FDA Approves Magnets on Brain to Treat Depression

WASHINGTON - The government has approved the first noninvasive brain stimulator to treat depression -- a device that beams magnetic pulses through the skull.

Those 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.

"We're opening up a whole new area of medicine," says Dr. Mark George of the Medical University of South Carolina in Charleston, who helped pioneer use of TMS in depression. "There's a whole field now that's moving forward of noninvasive electrical stimulation of the brain."

There's a big need for innovative approaches because at least one in five depression patients is treatment-resistant.

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.

TMS is expected to cost $6,000 to $10,000, depending on how many treatments a patient needs, says Dr. Philip Janicak of Rush University Medical Center in Chicago, who helped lead the NeuroStar study. That's far more expensive than medication, yet thousands cheaper than invasive depression devices.

Neuroscientists have been using TMS for years as a research tool in brain studies. Zap a powerful magnet over a certain spot on the head - where motion is controlled - and someone's arm can suddenly, involuntarily, lash out. The question was how to harness that in a way that might improve disease. TMS also is being studied in stroke rehabilitation and other brain disorders. "The brain is an electrical organ," Dr. George said. "Electricity is the currency of the brain. It's how the brain does what it does." Patients in the NeuroStar study suffered no seizures or memory problems like shock therapy can cause. The chief complaint was headaches. The FDA cleared the device after focusing just on a subset of the patients initially enrolled - 164 who had failed one antidepressant during their current bout of depression, not those who were more severely treatment-resistant. About 24 percent who got TMS scored significantly better on standard depression measures after six weeks, compared with 12 percent who got the sham, says Dr. Janicak. Originally published by Associated Press. (c) 2008 Augusta Chronicle, The. Provided by ProQuest LLC. All rights Reserved.
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