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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active-Active | Active Comparator | 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 |
|
| Sham-Active | Sham Comparator | 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 |
|
| 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; 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Taoyuan | 33305 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36638598 | Derived | Ni HC, Chao YP, Tseng RY, Wu CT, Cocchi L, Chou TL, Chen RS, Gau SS, Yeh CH, Lin HY. Lack of effects of four-week theta burst stimulation on white matter macro/microstructure in children and adolescents with autism. Neuroimage Clin. 2023;37:103324. doi: 10.1016/j.nicl.2023.103324. Epub 2023 Jan 7. |
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Of the total 80 patients, 5 withdrew from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active-Active | 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 |
| FG001 | Sham-Active | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active-Active | 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 |
| BG001 | Sham-Active |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS) |
|
The adverse event would be assessed before and after intervention every session, up to 4 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active-Active | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain at application site | Nervous system disorders | Non-systematic Assessment | Phase 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hsing Chang Ni | Chang Gung Memorial Hospital | 886975365663 | alanni0918@yahoo.com.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2020 | Jun 22, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 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) |
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Full scale intelligence | Wechsler Adult Intelligence Scale IV can measure the general intelligence with the range from 40-160. The higher scores stand for better intelligence. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| Repetitive Behavior Scale-Revised | RBS-R is a questionnaire that focuses on repetitive behavior. The score ranges from 0-129. The lower scores stand for lower repetitive behavior. | Mean | Standard Deviation | units on a scale |
|
| Eye 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). | Mean | Standard Deviation | units on a scale |
|
| Frith-Happe Animation (Total) | 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 0-8). | Mean | Standard Deviation | units on a scale |
|
| Comorbidity with ADHD | Count of Participants | Participants |
|
| Medication (Methylphenidate) | Count of Participants | Participants |
|
| Medication (Atomoxetine) | Count of Participants | Participants |
|
| Medication (Antipsychotics) | Count of Participants | Participants |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS) |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS) |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS) |
|
|
|
| Secondary | Functional MRI (Biological Motion Task) | The MRI data have to be pre-processed before analysis. It may take few years. | Not Posted | baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline) | Participants |
| Secondary | Resting State fMRI | The MRI data have to be pre-processed before analysis. It may take few years. | Not Posted | baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline) | Participants |
| Secondary | Diffusion Tensor Imaging | The MRI data have to be pre-processed before analysis. It may take few years. | Not Posted | baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline) | Participants |
| 0 |
| 40 |
| 0 |
| 40 |
| 4 |
| 40 |
| EG001 | Sham-Active | 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 | 0 | 35 | 0 | 35 | 10 | 35 |
| Pain at application site | Nervous system disorders | Non-systematic Assessment | Phase 2 |
|
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| Post TBS |
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| One month follow up |
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| Post TBS |
|
| One month follow up |
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| Post TBS |
|
| One month follow up |
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