Finding Alternatives to Standard Treatment for Attention-Deficit Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- TEACH-2
研究概览
简要总结
Attention-Deficit/Hyperactivity Disorder (ADHD) is characterized by poor attention, impulsivity, hyperactivity and emotional-motivational dysregulation. Here, we will test if theta burst repetitive transcranial magnetic stimulation (rTMS) can reduce the symptoms of ADHD.
详细描述
Background & Rationale Attention-Deficit/Hyperactivity Disorder (ADHD) is characterized by poor attention, impulsivity, hyperactivity and emotional-motivational dysregulation. It has an estimated prevalence of 5% in children. Usually, ADHD in children is treated with stimulant medications, such as methylphenidate. However, these pharmacotherapy treatments have numerous unwanted side effects, including sleep disturbances, appetite changes, and emotional lability, and do not prove to be effective in every case.
A promising and alternative option for reducing ADHD symptoms is non-invasive brain stimulation. Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive brain stimulation which involves the application of a magnetic field to the skull to change the behaviour and function of underlying brain areas. In turn, rTMS leads to positive long-term changes in neurochemical activity, and while studies are limited, some have shown that rTMS can reduce ADHD symptoms in adolescents with ADHD.
Methods Design: Open label TMS trial Primary Outcome: To examine the effect of active rTMS to the right prefrontal cortex on attention as measured by the TEACh-2
Outline:
- Baseline Assessment (MRI Scan, assessment scales, neuropsychological testing)
- rTMS intervention: 5 / week for 4 weeks.
- Post-intervention Assessment (MRI Scan, assessment scales, neuropsychological testing).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ADHD
- •9-15 years old
- •IQ greater than 80
- •English fluency (to enable consent/assent)
- •If on medication, must have been on the same type and dosage for at least 3 months.
排除标准
- •Diagnosis of mania, psychosis, or bipolar disorder
- •Impediments to TMS or MRI (i.e. metal implants in body)
- •Prior electroconvulsive therapy or vagus nerve stimulation
- •Diagnosis of Autism Spectrum Disorder.
研究组 & 干预措施
Active rTMS
Active repetitive TMS
干预措施: rTMS (Device)
结局指标
主要结局
TEACH-2
时间窗: Baseline to week 5
Test of everyday attention in children - 2. Direct assessment of attention abilities in children.
次要结局
- SNAP-18(5 weeks and 52 weeks.)
- PedsQL(Baseline to week 5)
研究者
Kara Murias
Assistant Professor
University of Calgary