Personalized Brain Functional Sectors (pBFS) Guided Precision Neuromodulation Treatment for Autism Spectrum Disorder (ASD): a Single-center, Sham-controlled, Double-blinded, Randomized Clinical Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ADOS-2 SA change
研究概览
简要总结
This study aims to evaluate the neuromodulation (i.e., iTBS) effectiveness for treating autism spectrum disorder (ASD) by targeting at the pBFS-guided executive function brain network or social brain network.
详细描述
Autism spectrum disorder is characterized by executive function deficiency and social interaction difficulty. Using the developed technique, personalized brain functional sectors (pBFS), we could precisely identify individualized brain function networks based on the resting-state functional MRI scan. A tailored dorsal lateral prefrontal cortex (DLPFC) region situated within the executive function network and a tailored dorsal medial prefrontal cortex (DMPFC) region situated within the social network will be selected as intervention targets.
The participants will be equally randomized to the following three groups, active iTBS to the left DLPFC, active iTBS to the left DMPFC, and sham iTBS to either the left DLPFC or left DMPFC at a ratio of 2:2:1:1. Each participant will receive 1800 pulse active or sham iTBS (100% RMT) in each session, 3 sessions daily, 5 days per week for 8 weeks, as well as background behavioral training between iTBS sessions.
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
- •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 parents or other legal guardians give informed consent
排除标准
- •Current or history of psychotic disorders, such as schizophrenia, bipolar disorder
- •Severe self-injury or suicidal behavior presented in the last 1 year
- •Severe visual, auditory, or motor disability that interferes with any study procedure
- •Current, history or family history of epilepsy
- •Known severe physical diseases, such as congenital heart defects, 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
ADOS-2 SA change
时间窗: Pre-treatment (baseline), immediately post-treatment
The social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline
次要结局
- ADOS-2 total score change(Pre-treatment (baseline), immediately post-treatment)
- CBCL score change(Pre-treatment (baseline), immediately post-treatment)