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| Name | Class |
|---|---|
| Henan Provincial People's Hospital | OTHER |
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This randomized controlled trial aims to evaluate the efficacy and safeness of the pBFS-guided rTMS intervention for core symptom relief in pre-school children with autism spectrum disorder (ASD).
Autism spectrum disorder is a neurodevelopmental disorder, begins early in life. Using the personalized brain functional sectors (pBFS) technology, investigators could precisely identify individualized brain function networks based on the functional MRI scan. For each participant, two personalised TMS intervention targets will be chosen by blinded researcher. One executive function network target is located in the dorsal lateral prefrontal cortex (DLPFC) , and the other social function network target is located in the dorsal medial prefrontal cortex (DMPFC).
The participants will be equally randomized to the following four groups, active iTBS to the left DMPFC or the left DLPFC, and sham iTBS to either the left DMPFC or left DLPFC at a ratio of 2:2:1:1. Later analyses will combine the two sham groups as one control group. 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. Pre-and post-treatment functional MRI data will be collected under sedation.
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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 the left DLPFC. |
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| Sham to DMPFC group | Sham Comparator | Sham iTBS will be delivered to the 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. Higher scores mean a worse outcome. | 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. Higher scores mean a worse outcome. | Pre-treatment (baseline), immediately post-treatment |
| CBCL score change |
| Measure | Description | Time Frame |
|---|---|---|
| SCQ score change | Score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), immediately post-treatment |
| SRS-2 score change |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Liu, Ph.D. | Contact | 010-80726688 | a0000153@cpl.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hesheng Liu, Ph.D. | Changping Laboratory | Study Chair |
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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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| 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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| 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. |
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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. |
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Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome.
| Pre-treatment (baseline), immediately post-treatment |
Score change of the Social Responsiveness Scale, 2nd edition (SRS-2) from baseline. Higher scores mean a worse outcome.
| Pre-treatment (baseline), immediately post-treatment |
| RBS-R score change | Score change of the Repetitive Behavior Scale-Revised (RBS-R) from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), immediately post-treatment |