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Therapeutic Intervention Effects of rTMS on Children With Autism Spectrum Disorder

Not Applicable
Recruiting
Conditions
Autism
Interventions
Device: Applied low amplitude repeated transcranial magnetic stimulation
Device: Applied high amplitude repeated transcranial magnetic stimulation
Registration Number
NCT05140356
Lead Sponsor
University of Electronic Science and Technology of China
Brief Summary

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

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
60
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Low amplitude repeated transcranial magnetic stimulationApplied low amplitude repeated transcranial magnetic stimulationApplied low amplitude repeated transcranial magnetic stimulation
High amplitude repeated transcranial magnetic stimulationApplied high amplitude repeated transcranial magnetic stimulationApplied high amplitude repeated transcranial magnetic stimulation
Primary Outcome Measures
NameTimeMethod
The gray matter volume of children with autism at baseline and after repeated transcranial magnetic stimulation intervention as assessed by magnetic resonance imaging.through study completion, an average of 1 year

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.

Secondary Outcome Measures
NameTimeMethod
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.through study completion, an average of 1 year

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

Trial Locations

Locations (1)

School of Life Science and Technology, University of Electronic Science and Technology

🇨🇳

Chengdu, Sichuan, China

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