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The investigator would like to investigate the impact of theta burst stimulation over right inferior frontal gyrus in autism spectrum disorder
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Participants received the real intervention of TBS (iTBS 600) over the right inferior frontal gyrus for 8 weeks (2 days/week). *iTBS = intermittent theta burst stimulation |
|
| Sham | Sham Comparator | Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the right inferior frontal gyrus for 8 weeks (2 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 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 (8 weeks after baseline); One month follow up (4 weeks after post TBS) |
| 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 (8 weeks after baseline); One month follow up (4 weeks after post TBS) |
| 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 (8 weeks after baseline); One month follow up (4 weeks after post TBS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsing-Chang Ni | 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39238103 | Derived | Ni HC, Chen YL, Hsieh MY, Wu CT, Chen RS, Juan CH, Li CT, Gau SS, Lin HY. Improving social cognition following theta burst stimulation over the right inferior frontal gyrus in autism spectrum: an 8-week double-blind sham-controlled trial. Psychol Med. 2024 Sep;54(12):3261-3272. doi: 10.1017/S0033291724001387. Epub 2024 Sep 6. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 3, 2024 | |
| Reset | Jun 14, 2024 | |
| Release | Jun 28, 2024 | |
| Reset | Oct 2, 2024 | |
| Release | May 14, 2025 | |
| Reset | May 30, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 3, 2024 | Jun 14, 2024 | |||
| Jun 28, 2024 |
| 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 Adaptive Behavior Assessment System |
Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior. The scores ranges from 9-171. The higher scores stand for better adaptive behavior. |
| baseline; post TBS (8 weeks after baseline); One month follow up (4 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 (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. | baseline; post TBS (8 weeks after baseline); One month follow up (4 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 (8 weeks after baseline); One month follow up (4 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 75-225. The lower scores stand for better executive function. | baseline; post TBS (8 weeks after baseline); One month follow up (4 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 (8 weeks after baseline); One month follow up (4 weeks after post TBS) |
| Autism Diagnostic Observation Schedule - Generic | The Autism Diagnostic Observation Schedule is a semi-structured assessment of communication, social interaction, and play (or imaginative use of materials) for individuals suspected of having autism spectrum disorders. The social affect domain includes the social and communication items ranging from 0 to 20. The higher scores stand for more clinical severity of autism spectrum disorder. | baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS) |
| MRI T1 | Brain structural volumes (cm²) | baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS) |
| 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 (8 weeks after baseline); One month follow up (4 weeks after post TBS) |
| 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 (8 weeks after baseline); One month follow up (4 weeks after post TBS) |
| Electroencephalography | Resting state EEG (alpha power / frontal gamma power) | baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS) |
| Oct 2, 2024 |
| May 14, 2025 | May 30, 2025 |