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Therapeutic Intervention Effects of rTMS on Children With Autism Spectrum Disorder

U

University of Electronic Science and Technology of China

Status

Enrolling

Conditions

Autism

Treatments

Device: Applied high amplitude repeated transcranial magnetic stimulation
Device: Applied low amplitude repeated transcranial magnetic stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05140356
UESTC-chenhuafulab-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

2 to 8 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

60 participants in 3 patient groups

High amplitude repeated transcranial magnetic stimulation
Experimental group
Description:
Applied high amplitude repeated transcranial magnetic stimulation
Treatment:
Device: Applied high amplitude repeated transcranial magnetic stimulation
Low amplitude repeated transcranial magnetic stimulation
Experimental group
Description:
Applied low amplitude repeated transcranial magnetic stimulation
Treatment:
Device: Applied low amplitude repeated transcranial magnetic stimulation
healthy control group
No Intervention group
Description:
No intervention

Trial contacts and locations

1

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Central trial contact

Huafu Chen; Huafu Chen, Study Principal Investigator

Data sourced from clinicaltrials.gov

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