Washington The government has approved the first noninvasive brain stimulator to treat depression - a device that beams magnetic pulses through the skull.
If it sounds like science-fiction, well, those woodpecker-like pulses trigger small electrical charges that spark brain cells to fire. Yet it doesn't cause the risks of surgically implanted electrodes or the treatment of last resort, shock therapy.
Called transcranial magnetic stimulation or TMS, this gentler approach isn't for everyone. The Food and Drug Administration approved Neuronetics Inc.'s NeuroStar therapy specifically for patients who had no relief from their first antidepressant, offering them a different option than trying pill after pill.
While there's a big need for innovative approaches - at least one in five depression patients is treatment-resistant - the question is just how much benefit TMS offers.
The FDA cleared the prescription-only NeuroStar based on data that found patients did modestly better when treated with TMS than when they unknowingly received a sham treatment that mimicked the magnet. It was a study fraught with statistical questions that concerned the agency's own scientific advisers.
The National Institutes of Health has an independent study under way now that tracks 260 patients and may have initial results as early as next year.
TMS is expected to cost $6,000 to $10,000, depending on how many treatments a patient needs.