Low Pulse Amplitude Focal Electroconvulsive Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Memory (cognitive side effects)
研究概览
简要总结
This protocol proposes a pilot randomized clinical trial to examine whether Low Pulse Amplitude Focal ECT (LAP) has a more favorable cognitive profile compared to conventional unilateral ECT and that it has similar effects as traditional ECT in reducing suicidality. The study will enroll 10 patients recruited from the Medical College of Georgia (at Georgia Regents University/Augusta University, GRU/AU) as the only site of the study. Eligible participants will be randomly assigned (1:1 ratio) to receive a course of either RUL LAP ECT, or conventional RUL ECT.
详细描述
Lower amplitude ECT (LAP) has been shown to induce seizures of adequate duration in a single titration session. This current study is hypothesized to increase stimulation focality, thus hypothetically minimizing cognitive side effects.
The central hypothesis is that LAP has significantly less cognitive adverse effects compared to conventional Right Unilateral (RUL) ECT.
The study will enroll 10 patients recruited from Medical College of Georgia. Patients referred to ECT service in the Medical College of Georgia usually occurs from clinical services and private physicians and the study will recruit patients who are clinically indicated to do ECT. Eligible participants will be randomly assigned (1:1 ratio) to receive a course of either RUL LAP ECT, or conventional RUL ECT.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in whom ECT therapy is clinically indicated
- •Males or females patients over 20 years of age
- •Current DSM-IV criteria for major depressive episode
- •Montgomery-Asberg depression rating scale (MADRS) greater than or equal to 20
- •Use of effective method of birth control for women of child-bearing capacity
- •Patient is medically stable
- •No anticipated need to alter psychotropic medications for the duration of the study
- •Ability of patient to fully participate in the informed consent process
排除标准
- •Unstable or serious medical condition that substantially increases risks of ECT or of cognitive impairment
- •Substance use disorders within 1 week of randomization
- •History of neurological disorder, epilepsy, stroke, brain surgery, metal in the head, history of known structural brain lesion that is deemed to affect cognition or safe ECT treatment
- •Vagal Nerve Stimulator implanted
- •Female patients who are pregnant or plan to be pregnant during the study breast-feeding
- •Implanted devices that make ECT unsafe, or a skull defect
- •Significant cognitive impairment (Mini-Mental State Examination (MMSE) less than 24)
- •ECT in the past 1 months
- •Benzodiazepine use will be limited to no more than 3 mg per day of lorazepam or its equivalents. Antidepressants and antipsychotics will be held constant during the ECT course of the study
研究组 & 干预措施
Low Pulse Amplitude ECT (LAP)
Right Unilateral LAP ECT
干预措施: spectrum 5000Q ECT device (RUL LAP ECT) (Device)
standard Right Unilateral ECT
standard Right Unilateral ECT
干预措施: spectrum 5000Q ECT device (RUL ECT) (Device)
结局指标
主要结局
Memory (cognitive side effects)
时间窗: From Baseline to end of acute course (typically after 4 weeks)
Measured by Autobiographic Memory Interview-Short form (AMI-SF, primary outcome)
Time to reorientation
时间窗: From Baseline to end of acute course (typically after 4 weeks)
Measured by Time to Orientation Test (TRO, primary outcome)
次要结局
- Resilience(From Baseline to end of acute course (typically after 4 weeks))
- Suicidal Ideation(From Baseline to end of acute course (typically after 4 weeks))
- Trauma symptoms(From Baseline to end of acute course (typically after 4 weeks))
- Depression(From Baseline to end of acute course (typically after 4 weeks))
研究者
Nagy Adel Youssef
Associate Professor, Psychiatry and Health Behavior
Augusta University