WebMD reports on Oct. 8, 2008 – The FDA has cleared the NeuroStar TMS brain-stimulating device for treating depressed adults for whom one antidepressant has failed to work.
It’s the first transcranial magnetic stimulation (TMS) device to pass FDA muster. An FDA spokesperson tells WebMD that because the NeuroStar device is not implanted and carries only “moderate” risk, the FDA needed to only “clear” the device and not formally “approve” it. Because of these questions about effectiveness, the panel said the device’s risk/benefit profile was not comparable to the risk/benefit profile of electroconvulsive therapy (ECT), a highly effective treatment with potentially serious side effects. Although the FDA originally intended to clear the NeuroStar device based on equivalence to ECT, the panel rejected this comparison. The FDA then decided to clear NeuroStar on its own merits.
And TMS truly is different from ECT, says psychiatry professor Michael Thase, MD, chief of the mood and anxiety disorders program at the University of Pennsylvania. Thase has served as a consultant to NeuroStar maker Neuronetics Inc. On the company’s behalf, he presented NeuroStar clinical trial data to the 2007 FDA advisory committee.
How well does TMS work? Thase says he’s seen meaningful benefit in patients he’s treated — a benefit also seen in clinical trials.
“The track record for TMS in depression is not 100% successful, but studies document a pattern of evidence that this has a significant treatment benefit,” he says. When, if ever, should a patient give TMS a try?
The FDA clearance is for the same patients who did best in clinical studies: people who did not benefit from one antidepressant medication, but who had not yet tried a second antidepressant.
“It fits in between first- and second-choice therapies and ECT,” Thase says. “You would not use it in a patient for whom the depression was so disabling that hospitalization was required. And you certainly would not use it for someone who had tried antidepressant treatment of appropriate dosage and duration.”
Patients undergoing TMS must be treated five times a week for four to six weeks. Thase says that during this time, his team starts patients on a new antidepressant and weans them from TMS treatment.