NCT05238298

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

This study is a 6-week open-label clinical trial involving 20 children aged 6-10 years with autism spectrum disorder. During the study, subjects received repeated transcranial magnetic stimulation（rTMS）intervention at the left primary motor cortex (M1) 5 times per day for 10 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.Our purpose 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.

Detailed description

Participants will receive continuous theta burst stimulation (cTBS) for a 10-day period (10 sessions). 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 four times, specifically，before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DEVICE	repetitive Transcranial Magnetic Stimulation	A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.

Timeline

• Start date: 2022-01-28
• Primary completion: 2022-03-29
• Completion: 2022-04-01
• First posted: 2022-02-14
• Last updated: 2022-05-05

Locations

1 site across 1 country: China