The Impacts of Theta-burst Stimulation on Children and Adolescents With Autism Spectrum Disorder

Study Overview
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Brief Summary
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The investigator would like to investigate the impact of theta-burst stimulation over posterior superior temporal sulcus in children and adolescents with autism spectrum disorder

Official Title
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The Impacts of Theta-burst Stimulation Over Posterior Superior Temporal Sulcus on Children and Adolescents With Autism Spectrum Disorder

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Device: intermittent theta burst stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: autism spectrum disorder, confirmed by ADOS Exclusion Criteria: current and past systemic disease current and past major psychiatric disorders including schizophrenia, bipolar affective disorder and major depressive disorder current and past brain injuries intelligence < 70 seizure history pregnant

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active-Active<br>Participants received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 8 weeks (2 days/week). *iTBS = intermittent theta burst stimulation | Device: intermittent theta burst stimulation<br>* stimulatory protocol<br>|
| Sham Comparator: Sham-Active<br>Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the posterior superior temporal sulcus for 4 weeks (2 days/week) and then received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 4 weeks (2 days/week). *iTBS = intermittent theta burst stimulation | Device: intermittent theta burst stimulation<br>* stimulatory protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Total Scores of Social Responsiveness Scale | Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness. | baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS) | 
| Changes of Total Scores of Repetitive Behavior Scale-Revised | RBS-R is a questionnaire that focuses on repetitive behavior. The score range from 0-129. The lower scores stand for lower repetitive behavior. | baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Accuracy of Frith-Happe Animation | A quick and objective test of Theory of Mind. 8 questions in total, the more correct questions stand for better Social Cognition (The score ranges from 0-48). | baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS) | 
| Changes in Accuracy of Eyes Task | An advanced test for Theory of Mind. 43 questions in total, the more correct questions stand for better social skills (The score ranges from 0-43). | baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS) | 
| Functional MRI (Biological Motion Task) | The MRI data have to be pre-processed before analysis. It may take few years. | baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline) | 
| Resting State fMRI | The MRI data have to be pre-processed before analysis. It may take few years. | baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline) | 
| Diffusion Tensor Imaging | The MRI data have to be pre-processed before analysis. It may take few years. | baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline) |