microbiome