Comparing three Electrode Placements to Optimize ECT

比较三种电极放置以优化 ECT

• 批准号: 6572622
• 负责人: Charles H Kellner
• 金额: $ 19.22万
• 依托单位: UNIV OF MED/DENT OF NJ-NJ MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-16 至 2006-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6572622
• 关键词: clinical research; clinical trials; cognition; cognition disorders; electroconvulsive therapy; electrodes; electroencephalography; electromyography; human subject; human therapy evaluation; iatrogenic disease; major depression; neuropsychological tests; outcomes research; patient oriented research; quality of life

DESCRIPTION (provided by applicant): Electroconvulsive therapy remains an important treatment for severely depressed patients who do not respond adequately to, or are intolerant of, antidepressant medication. As the prevalence of major depression increases, particularly in the geriatric population, the need for effective treatments is an urgent public health concern. Despite refinements in technique, the cognitive impairment associated with ECT remains a serious concern for many patients. Traditionally, ECT has been administered with one of two standard techniques: 1) bilateral (bitemporal) electrode placement or 2) right unilateral electrode placement. Bilateral electrode placement has greater efficacy but causes more cognitive impairment, while right unilateral electrode placement is less effective for some patients but causes less cognitive impairment. Recently, two innovative techniques have shown promise in preliminary studies: 1) right unilateral ECT administered at much higher electrical dose, which may achieve efficacy equivalent to bilateral ECT and 2) a novel electrode placement (bifrontal) which may combine the beneficial properties of both bilateral and unilateral ECT. We propose a double blind, randomized, controlled clinical trial comparing the standard technique of bilateral ECT with two novel techniques - high-dose unilateral ECT and bifrontal ECT. The primary aims of the study are to compare the three treatments in terms of 1) antidepressant efficacy and 2) cognitive effects during and at the end of the treatment course, and over a two-month naturalistic follow-up period. An additional aim is to compare the treatments in terms of quality of life over two months. In this study, 360 patients with major depression are randomized over 4 years at 4 sites. Assessments are the Hamilton Rating Scale for Depression (HRSD), a comprehensive neuropsychological test battery, and quality of life outcome measures. Provisions are made for assuring the ongoing quality of treatments and assessments. The investigators are experienced ECT providers and researchers who are now successfully collaborating on an ongoing NIMH-funded trial of continuation ECT vs. pharmacotherapy (MH55489, MH55486, MH55484). The proposed study will be the first direct comparison of the three types of ECT and will inform psychiatrists about the optimal technique of ECT. The results of this study will promote more effective and safer treatment of the most severely ill depressed patients.

描述（由申请方提供）：电休克治疗仍然是对抗抑郁药物反应不充分或不耐受的严重抑郁患者的重要治疗方法。 随着重度抑郁症患病率的增加，特别是在老年人群中，对有效治疗的需求是一个紧迫的公共卫生问题。 尽管技术上有所改进，但与ECT相关的认知障碍仍然是许多患者的严重问题。 传统上，ECT采用两种标准技术之一进行管理：1）双侧（双颞）电极放置或2）右侧单侧电极放置。 双侧电极放置具有更大的疗效，但引起更多的认知障碍，而右侧单侧电极放置对某些患者的疗效较差，但引起的认知障碍较少。 最近，两种创新技术在初步研究中显示出前景：1）以高得多的电剂量给予右侧单侧ECT，其可实现与双侧ECT相当的疗效; 2）新型电极放置（双额叶），其可联合收割机双侧和单侧ECT的有益特性。 我们提出了一个双盲，随机，对照临床试验比较标准技术的双边ECT与两种新的技术-高剂量单侧ECT和双额叶ECT。 该研究的主要目的是比较三种治疗方法在1）抗抑郁疗效和2）治疗过程中和治疗结束时的认知效果，以及两个月的自然随访期。 另一个目的是比较两个月内的生活质量。 在这项研究中，360例重性抑郁症患者在4年内随机分布在4个地点。 评估是汉密尔顿抑郁量表（HRSD），一个全面的神经心理测试电池，和生活质量的结果措施。 为保证治疗和评估的持续质量作出了规定。 研究人员是经验丰富的ECT提供者和研究人员，他们现在正在成功地合作进行一项由NIMH资助的持续ECT与药物治疗（MH 55489，MH 55486，MH 55484）的试验。 这项拟议中的研究将是第一次直接比较三种类型的ECT，并将告知精神科医生ECT的最佳技术。 这项研究的结果将促进对最严重的抑郁症患者进行更有效、更安全的治疗。