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Efficacy and Mechanism of rTMS in Children With ASD: an Open-label Clinical Trial(Ⅱ)

Autism Spectrum Disorder Clinical Trial

Official title:
Efficacy and Mechanism of Repeated Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorder: an Open-label Clinical Trial(Ⅱ)

Clinical Trial Summary

This study is a open-label clinical trial involving over 30 children aged ≥4 years with autism spectrum disorder. During the study, subjects received repeated transcranial magnetic stimulation (rTMS) intervention at the left primary motor cortex (M1) 10 times per day for 5 days. From the beginning of intervention to the end of 4 weeks after the completion of intervention, the subjects's clinical symptomatology, cognitive psychology, neuroimaging, and adverse events will be followed up. Based on results from a recent unpublished pilot data, the investigators propose that cTBS treatment will induce a significant improvement in verbal/social communication performance in ASD children.

Clinical Trial Description

Participants will receive continuous theta burst stimulation (cTBS) for a 5 day period (5 sessions), 10 times a day, for about 3min each. If feasible for the participant, all stimulation sessions will be held at the same time of the day. During this study, participants' clinical symptomatology, cognitive psychology, neuroimaging, and adverse events will be followed up for three times, specifically before intervention, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.The purpose of this current study is to explore whether rTMS can improve the clinical symptoms of children with autism spectrum disorder in China, and to explore the neurophysiological mechanism of rTMS for autistic children. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05472870
Study type Interventional
Source Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Contact
Status Enrolling by invitation
Phase N/A
Start date July 12, 2022
Completion date December 2023
View Details
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