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Therapeutic Intervention Effects of rTMS on Children With Autism Spectrum Disorder

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05140356
Enrollment
60
Registered
2021-12-01
Start date
2019-05-01
Completion date
2024-12-31
Last updated
2021-12-01

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, transcranial magnetic stimulation, Magnetic Resonance Imaging, eye movement, gut microbiome

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.

Interventions

DEVICEApplied high amplitude repeated transcranial magnetic stimulation

Each mode required 20 stimuli(100%RMT) for 20 minutes each time, 5 times a week

DEVICEApplied low amplitude repeated transcranial magnetic stimulation

Each mode required 20 stimuli(15%RMT) for 20 minutes each time, 5 times a week

Sponsors

University of Electronic Science and Technology of China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
No

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
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 yearLongitudinal 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

MeasureTime frameDescription
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 yearLongitudinal 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

Countries

China

Contacts

Primary ContactHuafu Chen
chenhf@uestc.edu.cn
Backup ContactHuafu Chen, Study Principal Investigator
chenhf@uestc.edu.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026