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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Device: repetitive Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rTMS Group<br>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. | Device: repetitive Transcranial Magnetic Stimulation<br>* A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Response Scale (SRS) | 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. | Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repetitive Stereotyped Behavior - Revised (RBS-R) | 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. | Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention | 
| ADHD Rating Scale | ADHD Rating Scale is the most widely used ADHD screening and treatment monitoring tools. | Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention | 
| Behavior Rating Inventory of Executive Function(BRIEF) | 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. | Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention | 
| Childhood Autism Rating Scale (CARS) | 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. | Before intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention | 
| Clinical Efficacy Rating Scale (CGI) | CGI is a scale used to assess the severity of the illness and the global improvement of the patient under intervention. | 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Repetitive Transcranial Magnetic Stimulation（rTMS）, Continuous theta Burst Stimulation （cTBS）