Personalized Brain Functional Sectors (pBFS) Guided Transcranial Magnetic Stimulation (TMS) Treatment for Autism Spectrum Disorder (ASD): a Sham-controlled, Double-blinded, Randomized Clinical Trial Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Response rate after 12 weeks treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nearest age 6-30 years old
- •Have the diagnosis of autism spectrum disorder
- •ADOS-2 score is higher than the ASD cut-offs
- •Capacity to follow the study procedures, including fMRI scan under sedation, assessment, and rehabilitation training
- •Participant's parent or other legal guardian give informed consent
排除标准
- •Current or history of psychotic disorders, such as schizophrenia, schizoaffective disorder, bipolar disorder
- •Severe self-injury or suicidal behavior presented in the last one year
- •Severe visual, auditory, or motor disability that interferes with any study procedure
- •Current or history of seizure
- •Known severe physical diseases, such as congenital heart defect, traumatic brain injury
- •Metal implantations, which are contradicted by MRI or TMS, such as artificial cardiac pacemakers, stents, cochlear implants
- •Received TMS, tCS, FUS, or other neuromodulation treatment in the last 3 months
- •Currently participating in other clinical trials
结局指标
主要结局
Response rate after 12 weeks treatment
时间窗: Pre-treatment (baseline), 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.
次要结局
- SCQ score change(Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment)
- Response rate after 8 weeks treatment(Pre-treatment (baseline), after 8-weeks treatment)
- SRS-2 score change(Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment)
- ADOS-2 total score change(Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment)
- ADOS-2 SA score change(Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment)
- CBCL score change(Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment)