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| Name | Class |
|---|---|
| Xi'an TCM Hospital of Encephalopathy | UNKNOWN |
| Linyi Hedong Rehabilitation Hospital | UNKNOWN |
| Jining Medical University | OTHER |
| Fujian Maternity and Child Health Hospital |
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The aim of this trial is to assess the efficacy and safety of precision neuromodulation for alleviating core symptoms in patients with autism spectrum disorder (ASD) who also have intellectual or developmental delay. The neuromodulation will be administered using intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC), guided by personalized Brain Functional Sector (pBFS) technology.
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by impaired social communication and repetitive behaviors. Unfortunately, evidence-based treatments have not proven effective for older individuals with low-functioning ASD, despite their significant need for intensive support. However, emerging evidence suggests that Transcranial Magnetic Stimulation (TMS) has been successful in treating various psychiatric and neurological disorders.
Given the broad cognitive control dysfunction observed in ASD, targeting cognitive control function may offer a promising treatment approach. Leveraging the personalized Brain Functional Sector (pBFS) technique and task-free functional MRI scans, we can precisely locate the cognitive control function region within the left DLPFC, and follow-up at 24-week after initiation of treatment.
In this study, participants who meet the inclusion and exclusion criteria will be randomly assigned to either active or sham iTBS (intermittent theta burst stimulation) groups at a ratio of 2:1. The treatment protocol consists of a 12-week duration, with sessions conducted 5 days per week and 3 sessions iTBS over DLPFC per day. The inter-session interval is set at 30 minutes. Clinical evaluations focusing on ASD core symptoms and related behavioral profiles will be conducted at baseline and after the 12-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active iTBS group | Experimental | active iTBS over DLPFC |
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| Sham group | Sham Comparator | sham iTBS over DLPFC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active iTBS treatment | 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 |
|---|---|---|
| ADOS-2 SA CSS score change after treatment | The score changes of ADOS-2 SA CSS (Autism Diagnostic Observation Scale, 2nd edition, social affect domain, calibrated severity score) at 12-week from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), post-treatment (12-week) |
| Measure | Description | Time Frame |
|---|---|---|
| ADOS-2 SA CSS score change from baseline to follow-up | The score changes of ADOS-2 SA CSS from baseline, to 12-week posttreatment and, to 24-week follow-up. Higher scores mean a worse outcome. | Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week) |
| Response rate in social ability after 12-week iTBS treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Liu, Ph.D. | Contact | 010-80726688 | liuqi@cpl.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hesheng Liu, Ph.D. | Changping Laboratory | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Children's Hospital | Recruiting | Fuzhou | Fujian | China | ||
| Fujian Maternity and Child Health Hospital |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D003147 | Communication Disorders |
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| OTHER |
| Hebei Provincial Mental Health Center | UNKNOWN |
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| sham iTBS treatment | Device | Participants will undergo three 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. |
|
Treatment response is defined as improvement, i.e., at least 1-point decreased, in the ADOS-2 SA For ADOS-2 SA, higher scores means more severe symptom. |
| Pre-treatment (baseline), post-treatment (12-week) |
| Response rate in social ability at 24-week follow-up | Treatment response is defined as improvement, i.e., at least 1-point decreased, in the ADOS-2 SA For ADOS-2 SA, higher scores means more severe symptom. | Pre-treatment (baseline), follow-up (24-week) |
| ADOS-2 total CSS change with treatment | The ADOS-2 total CSS score change from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week) |
| SCQ score change with treatment | The SCQ (Social Communication Questionnaire) score change from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week) |
| CBCL score change with treatment | The CBCL (Child Behavior Checklist) score change from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week) |
| QoL score change with treatment | The QoL (quality of life) score change from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week) |
| AIM score change with treatment | The AIM (Autism Impact Measure) score change from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week) |
| Recruiting |
| Fuzhou |
| Fujian |
| China |
| Hebei Provincial Mental Health Center | Recruiting | Baoding | Hebei | China |
| Xi'an TCM Hospital of Encephalopathy | Recruiting | Xi'an | Shaanxi | China |
|
| Jining Medical University | Recruiting | Jining | Shandong | China |
| Linyi Hedong Rehabilitation Hospital | Recruiting | Linyi | Shandong | China |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |