Effect of Intermittent TBS on Children With ADHD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- ADHD-RS
研究概览
简要总结
Attention Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder characterized by persistent symptoms of attention deficit and/or hyperactivity/impulsivity . Currently, the first line drugs for treating ADHD are central stimulants such as Tomoxetine and Guanfaxine. However, there is a risk of drug abuse and misuse, which often affects sleep and appetite, only 50% of patients can fully tolerate. This project uses the iTBS stimulation on weekends, children with ADHD finish scale evaluation, magnetic resonance imaging analysis, and cognitive function before and after stimulation, This study explores its therapeutic effect on attention deficit in children and adolescents with ADHD.
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of ADHD in accordance with DSM-V;
- •Age 6-12 years old, regardless of gender
- •Right-handed
- •Han nationality or born in the Han nationality Ghetto
- •The course of the disease is greater than 6 months
- •Webster children's intelligence ≥ 70
- •The patient's guardian agrees and signs an informed consent form.
排除标准
- •Concomitant mental disorders such as anxiety and depression;
- •Widespread developmental disorders and other neurological developmental related disorders;
- •Complication with other important organ diseases such as heart and lungs;
- •Suffering from diseases such as epilepsy and tic disorder;
- •Individuals who cannot tolerate rTMS treatment or cannot cooperate with treatment.
- •Patients taking psychoactive drugs, antipsychotics, antidepressants, or mood stabilizers 3 months prior to enrollment or during rTMS treatment; In addition to the minimum effective therapeutic dose of Tomoxetine (1.2-1.4 mg • kg/day), there has been systematic use of first-line ADHD drugs in clinical practice Webster's intelligence<70
- •Implantation of metal and electronic components in the body (excluding the oral cavity), such as pacemakers;
结局指标
主要结局
ADHD-RS
时间窗: 4 weeks
Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS), range from 0 to 54 points. The high scores means the worse outcome.
次要结局
- fMRI(4 weeks)
- Stroop color-wordtask (SCWT)(4 weeks)
- TMT task(4 weeks)
研究者
Hu ShaoHua
professor
First Affiliated Hospital of Zhejiang University