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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.1,2,3
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.4
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 5,6,7, 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).
TMS is typically applied daily for a period of 4–6 weeks. Recent data suggests some patients may be prone to symptomatic relapse after 4–6 months.8 If this occurs, practitioners may want to consider maintenance sessions to prolong effect. This treatment has been effective in approximately 60% of the patients treated.
When considering TMS as a potential therapeutic intervention for depression, it is important to recognize the FDA approved protocol is highly specified. To be concrete, FDA approval is limited to 10 Hz suprathreshold stimulation applied daily for 4–6 weeks using the NeuroStar device upon patients who have failed to achieve satisfactory improvement from one, but no more than one, adequate antidepressant medication trials during the current depressive episode. At this point, utilization of any alternate stimulation pattern, alternate time course, alternate device, or alternate patient population is considered off-label.
As results continue to be generated in support of the efficacy of TMS treatment5,6,7, new data is revealing the possibility of symptomatic relapse occurring 4–6 months after treatment cessation. As of this publication, there are no approved maintenance protocols. Therefore, issues concerning additional treatment and/or effect maintenance must be considered and monitored closely by individual practitioners.
Disclosures: The video production of this article was sponsored by Neuronetics, which produces instruments used in these studies.