NCT02351843终止不适用
Efficacy and Safety of Low Amplitude Electroconvulsive Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Change in California Verbal Learning Test-II
研究概览
简要总结
The purpose of this study is to demonstrate the clinical feasibility of low amplitude electroconvulsive therapy (ECT) to reduce, and possibly eliminate the side effects of ECT by lowering the strength of the ECT stimulus from the conventional 800 mA to 500 mA. Low amplitude ECT could potentially reduce the risks associated with ECT while preserving its unparalleled efficacy. This novel development would remove key obstacles to allow for the wider adoption of ECT as a safe and effective therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects, age 18-70
- •DSM-IV-TR diagnosis of major depressive episode in unipolar or bipolar disorder, confirmed by the MINI-PLUS
- •MMSE total score > 26
- •Referred for ECT
- •Competent to provide informed consent
- •Able to read or comprehend English
排除标准
- •Lifetime history of schizophrenia, schizoaffective disorder, mental retardation
- •Current neurostimulation treatment (e.g., ECT, magnetic seizure therapy, transcranial magnetic stimulation, vagus nerve stimulation, deep brain stimulation)
- •Current alcohol abuse or dependence within past 6 months
- •Current substance abuse or dependence within past 6 months
- •History of central nervous system (CNS) disease
- •Current diagnosis of dementia or delirium
- •MoCA total score < 26
- •Current visual, auditory, or motor impairment that compromises ability to complete evaluations
- •Patients with intracranial implants
- •MRI contraindications: pregnancy, implanted metal, and claustrophobia
结局指标
主要结局
Change in California Verbal Learning Test-II
时间窗: Baseline and within 24 to 48 hours of each ECT session
次要结局
未报告次要终点
研究者
研究点 (2)
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