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Abstract

In the past decade, advances in science have produced several novel neuromodulation therapies. As novel neuromodulation therapies are introduced, it is imperative that clinicians in the field of Psychology and Psychiatry carefully weigh the evidence base, risks and benefits before applying these new treatments to our patients Neuromodulation therapies that have emerged include: (1) Transcranial Magnetic Stimulation (rTMS or TMS); Vagal Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), and; Transcranial Direct Current Stimulation (tCDS) [1]. These four neuromodulation therapies have been proposed as treatments for several neuropsychiatric disorders, specifically: (1) TMS for recurrent major depressive disorder (MDD) [2,3] and refractory auditory hallucinations/persistent negative symptoms in schizophrenia [4][5][6]; (2) VNS for refractory MDD [7]; (3) DBS for treatment-refractory obsessive-compulsive disorder (OCD) [8] and treatment-refractory unipolar and bipolar depression [9,10], as well as; tCDS for MDD [11,12] and schizophrenia [13]. The evidence to support the use of these neuromodulation modalities for these indications varies in strength. It is well beyond the scope of this editorial to summarize, analyze and critique the data supporting every potential neuromodulation treatment for every possible neuropsychiatric disorder. Yet, the current evidence, combined with clinical experience, is now adequate to comment on the use of TMS for MDD. for active treatment which reached statistical significance at a very high level (z=6.52, p<0.0001). These results suggested that the effect size was significant and robust as well as being comparable to at least a subset of commercially available antidepressant drugs.The industry sponsored study [16] that lead to the aforementioned 2008 FDA approval: had a randomized doubleblind, multisite design; examined 301 medication-free patients with MDD who had previously failed an adequate trial of one antidepressant; randomized 155 patients to active TMS (with the proprietary Neuronetics system) and 146 patients to sham TMS; showed in the results that active TMS was significantly superior to sham TMS, and; concluded that transcranial magnetic stimulation was effective in treating major depression. A nonindustry sponsored replication study [3] using a non-proprietary system: had a prospective, multisite, randomized, active shamcontrolled design; 190 antidepressant drug-free patients with unipolar MDD were randomized to active TMS or sham TMS (with a non-proprietary system); showed an overall retention rate of 88% (90% sham and 86% active); demonstrated a significant effect of active TMS treatment on the proportion of remitters (14.1% active rTMS and 5.1% sham) (P=.02); the odds of attaining remission was 4.2 times greater with active TMS than with sham; concluded that left prefrontal rTMS as monotherapy produced statistically significant and clinically meaningful antidepressant therapeutic effects greater than sham with minimal side effects. Subsequently, another metanalysis...