Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Henan Provincial People's Hospital | OTHER |
| China Rehabilitation Research Center | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
This study will evaluate the efficacy and safety of pBFS-guided TMS treatment for the core symptom in autism spectrum disorder children, adolescents and young adults.
Autism spectrum disorder is a neurodevelopmental disorder characterized by impaired social communication and repetitive behaviors. Broad cognitive control function deficit in ASD suggested cognitive control function as a potential phenotype and treatment target. Using the personalized Brain Functional Sectors (pBFS) technique, investigators could precisely identify individualized brain areas underlying cognitive control function based on the task free functional MRI data. The tailored TMS intervention target to cognitive control function network which located in the left dorsal lateral prefrontal cortex (DLPFC) will be selected for each participant by a blinded researcher.
The participants will be equally randomized to the active iTBS to the cognitive control function network, and sham iTBS at a ratio of 2:1. Each participant will receive 5 days of treatment per week for 12 weeks. Functional MRI data under sedation will be collected pre-and post-treatment. Three behavioral evaluations will be taken pre-treatment, after 8-weeks treatment and after 12-weeks treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLPFC group | Experimental | Active iTBS will be delivered to the cognitive control network at left DLPFC. |
|
| Sham group | Sham Comparator | Sham iTBS will be delivered to the cognitive control network at left DLPFC. |
|
| 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 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate after 12 weeks treatment | Treatment response is defined as improvement, i.e., scores decreased, in both the social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. For ADOS-2 SA, higher scores means more severe symptom. | Pre-treatment (baseline), after 12-weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate after 8 weeks treatment | Treatment response is defined as improvement, i.e., scores decreased, in the social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. For ADOS-2 SA, higher scores means more severe symptom. | Pre-treatment (baseline), after 8-weeks treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41986743 | Derived | Liu Q, Zhang J, Duan X, Zhang P, Yang Y, Yao G, Jiaerheng B, Shou XJ, He Y, Han K, Jia M, Wang L, Gong W, Xie W, Sun K, Wang D, Wu XD, Cao H, Zhang H, Liu H. Accelerated intermittent theta burst stimulation targeting personalized fronto-parietal control network improves core symptoms of autism spectrum disorder: a double-blind, randomized controlled trial. Mol Psychiatry. 2026 Apr 15. doi: 10.1038/s41380-026-03596-2. Online ahead of print. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 12 weeks. |
|
| traditional 1on1 course | Behavioral | Between every two iTBS sessions, the participant will receive a personalized 30-minutes one-on-one behavioral course, 2 courses per day, 5 days per week for 12 weeks. |
|
| ADOS-2 SA score change |
The ADOS-2 SA score changes from baseline. Higher scores mean a worse outcome. |
| Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment |
| SCQ score change | SCQ score change from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment |
| ADOS-2 total score change | The ADOS-2 total score change from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment |
| CBCL score change | Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment |
| SRS-2 score change | Score change of the Social Responsiveness Scale, 2nd edition (SRS-2) from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment |
| China Rehabilitation Research Center | Recruiting | Beijing | China |
|