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| Name | Class |
|---|---|
| Peking University Sixth Hospital | OTHER |
| Shanghai Sunshine Rehabilitation Center | OTHER |
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The aim of this trial is to evaluate the efficacy and safety of precision neuromodulation in improving language ability in children with autism spectrum disorder (ASD) who also have language development delay. The neuromodulation will be delivered using the accelerated intermittent theta burst stimulation (aiTBS) protocol, targeting the language network in the left superior frontal gyrus (SFG), guided by personalized Brain Functional Sector (pBFS) technology.
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder often accompanied by language delay. Emerging evidence indicates that Transcranial Magnetic Stimulation (TMS) has been effective in restoring language ability in post-stroke aphasia, but its efficacy in developmental language disorders remains unknown.
By leveraging the personalized Brain Functional Sector (pBFS) technique and task-free functional MRI scans, we can accurately locate the individual language function brain network. Considering the accessibility and comfort of neuromodulation, we will stimulate the language network node in the superior frontal gyrus (SFG) for 12 weeks.
In this study, participants meeting the inclusion and exclusion criteria will be randomly assigned to either the active or sham iTBS (intermittent theta burst stimulation) groups at a ratio of 2:1. The treatment protocol lasts for 12 weeks, with sessions held 5 days a week and 3 iTBS sessions over the SFG per day. The inter-session interval is set at 50 minutes, along with speech therapy. Clinical evaluations focusing on language and ASD symptoms will be conducted at baseline, after the 12-week treatment period, and at 24-week follow-up after the start of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active iTBS group | Experimental | active iTBS over SFG |
|
| Sham group | Sham Comparator | sham iTBS over SFG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active iTBS | Device | Participants will undergo three iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Individualized targets will be generated using the pBFS technique. |
| Measure | Description | Time Frame |
|---|---|---|
| CLAS-TP score change after treatment | The score changes of combined CLAS-TP (Child Language Assessment Scale - Test for Preschoolers) score at 12-week from baseline. Higher scores mean a better outcome. | Pre-treatment (baseline), post-treatment (12-week) |
| Measure | Description | Time Frame |
|---|---|---|
| CLAS-TP total score change from baseline to follow-up | Higher scores mean a better outcome. | Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week) |
| CLAS-TP subscale score change from baseline to follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| SCQ score change from baseline to follow-up | Higher scores mean a worse outcome. | Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week) |
| ATEC score change from baseline to follow-up | Higher scores mean a worse outcome. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinyu Duan | Contact | 13691009590 | xinyu.duan@neuralgalaxy.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Sixth Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D007805 | Language Development Disorders |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D007806 | Language Disorders |
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| ID | Term |
|---|---|
| D013070 | Speech Therapy |
| ID | Term |
|---|---|
| D012049 | Rehabilitation of Speech and Language Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Sham iTBS | Device | Participants will undergo three sham iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Sham stimulation will be delivered through a sham coil with the identical appearance as real coil. Individualized targets will be generated using the pBFS technique. |
|
| speech therapy | Behavioral | Speech therapy will be delivered between iTBS/sham sessions. Two 30-minutes trainings every day. |
|
For the story comprehension subscale, only participants who had non-zero point were included.
Higher scores mean a better outcome.
| Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week) |
| WPPSI language score change from baseline to follow-up | Higher scores mean a better outcome. | Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week) |
| ADOS-2 SA score change from baseline to follow-up | Higher scores mean a worse outcome. | Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week) |
| Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week) |
| CBCL score change from baseline to follow-up | Higher scores mean a worse outcome. | Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week) |
| QoL score change from baseline to follow-up | Higher scores mean a better outcome. | Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week) |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005791 | Patient Care |
| D013812 | Therapeutics |