The Therapeutic Effect of TBS Stimulation Over Left Dorsolateral Prefrontal Cortex on Emotion Regulation in Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes of total scores of Emotional Dysregulation Inventory
研究概览
简要总结
The investigator would like to investigate the impact of intermittent theta burst stimulation over left dorsolateral prefrontal cortex on emotion regulation in autism spectrum disorder
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •autism spectrum disorder, confirmed by ADOS
排除标准
- •Previous or current severe neurological disorder such as epilepsy, visual or hearing impairment
- •Previous or current severe systemic disease such as cardiovascular disease, diabetes or infection
- •Previous or current severe brain injury
- •Implementation of metal materials such as pacemaker or medication pump
- •Previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder or substance abuse
- •Pregnancy
- •Individuals with a significant brain abnormality such as intracranial space occupied lesions
- •Individuals with a family history of epilepsy
- •Previous febrile seizures
- •Current taking antiepileptic drugs
- •Concurrent use of medications which increased the risk of seizure attack
- •Individuals suffering from sleep deprivation during rTMS procedures
- •Skin trauma on application site
- •Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to participate in the study
- •Participate another clinical trial within one month
结局指标
主要结局
Changes of total scores of Emotional Dysregulation Inventory
时间窗: baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS)
Emotional Dysregulation Inventory is a parents' report questionnaire for emotional dysregulation. The score ranges from 0-120. The lower scores stand for better emotional regulation.
Changes of total scores of Aberrant Behavior Checklist
时间窗: baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS)
ABC is a parents' report questionnaire for aberrant behavior. The lower scores stand for less aberrant behavior.
Changes of total scores of Child Behavior Checklist
时间窗: baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS)
CBCL is a parents' report questionnaire for behavioral and emotional problems. The lower scores stand for better behavioral and emotional regulation.
次要结局
- Changes in accuracy of Eyes task(baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS))
- Changes in accuracy of Wisconsin Card Sorting Test(baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS))
- Raven's Progressive Matrices(baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS))
- Changes of total scores of Adaptive Behavior Assessment System(baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS))
- Diffusion Tensor Imaging (DTI) - FA(baseline; post TBS (4 weeks after baseline))
- Electroencephalography(baseline; post TBS (4 weeks after baseline))
- Changes of total scores of Social Responsiveness Scale(baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS))
- Changes of total scores of Repetitive Behavior Scale-Revised(baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS))
- Changes in accuracy of Frith-Happe animation(baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS))
- MRI T1(baseline; post TBS (4 weeks after baseline))
- Changes of total scores of Behavior Rating Inventory of Executive Function(baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS))
- functional MRI (resting-state/biological motion task) - BOLD signal(baseline; post TBS (4 weeks after baseline))