Meditation Accelerated Brain Stimulation for Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Change from baseline Clinical Depression (Remission)
研究概览
简要总结
Repetitive Transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. The ultimate goal of this treatment is to increase excitability and long-term plasticity in DLPFC, a brain region shown to be hypo-active in depression. Unfortunately, rTMS only has low to moderate efficacy; remission rates for patients range from ~15-30% in large randomized controlled trials. The focus of this research is to develop a next-generation rTMS protocol that is guided by the basic principles underlying brain plasticity, in order to improve the efficacy of rTMS for the treatment of depression. Specifically, in this study the investigators will test rTMS paired with a depression-relevant cognitive state of internal attention.
详细描述
Repetitive Transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. The ultimate goal of this treatment is to increase excitability and long-term plasticity in DLPFC, a brain region shown to be hypo-active in depression. Unfortunately, rTMS only has low to moderate efficacy; remission rates for patients range from ~15-30% in large randomized controlled trials. The focus of this research is to develop a next-generation rTMS protocol that is guided by the basic principles underlying brain plasticity, in order to improve the efficacy of rTMS for the treatment of depression. Specifically, in this study the investigators will test rTMS paired with a depression-relevant cognitive state of internal attention. Meditative internal focus has been shown to benefit depression. Our own research shows that the neural correlates of attention-to-breath are associated with greater mindfulness. Hence, in this study we will pair breath training with rTMS neuro-stimulation.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate to severe depression (PHQ-9 scale score >9 with confirmation using the Structured Clinical Interview for DSM-5 Disorders)
- •treatment refractory to antidepressants (i.e. failed 1-3 antidepressants in current episode) or intolerant to antidepressants (i.e. tried 2 antidepressant of inadequate dose/duration in current episode)
排除标准
- •active substance abuse/dependence
- •psychotic disorders
- •any factor that increases risk of TMS (metal implants/history of stroke/seizure disorder).
- •displaying acutely suicidal behaviors on the Columbia Suicide Severity Rating Scale.
研究组 & 干预措施
Medi1TMS
rTMS theta-burst protocol paired with a consistent attention-to-breath task
干预措施: Medi1TMS (Device)
Medi2TMS
rTMS theta-burst protocol paired with an intermittent deep breathing task
干预措施: Medi2TMS (Device)
结局指标
主要结局
Change from baseline Clinical Depression (Remission)
时间窗: up to 6 weeks
PHQ9 depression scale
Change from baseline brain activity in attention-to-breath task
时间窗: up to 6 weeks
Electroencephalography (EEG) power in attention-to-breath task
Change From Baseline Clinical Depression (Remission)
时间窗: up to 6 weeks
Remission is defined by achieving \<5 score on the Patient Health Questionnaire 9-item depression scale at post-intervention. This scale ranges in score from 0-27; higher score is worse depression.
Change From Baseline Brain Activity in Attention-to-breath Task
时间窗: up to 6 weeks
Change from baseline brain activity is specifically change in source-localized electroencephalography (EEG) alpha band power. The unit of measure is log (uA/mm\^2), which represents the transformation of EEG signals recorded at scalp electrodes in microvolts into a log-scaled estimate of cortical current source density after source reconstruction. A value of 0 means the current density is exactly 1 since log(1) = 0. Negative values indicate weak cortical source currents fractional to a microampere (e.g. -1 equals 0.1 uA/mm\^2). Positive values represent stronger activity.
次要结局
未报告次要终点
研究者
Jyoti Mishra
Assistant Professor
University of California, San Diego