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| Name | Class |
|---|---|
| China Rehabilitation Research Center | OTHER_GOV |
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This study aims to evaluate the neuromodulation (i.e., iTBS) effectiveness for treating autism spectrum disorder (ASD) by targeting at the pBFS-guided executive function brain network or social brain network.
Autism spectrum disorder is characterized by executive function deficiency and social interaction difficulty. Using the developed technique, personalized brain functional sectors (pBFS), we could precisely identify individualized brain function networks based on the resting-state functional MRI scan. A tailored dorsal lateral prefrontal cortex (DLPFC) region situated within the executive function network and a tailored dorsal medial prefrontal cortex (DMPFC) region situated within the social network will be selected as intervention targets.
The participants will be equally randomized to the following three groups, active iTBS to the left DLPFC, active iTBS to the left DMPFC, and sham iTBS to either the left DLPFC or left DMPFC at a ratio of 2:2:1:1. Each participant will receive 1800 pulse active or sham iTBS (100% RMT) in each session, 3 sessions daily, 5 days per week for 8 weeks, as well as background behavioral training between iTBS sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLPFC group | Experimental | Active iTBS will be delivered to the left DLPFC. |
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| DMPFC group | Experimental | Active iTBS will be delivered to the left DMPFC. |
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| Sham to DLPFC group | Sham Comparator | Sham iTBS will be delivered to left DLPFC. |
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| Sham to DMPFC group | Sham Comparator | Sham iTBS will be delivered to left DMPFC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active iTBS | Device | Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| ADOS-2 SA change | The social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline | Pre-treatment (baseline), immediately post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| ADOS-2 total score change | The total score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline | Pre-treatment (baseline), immediately post-treatment |
| CBCL score change |
| Measure | Description | Time Frame |
|---|---|---|
| SRS-2 score change | Sore change of the Social Responsiveness Scale, 2nd edition (SRS-2) from baseline | Pre-treatment (baseline), immediately post-treatment |
| RBS-R score change | Score change of the Repetitive Behavior Scale-Revised (RBS-R) from baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Liu | Contact | 010-80726688 | a0000153@cpl.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hesheng Liu, Ph.D. | Changping Laboratory | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Rehabilitation Research Center | Recruiting | Beijing | China |
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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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| sham iTBS | Device | Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks. |
|
Score change of the child behavior checklist (CBCL) from baseline
| Pre-treatment (baseline), immediately post-treatment |
| Pre-treatment (baseline), immediately post-treatment |