Low Pulse Amplitude Seizure Therapy (LAP-ST Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Feasibility (by successfully inducing therapeutic seizures during LAP-ST course)
研究概览
简要总结
This study assesses the feasibility of a full course of Low Pulse Amplitude-Seizure Therapy (LAP-ST) (primary outcome).
详细描述
This is hypothesized to increase stimulation focality, thus minimizing cognitive side effects compared to conventional ECT. The study will enroll 22 patients recruited from the Behman Hospital, Cairo, Egypt. Patients referred to ECT service in the Behman Hospital who are clinically indicated to do ECT for major depressive episode of a mood disorder or psychotic episode of a primary psychotic disorder will be approached. Eligible participants who signed informed consent will be included to receive a course of Right Unilateral Ultrabrief LAP-ST.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECT clinically indicated
- •Males or females over 22 to 80 years of age
- •Use of effective method of birth control for women of child-bearing capacity
- •Patient is medically stable
- •Capacity of patient to fully participate in the informed consent process as evaluated by their clinician
排除标准
- •Current unstable or serious medical condition, or any co-morbid medical condition that substantially increases the risks of ECT
- •History of conditions that may make ECT unsafe such as metal in the head, or a skull defect
- •Female patients who are currently pregnant or plan to be pregnant during the study
结局指标
主要结局
Feasibility (by successfully inducing therapeutic seizures during LAP-ST course)
时间窗: From first to last session of LAP-ST course (average approximately 2 weeks)
Measured by: the elicitation of therapeutic seizure in the brain and assessed by using EEG
次要结局
- Memory (cognitive side effects)(From Baseline to end of acute course (average 2 weeks))
- Time to reorientation(From Baseline to end of acute course (average 2 weeks))
- Efficacy(From Baseline to end of acute course (average 2 weeks))