Theta Burst Stimulation for Refractory Depression in Autism Spectrum Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change-from-baseline at 4 weeks in mean Hamilton Depression Rating Scale (HDRS-17) score.
研究概览
简要总结
In this research study the investigators aim to learn more about the therapeutic effects of a newer form of non-invasive transcranial magnetic stimulation (TMS), called theta burst simulation (TBS), on refractory depression in Autism Spectrum Conditions.
详细描述
The overarching goal of this study is to examine treatment effects and elucidate the physiological biomarkers of a newer form of non-invasive brain stimulation therapy on refractory depression in a sample of participants with ASC (autism spectrum condition).
Aim 1: To compare the efficacy of 30-sessions of bilateral (BL) versus unilateral (UL) Theta Burst Stimulation to the dorsolateral prefrontal cortex (DLPFC) on depression severity in youth/young adults with ASC and co-occurring refractory major depressive disorder (MDD).
Aim 2: To identify physiological markers of target engagement of successful response to either UL or BL on depression severity in youth with ASC and co-occurring refractory MDD. These physiological markers include high-resolution electroencephalography (EEG) markers, social eye-tracking, and handgrip strength (collected via NIH toolbox's motor toolbox domain).
Aim 3: To identify feasibility of BL and UL in participants with ASC including systematic measures of safety and tolerability. This includes clinical measures such as rate of hospitalization and medication use.
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
- None
入排标准
- 年龄范围
- 12 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed on the autism spectrum
- •Have been diagnosed with depression and have failed one or more evidence-based antidepressant treatments (e.g. a Selective Serotonin Reuptake Inhibitor, talk therapy like Cognitive Behavioral Therapy)
- •Do not have an intellectual disability
排除标准
- •Substance use disorder
- •Presence of metallic foreign bodies or implanted medical devices
- •History of epilepsy
- •Prior rTMS treatment
- •For female subjects of child bearing potential, current pregnancy
结局指标
主要结局
Change-from-baseline at 4 weeks in mean Hamilton Depression Rating Scale (HDRS-17) score.
时间窗: 4 weeks post-treatment
The HDRS-17 is a valid and reliable measure that assesses severity of, and change in, depressive symptoms. HDRS-17 scores range from 0-52, with scores of 0-7 indicating absence or remission of depression, 7-17 indicating mild depression, 18-24 indicating moderate depression, and scores at or over 25 indicating severe depression.
Change-from-baseline at 4 weeks in mean and Beck Depression Inventory (BDI-II) scores.
时间窗: 4 weeks post-treatment
The BDI-II is a valid and reliable measure for assessing the severity of depressive symptoms. BDI-II scores range from 0-63, with scores of 0-10 indicating absence or remission of depression, 11-16 indicating mild mood disturbance, 17-20 indicating borderline clinical depression, 21-30 indicating moderate depression, 31-40 severe depression, and scores over 40 indicating extreme depression.
次要结局
- Change-from-baseline at 4 weeks in handgrip strength or relative handgrip strength.(4 weeks post-treatment)
- Change-from-baseline at 4 weeks in physiological markers via the use of high-resolution electroencephalography (EEG).(4 weeks post-treatment)
研究者
Ernest Pedapati, MD
Associate Professor
Children's Hospital Medical Center, Cincinnati