Correlating Electroconvulsive Therapy Response to Electroencephalographic Ictal Complexes and Postictal Markers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Duration of Central Positive Complexes during ECT treatments.
研究概览
简要总结
Single-center study to determine the relationship between changes in depression symptoms and electroencephalographic (EEG) patterns induced by electroconvulsive therapy (ECT)
详细描述
Electroconvulsive therapy (ECT) is an effective treatment for many psychiatric illnesses, including major depressive disorder. While effective, objective markers have not been developed to predict clinical outcome trajectories following ECT. This is important given the risks and costs incurred during a full treatment course. Electroencephalography (EEG) is typically employed to monitor the generation and termination of ECT-induced seizures but leverage of markers toward prognostication remains a future goal. The investigators have characterized two distinct EEG patterns associated with ECT-induced generalized seizures and have two sleep markers that may serve as markers for predicting response to treatment. Central Positive Complexes (CPCs) are large ictal complexes with a scalp topology of voltage declining from the top of the head. CPCs are localized to cortical areas that are involved in the formation of sleep spindles and slow wave sleep. A pattern of low-voltage activity, known as post-ictal generalized electroencephalographic suppression (PGES), is frequently used to document termination of these seizures. Additionally, two EEG markers of sleep microstructure may have utility given their association with synaptic plasticity, a process presumably invoked over the course of ECT-induced recovery from psychiatric illness as pathologic neural circuitry undergoes reconfiguration. These two markers, sleep spindles and slow waves show altered expression patterns in patients with psychiatric disorders, and thus may be useful as objective markers of ECT responsiveness. None of the above EEG markers have been explored for an association to interval changes in disease severity over the course of ECT. This project will incisively probe the relationships between temporal trajectories of major depressive disorder severity and longitudinal measurements of ictal and postictal EEG markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age 18 years or greater
- •Referral for ECT index course for treatment-resistant depression (unipolar major depressive disorder or bipolar depression), major depressive disorder with psychotic symptoms, schizophrenia or schizoaffective being treated for a depressed episode, unspecified depression
排除标准
- •Schizophrenia or schizoaffective disorder not being treated for a depressed episode.
结局指标
主要结局
Duration of Central Positive Complexes during ECT treatments.
时间窗: Up to 8 weeks during patients ECT treatment course
Total time (in seconds) during the ictal period for which CPCs are present in the EEG immediately following seizure induction until termination of the seizure. Range of values: 0 - 300 seconds
Duration of PGES during ECT treatments.
时间窗: Up to 8 weeks during patients ECT treatment course
Total time (in seconds) during the postictal period for which PGES is present in the EEG immediately following seizure termination for up to 5 minutes. Range of values: 0 - 300 seconds
Duration of Central Positive Complexes during ECT treatments.
时间窗: Up to 8 weeks during patients ECT treatment course
Total time (in seconds) during the ictal period for which CPCs are present in the EEG immediately following seizure induction until termination of the seizure. Range of values: 0 - 300 seconds
Duration of PGES during ECT treatments.
时间窗: Up to 8 weeks during patients ECT treatment course
Total time (in seconds) during the postictal period for which PGES is present in the EEG immediately following seizure termination for up to 5 minutes. Range of values: 0 - 300 seconds
Density of EEG sleep spindles during non-rapid eye movement (NREM) stages N2 on evenings following ECT treatments.
时间窗: Up to 8 weeks during patients ECT treatment course
The total number of EEG sleep spindles per minute present during N2 sleep. Range of values: 0 - 60 spindles/min
Slow wave activity (SWA) during N3 sleep on evenings following ECT treatments
时间窗: Up to 8 weeks during patients ECT treatment course
Total power of EEG slow waves per minute present during the first identified cycle of N3 sleep Range of values: 0 - 50 dB/min
Interval change in Quick Inventory of Depressive Symptomatology-16 Item Self Report (QIDS-SR16) between ECT sessions.
时间窗: Up to 8 weeks during patients ECT treatment course
16 item Self-report questionnaire that best describes the participant's depressive symptoms over the last seven days. Scale: 0=never or do not, 3=nearly all the time, or the highest level of time listed on the question.
次要结局
未报告次要终点