Horvath Jared C, Mathews John, Demitrack Mark A, Pascual-Leone Alvaro
Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, USA.
J Vis Exp. 2010 Nov 12(45):2345. doi: 10.3791/2345.
The Neuronetics NeuroStar Transcranial Magnetic Stimulation (TMS) System is a class II medical device that produces brief duration, pulsed magnetic fields. These rapidly alternating fields induce electrical currents within localized, targeted regions of the cortex which are associated with various physiological and functional brain changes. In 2007, O'Reardon et al., utilizing the NeuroStar device, published the results of an industry-sponsored, multisite, randomized, sham-stimulation controlled clinical trial in which 301 patients with major depression, who had previously failed to respond to at least one adequate antidepressant treatment trial, underwent either active or sham TMS over the left dorsolateral prefrontal cortex (DLPFC). The patients, who were medication-free at the time of the study, received TMS five times per week over 4-6 weeks. The results demonstrated that a sub-population of patients (those who were relatively less resistant to medication, having failed not more than two good pharmacologic trials) showed a statistically significant improvement on the Montgomery-Asberg Depression Scale (MADRS), the Hamilton Depression Rating Scale (HAMD), and various other outcome measures. In October 2008, supported by these and other similar results, Neuronetics obtained the first and only Food and Drug Administration (FDA) approval for the clinical treatment of a specific form of medication-refractory depression using a TMS Therapy device (FDA approval K061053). In this paper, we will explore the specified FDA approved NeuroStar depression treatment protocol (to be administered only under prescription and by a licensed medical profession in either an in- or outpatient setting).
Neuronetics NeuroStar经颅磁刺激（TMS）系统是一种II类医疗器械，可产生持续时间短暂的脉冲磁场。这些快速交变磁场会在大脑皮层的局部目标区域内诱发电流，而这些区域与各种生理和功能性脑变化相关。2007年，奥雷登等人使用NeuroStar设备发表了一项由行业赞助、多中心、随机、假刺激对照的临床试验结果，该试验中301名重度抑郁症患者此前至少一次充分的抗抑郁治疗试验均无效，他们在左侧背外侧前额叶皮层（DLPFC）接受了主动或假TMS治疗。研究时未服用药物的患者在4至6周内每周接受5次TMS治疗。结果表明，一部分患者（那些对药物相对不太耐药、不超过两次有效药物试验失败的患者）在蒙哥马利-阿斯伯格抑郁量表（MADRS）、汉密尔顿抑郁评定量表（HAMD）以及其他各种结局指标上有统计学意义的改善。2008年10月，在这些及其他类似结果的支持下，Neuronetics获得了美国食品药品监督管理局（FDA）对使用TMS治疗设备临床治疗特定形式的药物难治性抑郁症的首个也是唯一批准（FDA批准文号K061053）。在本文中，我们将探讨FDA批准的特定NeuroStar抑郁症治疗方案（仅在处方下由有执照的医疗专业人员在门诊或住院环境中实施）。
