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

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Device: repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT05238298
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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.

Study Timeline

• Study Start: 2022-01-28
• Study First Submitted: 2022-01-29
• Study First Submitted QC: 2022-02-11
• Study First Posted: 2022-02-14
• Primary Completion: 2022-03-29
• Study Completion: 2022-04-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Children aged 6-10 years.
• Meeting the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Edition 5 (DSM-5) .
• Confirmed by the ADOS and/or ADI-R diagnostic tool.
• IQ ≥70.
• Informed consent.

Exclusion Criteria

• Patients with metal implants .
• Patients with neurological diseases such as epilepsy .
• Patients requiring surgical treatment due to structural abnormalities indicated by brain MRI .
• Genetic or chromosomal abnormalities .
• Suffering from mental disorders (such as mood disorders, etc.)
• Suffering from serious heart disease .
• Hearing-impaired .
• Intracranial hypertension .
• Participating in other clinical trials.
• Participants who received other interventions within 4 weeks prior to enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rTMS Group	repetitive Transcranial Magnetic Stimulation	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.

Primary Outcome Measures

Name	Time	Method
Social Response Scale (SRS)	Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention	SRS is a questionnaire used to assess the presence and severity of social impairment, with high scores indicating severe symptoms. Change of the SRS from baseline to 3 month after treatment to evaluate the effect of computer social interaction treatment on ASD children.

Secondary Outcome Measures

Name	Time	Method
ADHD Rating Scale	Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention	ADHD Rating Scale is the most widely used ADHD screening and treatment monitoring tools.
Clinical Efficacy Rating Scale (CGI)	5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention	CGI is a scale used to assess the severity of the illness and the global improvement of the patient under intervention.
Behavior Rating Inventory of Executive Function(BRIEF)	Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention	Specifically the investigators will evaluate the changes in executive function (EF) scores before and after cTBS treatment. The higer scores indicate more impairment in executive function.
Childhood Autism Rating Scale (CARS)	Before intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention	CARS is a behaviour-rating scale used to assess the presence and severity of the symptoms of autism spectrum disorder(ASD), with scores ranging from 15 to 60 and high scores indicating severe symptoms. Change of the CARS from baseline to 3 months after treatment to evaluate the effect of tablet computer social interaction treatment on ASD children.
Repetitive Stereotyped Behavior - Revised (RBS-R)	Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention	The Repetitive Behaviors Scale - Revised (RBS-R) is a 44-item self-report questionnaire that is used to measure the breadth of repetitive behavior in children, adolescents, and adults with Autism Spectrum disorders. The RBS-R provides a quantitative, continuous measure of the full spectrum of repetitive behaviors. The RBS-R consists of six subscales including: Stereotyped Behavior, Self-injurious Behavior, Compulsive Behavior, Routine Behavior, Sameness Behavior, and Restricted Behavior, that have no overlap of item content.

Trial Locations

Locations (1)

ShanghaiXinhua; 🇨🇳 Shanghai, Shanghai, China