OPTIMIZATION OF TMS FOR DEPRESSION - COORDINATING CENTER

针对抑郁症的 TMS 优化 - 协调中心

• 批准号: 8171065
• 负责人: MARK S GEORGE
• 金额: $ 0.61万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-01 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8171065
• 关键词: Acute; Adult; Adverse event; Affect; Antidepressive Agents; Applications Grants; Clinical; Computer Retrieval of Information on Scientific Projects Database; Data; Depressed mood; Dose; Electroconvulsive Therapy; Funding; Grant; Guidelines; Individual Differences; Institution; Left; Length; Location; Magnetic Resonance Imaging; Major Depressive Disorder; Measures; Mental Depression; Meta-Analysis; Motor; Neuropsychological Tests; Patients; Pharmaceutical Preparations; Prefrontal Cortex; Protocols documentation; Publishing; Randomized; Research; Research Personnel; Resistance; Resources; Safety; Sample Size; Sampling; Site; Source; Stimulus; Support Groups; United States National Institutes of Health; clinical remission; clinical research site; control trial; cranium; depressive symptoms; randomized trial; repetitive transcranial magnetic stimulation; response

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This resubmission requests support for a 4-year, 4-site, randomized sham-controlled trial of daily left prefrontal repetitive transcranial magnetic stimulation (rTMS) for the acute treatment of major depression, rTMS has shown an antidepressant effect in 20 small sample randomized controlled comparisons, five separate meta analyses of these studies, and in randomized trials with electroconvulsive therapy. However, the sample sizes of these studies have been small and the rTMS stimulus administered may not have been of an adequate dose in terms of the intensity of stimulation or length of treatment in order to demonstrate an optimal antidepressant effect. Considerable skepticism and many questions remain concerning the ultimate clinical meaningfulness of these studies. Recent scientific evidence and pilot data from our groups support the fact that the antidepressant response to rTMS is dose-dependent. The present protocol uses rTMS parameters that maximize the stimulation duration and intensity within the published safety guidelines to treat 240 unipolar depressed adults with moderate levels of treatment resistance. We will investigate the safety and efficacy of repeated daily left prefrontal 5Hz rTMS at 120% of motor threshold (MT) in a 3 week fixed dose trial. In subjects showing an antidepressant response after 3 weeks, rTMS will be administered for up to 6 weeks to achieve remission of clinical symptoms of depression. Patients who do not remit with the initial fixed dose trial will be administered 1Hz rTMS in an open trial over the right prefrontal cortex. Baseline magnetic resonance images will be used to determine the optimal stimulus intensity by adjusting for individual differences in cortical to skull distances. Safety measures will include the most comprehensive neuropsychological testing and adverse event profile used to date. We will also determine the long-term antidepressant effect of TMS in remitters, using a standardized continuation medication protocol over 6 months. Finally, we will evaluate whether neuroanatomic findings on magnetic resonance images, stimulus location, demographic, and/or clinical variables affect clinical response to TMS. [This clinical site grant (CSG) proposal is one of four scientifically identical proposals resubmitted under a CSMD mechanism.]

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 该重新提出要求支持4年的4年，随机的假手术对照试验，该试验每天左前前额叶重复性经颅磁刺激（RTMS），用于对重度抑郁症的急性治疗，RTMS显示了20个小样品随机对照比较的抗抑郁作用，五个单独的对照研究，五个单独的研究分析了这些研究，这些研究与随机性试验和电子疗法进行了电视验证。但是，这些研究的样本量很小，并且在刺激的强度或治疗时间长度方面，施用的RTMS刺激可能没有足够的剂量，以证明最佳的抗抑郁作用。对这些研究的最终临床意义仍然存在很大的怀疑和许多问题。我们小组的最新科学证据和试点数据支持以下事实：抗抑郁药对RTM的反应是剂量依赖的。本协议使用RTMS参数，以最大化已发表的安全指南内的刺激持续时间和强度，以治疗240个单极抑郁症的成年人，具有中等水平的治疗性治疗性。我们将在3周的固定剂量试验中研究以运动阈值（MT）为120％的每日左前5Hz RTM的安全性和功效。在显示3周后显示抗抑郁反应的受试者中，RTMS最多将进行6周，以减轻抑郁症的临床症状。在最初的固定剂量试验中不妥协的患者将在对右前额叶皮层的公开试验中给予1Hz RTM。基线磁共振图像将用于通过调整皮质到颅骨距离的个体差异来确定最佳刺激强度。安全措施将包括最全面的神经心理学测试和迄今为止使用的不良事件概况。我们还将在6个月内使用标准化的持续药方案来确定TMS在汇总中的长期抗抑郁作用。最后，我们将评估在磁共振图像，刺激位置，人口统计学和/或临床变量上的神经解剖学发现是否会影响对TMS的临床反应。 [该临床场地赠款（CSG）提案是在CSMD机制下重新提交的四个科学相同的建议之一。]