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FDA approves therapy that beams impulses into the human brain
By Lauran Neergaard
Associated Press
Published on Tuesday, Oct 21, 2008
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 woodpeckerlike pulses trigger small electrical charges that spark brain cells to fire. Yet the treatment doesn't come with 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.
''We're opening up a whole new area of medicine,'' said 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.''
While there's a big need for innovative approaches — at least one in five depression patients resists treatment — 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.
For a clearer answer, the National Institutes of Health has a study under way that tracks 260 patients and may have initial results next year.
Quantifying the benefit is key, considering the price tag. TMS is expected to cost $6,000 to $10,000, depending on how many treatments a patient needs, said 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 of dollars cheaper than invasive procedures.
TMS used in research
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. Beyond the ''wow'' factor, magnetized pulses were triggering brain activity.
The question was how to harness that activity in a way that might improve disease. TMS also is being studied in stroke rehabilitation and other brain disorders.
''Nobody thought this would work; it was a crazy idea. I had to do it at 6 in the morning before the real scientists came in,'' South Carolina's George laughed as he recalled the work he began in 1993.
But, ''the brain is an electrical organ,'' George added, explaining the rationale. ''Electricity is the currency of the brain. It's how the brain does what it does.''
For depression, psychiatrists aim the magnet at the left front of the head, the prefrontal cortex. The NeuroStar beams about 3,000 pulses a minute during a 40-minute treatment, done about five times a week for up to six weeks.
The theory: Stimulating brain cells in the prefrontal cortex triggers a chain reaction that stimulates deeper brain regions involved with mood.
WASHINGTON: The government has approved the first noninvasive brain stimulator to treat depression — a device that beams magnetic pulses through the skull.
Get the full article here.
Comments
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Posted 09:27 AM, 10/22/2008
While I tend to look askance upon "magnetic" claims of this sort, I'm always willing to be shown... It just might be so, and I appreciate the fact that it will be looked into more thoroughly by the NIH. I hope the results of the investigation will be positive; this medical problem really needs to be solved.
