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Exploring the therapeutic efficacy of Theta Burst Stimulation (TBS) over the right inferior frontal gyrus (RIFG) in autism, including changes in core symptoms, adaptive functioning, neuropsychological performance, and neurophysiological signals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Participants received the intervention of iTBS (The total pulse of every session is 600 pulses) over right inferior frontal gyrus for 4 weeks (5 days/week). *iTBS = intermittent theta burst stimulation |
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| Sham | Sham Comparator | Participants received the sham intervention of iTBS (sham-coil) over right inferior frontal gyrus for 4 weeks (5 days/week). |
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| 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 (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) |
| 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 (8 weeks after baseline); Two months follow up (12 weeks after baseline) |
| 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 (8 weeks after baseline); Two months follow up (12 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsing-Chang Ni, Ph.D | Contact | 88633281200 | 2479 | alanni0918@yahoo.com.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Recruiting | Taoyuan | Taiwan |
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| 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 (8 weeks after baseline); Two months follow up (12 weeks after baseline) |
| Changes of total scores of Anxiety Scale for Autism | ASA is a parents' report questionnaire for severity of anxiety in children with ASD. The score ranges from 0-72. The lower scores stand for better emotional regulation. | baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) |
| 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 40-120. The higher scores stand for better adaptive behavior. | baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) |
| 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 (8 weeks after baseline); Two months follow up (12 weeks after baseline) |
| 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 (8 weeks after baseline); Two months follow up (12 weeks after baseline) |
| 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 (8 weeks after baseline); Two months follow up (12 weeks after baseline) |
| 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 20-110. The lower scores stand for better executive function. | baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) |
| 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 (8 weeks after baseline); Two months follow up (12 weeks after baseline) |
| baseline; post TBS (4 weeks after baseline) |
| DTI Mean-FA Tractometry - Left Arcuate Fasciculus (AF_left) | This outcome is the mean fractional anisotropy (FA) of the left arcuate fasciculus (AF_left) computed using DTI-based tractometry. FA is a unitless metric (range 0-1) that reflects the degree of diffusion anisotropy. A diffusion tensor was fitted to the diffusion MRI data to generate FA maps, and FA values were sampled within the AF_left tract mask/tract reconstruction and averaged to yield one mean FA value per participant per time point. | baseline; post TBS (4 weeks after baseline) |
| Electroencephalography | Resting state EEG (alpha power / frontal gamma power). | baseline; post TBS (4 weeks after baseline) |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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