JPRN-jRCTs052180067已完成未知
Efficacy of repetitive transcranial magnetic stimulation for the communication and motor ability in children
Taniike Masako0 个研究点目标入组 3 人开始时间: 2019年2月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 3
研究概览
简要总结
This study was conducted on patients with autism spectrum disorder (ASD) using repetitive transcranial magnetic stimulation (rTMS). Its efficacy and safety were evaluated in a single-blind before/after comparison using sham stimulation. The fine motor function and gross motor performance with coordinated movements showed mild improvement only when the right primary motor and right dorsal premotor were stimulated. No apparent adverse events were observed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 10age old 至 <= 15age old（—）
- 性别
- Male
入选标准
- •1. Boys who were diagnosed as autism spectrum disorder in the clinic of developmental disorders in Osaka University Hospital. The diagnosis was made by specialists in child neurology or psychiatry according to the DSM-V (The Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders), ADI-R (Autism Diagnostic Interview, Revised) which is a specific interview form to the parent with ASD, or AODS (Autism Diagnostic Observation Schedule) which is a specific observation tool for autism diagnosis.
- •2. Children in whom organic brain abnormality or epileptic abnormality were denied by MRI and EEG examination performed less than two and one year prior to rTMS, respectively.
- •3. Children with IQ more than 80.
- •4. Right-handed children judged by Edinburgh Handedness Inventory.
- •5. Children with age of 10 to 15 years when consent are obtained. 6. Children who obtained written informed consent after the detailed explanation.
排除标准
- •1. Those who suffer from physical comorbid disorders except developmental disorders.
- •2. Those who have any instrument including metal in the head except oral cavity.
- •3. Those who have a history of heart, gastrointestinal, chronic renal diseases, head trauma or brain tumors.
- •4. Those who were instrumented with a cardiac pacemaker, a deep brain or a spinal stimulation or drug-delivery pump.
- •5. Those who possess intracranial organic lesions and at increased risk for induction of convulsion.
- •6. Those who have a history of convulsive diseases including febrile seizures, epileptic seizures or epilepsy.
- •7. Those who take medicine that decrease the convulsive threshold such as anti-depressant, anti-psycotic or anti-histamine drugs.
- •8. Those who is judged to be not suitable for participating in the study by responsible or contributing doctors.
研究者
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