Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Language Deficit Comorbid in Autism Spectrum Disorder Child: 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
- 150
- 试验地点
- 1
- 主要终点
- CLAS-TP score change after treatment
研究概览
简要总结
The aim of this trial is to evaluate the efficacy and safety of precision neuromodulation in improving language ability in children with autism spectrum disorder (ASD) who also have language development delay. The neuromodulation will be delivered using the accelerated intermittent theta burst stimulation (aiTBS) protocol, targeting the language network in the left superior frontal gyrus (SFG), guided by personalized Brain Functional Sector (pBFS) technology.
详细描述
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder often accompanied by language delay. Emerging evidence indicates that Transcranial Magnetic Stimulation (TMS) has been effective in restoring language ability in post-stroke aphasia, but its efficacy in developmental language disorders remains unknown.
By leveraging the personalized Brain Functional Sector (pBFS) technique and task-free functional MRI scans, we can accurately locate the individual language function brain network. Considering the accessibility and comfort of neuromodulation, we will stimulate the language network node in the superior frontal gyrus (SFG) for 12 weeks.
In this study, participants meeting the inclusion and exclusion criteria will be randomly assigned to either the active or sham iTBS (intermittent theta burst stimulation) groups at a ratio of 2:1. The treatment protocol lasts for 12 weeks, with sessions held 5 days a week and 3 iTBS sessions over the SFG per day. The inter-session interval is set at 50 minutes, along with speech therapy. Clinical evaluations focusing on language and ASD symptoms will be conducted at baseline, after the 12-week treatment period, and at 24-week follow-up after the start of 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
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Professionally diagnosed with ASD per DSM - 5 criteria.
- •Aged 3 - 6.5 years, either gender.
- •ADOS-2 results meet ASD standard cut - off.
- •SCQ score: ≥15 (age ≥ 4 years) or ≥11 (age < 4 years).
- •Co-existing language disorder not explaining ASD symptoms. No organic speech organ lesions. CNBS-R2016 and CLAS-TP language-related equivalent age > 18 months; any CLAS-TP dimension score <
- •Mandarin is the daily communication language.
- •May have intellectual/global developmental delay not explaining ASD symptoms.
- •Guardians volunteer, can cooperate in treatment and sign informed consent.
排除标准
- •Identified genetic pathogenic factors; current/past comorbid severe disorders (ADHD, Tourette's, etc.).
- •Serious self-harm in the past year.
- •Severe sensory/motor disorders precluding cooperation.
- •History of epileptic seizures.
- •Serious organic diseases, especially brain related.
- •Contraindications for MRI/TMS (metal/implants).
- •Respiratory/circulatory diseases with sedation risk.
- •Illiterate guardians unable to handle informed consent/questionnaires.
- •Received neuromodulation in the past 3 months.
- •Currently in other clinical trials.
- •Deemed unfit by the researcher.
研究组 & 干预措施
active iTBS group
active iTBS over SFG
干预措施: active iTBS (Device)
active iTBS group
active iTBS over SFG
干预措施: speech therapy (Behavioral)
Sham group
sham iTBS over SFG
干预措施: Sham iTBS (Device)
Sham group
sham iTBS over SFG
干预措施: speech therapy (Behavioral)
结局指标
主要结局
CLAS-TP score change after treatment
时间窗: Pre-treatment (baseline), post-treatment (12-week)
The score changes of combined CLAS-TP (Child Language Assessment Scale - Test for Preschoolers) score at 12-week from baseline. Higher scores mean a better outcome.
次要结局
- CLAS-TP total score change from baseline to follow-up(Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week))
- WPPSI language score change from baseline to follow-up(Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week))
- ADOS-2 SA score change from baseline to follow-up(Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week))
- CLAS-TP subscale score change from baseline to follow-up(Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week))