Personalized Brain Functional Sectors (pBFS) Guided Noninvasive Neuromodulation Treatment for Pre-school Children With Autism Spectrum Disorder (ASD): a Single-center, Double-blinded, Sham-Controlled, Randomized Clinical Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- ADOS-2 SA change
研究概览
简要总结
This randomized controlled trial aims to evaluate the efficacy and safeness of the pBFS-guided rTMS intervention for core symptom relief in pre-school children with autism spectrum disorder (ASD).
详细描述
Autism spectrum disorder is a neurodevelopmental disorder, begins early in life. Using the personalized brain functional sectors (pBFS) technology, investigators could precisely identify individualized brain function networks based on the functional MRI scan. For each participant, two personalised TMS intervention targets will be chosen by blinded researcher. One executive function network target is located in the dorsal lateral prefrontal cortex (DLPFC) , and the other social function network target is located in the dorsal medial prefrontal cortex (DMPFC).
The participants will be equally randomized to the following four groups, active iTBS to the left DMPFC or the left DLPFC, and sham iTBS to either the left DMPFC or left DLPFC at a ratio of 2:2:1:1. Later analyses will combine the two sham groups as one control group. 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. Pre-and post-treatment functional MRI data will be collected under sedation.
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
- 30 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2.5-6 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, schizoaffective disorder, 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 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
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. Higher scores mean a worse outcome.
次要结局
- ADOS-2 total score change(Pre-treatment (baseline), immediately post-treatment)
- CBCL score change(Pre-treatment (baseline), immediately post-treatment)