ADHD PreSMA Response Inhibition Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- TMS-based Short-Interval Intracortical Inhibition (SICI)
研究概览
简要总结
ADHD children have abnormal inhibitory control, meaning they have trouble stopping themselves from doing something they should not do. This ability to control involves an area in the brain called the pre-supplementary motor area (pre-SMA). Scientists have previously shown that the pre-SMA is abnormal in ADHD patients. In this study, we will use Transcranial Magnetic Stimulation (TMS) to stimulate the pre-SMA and determine the effects on measures that are related to inhibitory control.
详细描述
ADHD children (ages 12-17 years) will be recruited. Cognitive testing and basic anatomic brain MRI will be performed during visit 1. During visit 2, baseline TMS-based physiologic measures will be obtained. Children will also complete a behavioral task (stop signal task) while electroencephalography (EEG) data is collected. After these baseline measures, two trains of Intermittent Theta Burst Stimulation (iTBS) will be delivered. (Intermittent Theta Burst Stimulation is a form of repetitive TMS.) The first train of iTBS will be randomized to sham vs. active in a 1:1 ratio. The second train of iTBS is active for all participants. After both iTBS trains are completed, repeat TMS-based measures, stop signal task and EEG data will be collected again. Visit 3 will be one week after visit 2. Visit 3 is a virtual computer-based visit to assess for any potential side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ADHD diagnosis
- •Ages 12-17 years
- •Stimulant use is allowed but must be discontinued 24 hours prior to and during days of TMS visit
排除标准
- •Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, intellectual disability, cerebral palsy, neurodegenerative conditions, hearing impairment, metallic objects in the head or any other serious medical condition
- •Presence of any implanted medical devices (e.g., ports, shunts, stimulators, cochlear implants)
- •For biological females who are post-menarche, current pregnancy based on urine pregnancy test.
- •Baseline problem of hearing impairment or chronic tinnitus
- •Any clinically significant finding on brain MRI
- •History of DSM-5 conduct disorder, major depressive disorder, bipolar disorder, obsessive compulsive disorder, anxiety disorder, psychotic disorder
- •Non-stimulant medication(s) for ADHD (e.g., alpha2 adrenergic agonist, atomoxetine, tricyclics)
- •Neuroleptic/antipsychotic medication(s)
- •Inability to undergo MRI
- •Active suicidality, history of suicidality, or high risk for suicide as assessed by a study physician
- •Substance abuse or dependence within the past year, based on 1) separate screening process of asking parent/guardian and participant, and 2) positive urine drug screen. Exception will be made for positive urine drug screen due to prescribed ADHD medication
研究组 & 干预措施
Active repetitive TMS
干预措施: Active repetitive TMS (Device)
Sham repetitive TMS
干预措施: Sham repetitive TMS (Device)
结局指标
主要结局
TMS-based Short-Interval Intracortical Inhibition (SICI)
时间窗: Immediately after each iTBS train
This is a measure of primary motor cortex inhibitory activity.
TMS-based Cortical Silent Period (cSP)
时间窗: Immediately after each iTBS train
This is a measure of primary motor cortex inhibitory activity.
EEG-based alpha activity
时间窗: Immediately after each iTBS train
This is a measure of alpha-band activity during performance of stop signal task.
EEG-based beta activity
时间窗: Immediately after each iTBS train
This is a measure of beta-band activity during performance of stop signal task.
次要结局
- Stop Signal Reaction Time(Immediately after each iTBS train)