Brain Stimulation Laboratory, Psychiatry Department, Medical University of South Carolina, USA.
J ECT. 2011 Mar;27(1):18-25. doi: 10.1097/YCT.0b013e3181ce1a8c.
Daily left prefrontal repetitive transcranial magnetic stimulation (rTMS) recently received Food and Drug Administration (FDA) approval for the treatment of depression and offers an alternative to traditional approaches. This approval was based on a study using 3000 stimuli per day (15,000 stimuli per week) in adults with unipolar depression not taking antidepressant medications. Several meta-analyses suggest a dose-response relationship with TMS. This study was carried out before US FDA approval to test the safety, tolerability, and effectiveness of adjunctive high-dose left prefrontal rTMS in a clinical setting with particular attention to safety of higher doses and potential interactions with antidepressant medications, speed of response, and effects on suicidality.
We enrolled 19 patients who were in a current major depressive episode with treatment-resistant unipolar or bipolar depression and treated them in their acute episode and in a maintenance fashion for 18 months. The patients received daily left prefrontal rTMS at 120% resting motor threshold, 10 Hz, 5 seconds on, and 10 seconds off and for a mean of 6800 stimuli per session (34,000 stimuli per week), more than twice the dose delivered in the pivotal FDA trial. All patients continued antidepressant medication throughout the rTMS treatment; thus rTMS was an adjunctive treatment. We measured adverse effects, depression, quality of life, suicidal ideation, and social and physical functioning.
These higher rTMS doses were well tolerated without significant adverse effects or adverse events. All measured dimensions showed improvement, with many showing improvement in 1 to 2 weeks. Of perhaps most importance, suicidal ideation diminished in 67% of the patients after just 1 week.
These uncontrolled data suggest that higher doses of daily left prefrontal rTMS may safely be used in outpatients with major depressive episode even as an adjunctive treatment.
每日左侧前额重复经颅磁刺激（rTMS）最近获得美国食品和药物管理局（FDA）批准用于治疗抑郁症，为传统方法提供了一种替代方案。该批准基于一项针对未服用抗抑郁药物的单相和双相抑郁症成人患者每天使用 3000 次刺激（每周 15000 次刺激）的研究。几项荟萃分析表明 rTMS 存在剂量反应关系。这项研究在美国 FDA 批准之前进行，旨在测试辅助性高剂量左侧前额 rTMS 在临床环境中的安全性、耐受性和有效性，特别关注更高剂量的安全性以及与抗抑郁药物的潜在相互作用、反应速度和对自杀意念的影响。
我们招募了 19 名处于当前单相或双相抑郁症发作且伴有治疗抵抗的重度抑郁发作的患者，并在急性发作和 18 个月的维持治疗中对他们进行治疗。患者接受每日左侧前额 rTMS 治疗，刺激频率为 10Hz，刺激时长为 5 秒 ON 和 10 秒 OFF，平均每个疗程 6800 次刺激（每周 34000 次刺激），这是关键 FDA 试验中给予剂量的两倍多。所有患者在 rTMS 治疗期间继续服用抗抑郁药物；因此，rTMS 是一种辅助治疗。我们测量了不良反应、抑郁、生活质量、自杀意念以及社会和身体功能。
这些更高剂量的 rTMS 耐受性良好，没有明显的不良反应或不良事件。所有测量维度均显示出改善，许多在 1 至 2 周内就出现了改善。也许最重要的是，67%的患者在仅仅 1 周后自杀意念就减少了。
这些未对照数据表明，即使作为辅助治疗，每日左侧前额 rTMS 的更高剂量也可以安全地用于门诊重度抑郁发作患者。
