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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
66
Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 12 weeks.
Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 12 weeks.
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.
Henan Provincial People's Hospital
Zhengzhou, Henan, China
RECRUITINGChina Rehabilitation Research Center
Beijing, China
RECRUITINGResponse 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.
Time frame: Pre-treatment (baseline), after 12-weeks treatment
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.
Time frame: Pre-treatment (baseline), after 8-weeks treatment
ADOS-2 SA score change
The ADOS-2 SA score changes from baseline. Higher scores mean a worse outcome.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
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SRS-2 score change
Score change of the Social Responsiveness Scale, 2nd edition (SRS-2) from baseline. Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment