Depression Treatment Turns a Neuromodulatory Corner: FDA Clears TMS Device

The FDA has cleared the first transcranial magnetic stimulation (TMS) device (Neuro- Star) for the treatment of major depressive disorder in adults who show no improvement after an adequate trial of a single antidepressant. The TMS device is not implanted and is deemed to have only “moderate” risks (it is nonsystemic and noninvasive).

In January 2007, an FDA panel deemed the TMS device “clinically ineffective” with “marginal” results when compared with electroconvulsive therapy (ECT). Although ECT is highly effective in patients who do not respond to antidepressant treatment, it has the potential for serious adverse effects, such as short-term amnesia and other cognitive deficits. The TMS device induces a much smaller electric current to stimulate nerve cells at specific points of the brain and does not induce seizure or loss of consciousness; it is also administered on an outpatient basis. However, the device is not as powerful as ECT and is currently being used to treat patients with relatively mild depression who have not responded to a trial of a single antidepressant, but not 2 or more.

Michael Thase, MD, who served as a consultant to Neuronetics, Inc (the makers of Neuro- Star), presented clinical trial data to the FDA advisory panel in 2007. In a report from Web-MD, Thase stated, “TMS is in no way equivalent to ECT in terms of efficacy nor in terms of safety. TMS is less effective but substantially safer than ECT.”¹ Philip G. Janicak, MD, Principal Investigator in the NeuroStar clinical trials, commented that it is “particularly noteworthy”that NeuroStar presented effective and safe results free of systemic adverse effects.²