Transcranial Magnetic Stimulation in the Treatment of Major Depressive Disorder

Abstract

Background: Transcranial magnetic stimulation (TMS) has demonstrated efficacy in the treatment of major depressive disorder; however, prior studies have provided only partial safety information. We examined the acute efficacy of TMS in a randomized sham-controlled trial, under openlabel conditions, and its durability of benefit. Method: Aggregate safety data were obtained from a comprehensive clinical development program examining the use of TMS in the treatment of major depressive disorder. There were 3 separate clinical protocols, including 325 patients from 23 clinical sites in the United States, Australia, and Canada. Active enrollment occurred between January 2004 and August 2005. Adverse events were assessed at each study visit by review of spontaneous reports with separate reporting of serious adverse events. Safety assessments were also completed for cognitive function and auditory threshold. Assessment of disease-specific risk included the potential for worsening of depressive symptoms. Finally, the time course and accommodation to the most commonly appearing adverse events were considered. Results: TMS was administered in over 10,000 cumulative treatment sessions in the study program. There were no deaths or seizures. Most adverse events were mild to moderate in intensity. Transient headaches and scalp discomfort were the most common adverse events. Auditory threshold and cognitive function did not change. There was a low discontinuation rate (4.5%) due to adverse events during acute treatment. Conclusions: TMS was associated with a low incidence of adverse events that were mild to moderate in intensity and demonstrated a largely predictable time course of resolution. TMS may offer clinicians a novel, well-tolerated alternative for the treatment of major depressive disorder that can be safely administered in an outpatient setting.

Evolving refractory major depressive disorder diagnostic and treatment paradigms: toward closed-loop therapeutics

“…By noninvasively activating target cortical regions, TMS allows investigators to selectively study brain function in a simplified and relatively safe manner (Figiel et al, 1998; Klein et al, 1999). In the last few decades it has received considerable interest as a therapeutic tool in a variety of neurological disorders, stemming from its favorable spatial selectivity over ECT, noninvasive nature, and generally tolerable side effects (Figiel et al, 1998; Klein et al, 1999; Janicak et al, 2008). As a result, TMS is now used as an FDA-approved treatment option for refractory MDD.…”

The Effects of Repetitive Transcranial Magnetic Stimulation on Cognitive Performance in Treatment-Resistant Depression. A Systematic Review

“…Several randomized, sham-controlled trials designated to investigate the antidepressant efficacy of rTMS also reported interesting findings regarding the effects of rTMS on cognitive performance [12,23,24,25,26,27,28,29,30,31,32,33,34]. However, given the limited availability of neurocognitive measures and the open nature of most available studies, to what extent rTMS may be really beneficial on neurocognitive performance is still unknown.…”

Acute Frontal Lobe Dysfunction Following Prefrontal Low-Frequency Repetitive Transcranial Magnetic Stimulation in a Patient with Treatment-Resistant Depression

“…Nevertheless, we cannot exclude similar rTMS-induced cognitive dysfunctions as the one observed in our patient might have passed unnoticed. Indeed, some of the side effects of rTMS, such as agitation, hypomania, or mixed depressive episode, share core symptoms with a frontal lobe syndrome, and thus could easily be misdiagnosed (7, 8, 14, 15). Interestingly, all neurologic symptoms observed resolved shortly after the discontinuation of LF-rTMS and sertraline, without the use of specific therapeutics such as mood stabilizers.…”