The NeuroStar TMS device: conducting the FDA approved protocol for treatment of depression.
The NeuroStar TMS device: conducting the FDA approved protocol for treatment of depression.
复制标题
DOI：
10.3791/2345
复制
发表时间：
2010-11-12
期刊：
影响因子：
--
通讯作者：
Pascual-Leone, Alvaro
中科院分区：
文献类型：
--
作者：
Horvath, Jared C;Mathews, John;Pascual-Leone, Alvaro
Neuronetics NeuroStar经颅磁刺激（TMS）系统是一种II类医疗设备，可以产生短暂的脉冲磁场。这些快速交替的磁场会在大脑皮层的特定区域产生电流，这些区域与大脑的各种生理和功能变化有关。2007年，O'Reardon等人利用NeuroStar设备发表了一项由行业赞助的、多地点、随机、模拟刺激对照临床试验的结果，在该试验中，301名之前对至少一种适当的抗抑郁治疗试验无效的重度抑郁症患者在左背外侧前额叶皮质（DLPFC）上接受了主动或虚假的经颅磁刺激。这些患者在研究期间没有服用药物，每周接受5次经颅磁刺激，持续4-6周。结果表明，一个亚群患者（那些对药物的耐药性相对较小，失败不超过两个良好的药理学试验的患者）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）和其他各种结果测量上显示出统计学上显著的改善。2008年10月，在这些和其他类似结果的支持下，Neuronetics获得了美国食品和药物管理局（FDA）第一个也是唯一一个批准，使用经颅磁刺激疗法设备临床治疗一种特定形式的药物难治性抑郁症（FDA批准K061053）。在本文中，我们将探讨指定的FDA批准的神经之星抑郁症治疗方案（仅在处方下，由有执照的医疗专业人员在门诊或门诊环境中进行管理）。
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).