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The investigator would like to investigate the impact of intermittent theta burst stimulation over left dorsolateral prefrontal cortex on emotion regulation in autism spectrum disorder
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Participants received the real intervention of TBS (iTBS 600) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week). *iTBS = intermittent theta burst stimulation |
|
| Sham | Sham Comparator | Participants received the sham intervention of TBS (sham-coil) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intermittent theta burst stimulation | Device | stimulatory protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of total scores of Emotional Dysregulation Inventory | Emotional Dysregulation Inventory is a parents' report questionnaire for emotional dysregulation. The score ranges from 0-120. The lower scores stand for better emotional regulation. | baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS) |
| Changes of total scores of Aberrant Behavior Checklist | ABC is a parents' report questionnaire for aberrant behavior. The lower scores stand for less aberrant behavior. | baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS) |
| Changes of total scores of Child Behavior Checklist | CBCL is a parents' report questionnaire for behavioral and emotional problems. The lower scores stand for better behavioral and emotional regulation. | baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS) |
| 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; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsing-Chang Ni, Dr. | Contact | 88633281200 | 3815 | alanni0918@yahoo.com.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Recruiting | Taoyuan | 33305 | Taiwan |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 14, 2025 | |
| Reset | May 30, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 14, 2025 | May 30, 2025 | |||
| Jul 2, 2026 |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Changes of total scores of Repetitive Behavior Scale-Revised | Repetitive Behavior Scale-Revised is a questionnaire that focuses on repetitive behavior. The score ranges from 0-129. The lower scores stand for lower repetitive behavior. | baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS) |
| Changes of total scores of Adaptive Behavior Assessment System | Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior. The score ranges from 9-171. The higher scores stand for better adaptive behavior. | baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS) |
| 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. | baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 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. | baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS) |
| Changes in accuracy of Wisconsin Card Sorting Test | An advanced test for cognitive flexibility. 128 questions in total, the more correct questions stand for better cognitive flexibility. | baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS) |
| Changes of total scores of Behavior Rating Inventory of Executive Function | Behavior Rating Inventory of Executive Function is a parents' report questionnaire for executive function. The score ranges from 86-258. The lower scores stand for better executive function. | baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS) |
| Raven's Progressive Matrices | An advanced test for for executive function. 60 questions in total, the more correct questions stand for better executive function. | baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS) |
| MRI T1 | Brain structural volumes (cm²) | baseline; post TBS (4 weeks after baseline) |
| functional MRI (resting-state/biological motion task) - BOLD signal | Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity. | baseline; post TBS (4 weeks after baseline) |
| Diffusion Tensor Imaging (DTI) - FA | Fractional anisotropy (FA) is a measurement used in DTI, which reflects the movement of water molecules. FA ranges from 0 to 1, the higher FA value may represent more intact axons. | baseline; post TBS (4 weeks after baseline) |
| Electroencephalography | Resting state EEG (alpha power / frontal gamma power) | baseline; post TBS (4 weeks after baseline) |