Repetitive Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Low-Functioning Autism Spectrum Disorder: a Multi-center, Randomized, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 215
- 试验地点
- 6
- 主要终点
- ADOS-2 SA CSS score change after treatment
研究概览
简要总结
The aim of this trial is to assess the efficacy and safety of precision neuromodulation for alleviating core symptoms in patients with autism spectrum disorder (ASD) who also have intellectual or developmental delay. The neuromodulation will be administered using intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC), guided by personalized Brain Functional Sector (pBFS) technology.
详细描述
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by impaired social communication and repetitive behaviors. Unfortunately, evidence-based treatments have not proven effective for older individuals with low-functioning ASD, despite their significant need for intensive support. However, emerging evidence suggests that Transcranial Magnetic Stimulation (TMS) has been successful in treating various psychiatric and neurological disorders.
Given the broad cognitive control dysfunction observed in ASD, targeting cognitive control function may offer a promising treatment approach. Leveraging the personalized Brain Functional Sector (pBFS) technique and task-free functional MRI scans, we can precisely locate the cognitive control function region within the left DLPFC, and follow-up at 24-week after initiation of treatment.
In this study, participants who meet the inclusion and exclusion criteria will be randomly assigned to either active or sham iTBS (intermittent theta burst stimulation) groups at a ratio of 2:1. The treatment protocol consists of a 12-week duration, with sessions conducted 5 days per week and 3 sessions iTBS over DLPFC per day. The inter-session interval is set at 30 minutes. Clinical evaluations focusing on ASD core symptoms and related behavioral profiles will be conducted at baseline and after the 12-week treatment period.
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
- •Comorbid with intelligent disorder, IQ/DQ < 70
- •Primary environmental language is Chinese
- •Participant's parents or other legal guardians give informed consent
排除标准
- •Genetic Disorders, such as (e.g., Down syndrome, Fragile X syndrome, Rett syndorme), Current or history of severe ADHD, tourette syndrome, psychotic disorders (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)
- •Severe self-injury or suicidal behavior exhibited within the past year
- •Significant visual, auditory, deafness or motor disability that prevent them from following study procedures
- •Current or history diagnosis of epilepsy
- •Known severe physical diseases, particularly those affecting the brain
- •Metal implantation contradicted by MRI or TMS, such as artificial cardiac pacemakers, stents, cochlear implants
- •Respiratory or circulatory conditions increasing sedation risk, such as Apnea syndrome, severe snoring, or other relevant diseases
- •All legal guardians are illiterate, unable to read informed documents or complete questionnaires independently
- •Received transcranial magnetic stimulation (TMS), transcranial current stimulation (tCS), focused ultrasound (FUS), or other neuromodulation treatment in the last 3 months
- •Current participation in other clinical trials
结局指标
主要结局
ADOS-2 SA CSS score change after treatment
时间窗: Pre-treatment (baseline), post-treatment (12-week)
The score changes of ADOS-2 SA CSS (Autism Diagnostic Observation Scale, 2nd edition, social affect domain, calibrated severity score) at 12-week from baseline. Higher scores mean a worse outcome.
次要结局
- ADOS-2 SA CSS score change from baseline to follow-up(Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week))
- Response rate in social ability after 12-week iTBS treatment(Pre-treatment (baseline), post-treatment (12-week))
- Response rate in social ability at 24-week follow-up(Pre-treatment (baseline), follow-up (24-week))
- ADOS-2 total CSS change with treatment(Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week))
- SCQ score change with treatment(Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week))
- CBCL score change with treatment(Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week))
- QoL score change with treatment(Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week))
- AIM score change with treatment(Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week))