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| Name | Class |
|---|---|
| China Rehabilitation Research Center | OTHER_GOV |
| Henan Provincial People's Hospital | OTHER |
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This study will evaluate the feasibility and preliminary efficacy of pBFS-guided TMS treatment at DMPFC in autism spectrum disorder comorbid with language delay.
Autism spectrum disorder is a neurodevelopmental disorder characterized by impaired social communication and repetitive behaviors, often co-occurring with language delay. Using the personalized Brain Functional Sectors (pBFS) technique, investigators could precisely identify individualized brain areas underlying language and social communication a based on the resting-state functional MRI data. The tailored TMS intervention target to language and default mode network which located in the left dorsal medial prefrontal cortex (DMPFC) will be selected for each participant.
The participants will receive active iTBS to the language network 5 days per week for 12 weeks. Functional MRI data will be collected pre-and post-treatment under sedation. Three behavioral evaluations will be taken pre-treatment, after 8-weeks treatment and after 12-weeks treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active iTBS group | Experimental | Active iTBS will be delivered to the tailored DMPFC target. |
|
| 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 |
|---|---|---|
| Language score change | The score change of vocabulary acquisition scales (VAS) from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) from baseline. Higher scores mean a better outcome. | Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment |
| ADOS-2 SA score change | The social affect dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Receptive vocabulary score change | The score change of receptive vocabulary (pointing) from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) from baseline. Higher scores mean a better outcome. | Pre-treatment (baseline), after 8 weeks treatment, 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), after 8 weeks treatment, immediately post-treatment |
| ADOS-2 RRB score change |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Rehabilitation Research Center | Beijing | China |
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| Expressive language score change |
The score change of picture naming (naming) from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) from baseline. Higher scores mean a better outcome. |
| Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment |
| SCQ S score change | The social dimension score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment |
| SCQ C score change | The communication dimension score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment |
The restricted and repetitive behavior score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome. |
| Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment |
| SCQ total score change | The total score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment |
| SCQ R score change | The RRB dimension score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment |
| CBCL score change | Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome. Higher scores mean a worse outcome. | Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment |