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by Jill Coley
Of The Post and Courier
FDA clears treatment for depression

One in 20 people suffers from depression. Half of those have an intractable type that will not respond to medicine or talking therapy.
 
Dr. Mark George, psychiatry professor and director of the Brain Magnetic Stimulation Laboratory at MUSC, has worked for more than a decade developing a new therapy to help depressed patients who are running out of options.
 
The NeuroStar Transcranial Magnetic Stimulation Therapy system was developed by Malvern, Pa.-based Neuronetics with research that began at MUSC. The Food and Drug Administration cleared the device Tuesday for marketing.
 
The device basically is a powerful magnet that delivers focused pulses to an area of the brain that is linked to depression. The magnetic pulses stimulate the nerve cells, and through a process not fully understood, the stimulation alleviates symptoms of depression.
 
It is the first clearance for the marketing of a transcranial magnetic stimulation system for treatment of major depressive disorder, FDA press officer Scott McFarland said.
 
Previously, the arsenal to help treatment-resistant patients comprised different methods of sending electricity into the brain.
 
Although several methods exist today, the oldest form is electroconvulsive therapy, known as ECT or “shock therapy,” which has a stigma because of its early use without anaesthesia.
 
In ECT, electrical currents are sent through the brain and trigger a brief seizure. No one knows exactly how the therapy works, only that changes seem to occur in the brain’s chemistry in a way that can offer relief for some mental illnesses.
 
George, a brain imaging expert, said, “I became convinced the  seizure  didn't matter. The electricity or current to the brain is what matters. Maybe we can just kind of tickle those circuits without turning them off.”
 
Early trials on the technology were carried out with funding from NARSAD, an international charity dedicated to mental health research. The most recent trial was funded by the device manufacturer, and MUSC is conducting another study sponsored by the National Institute of Mental Health.
 
This gentler approach has fewer side effects than electroconvulsive therapy and takes less time, George said. No anaesthesia is required and no adverse effects on concentration or memory were reported.
 
“It feels like hitting your head with a hard eraser,” he said.
 
A course of treatment will cost about $6,000, compared to electroconvulsive treatments which can run up to $20,000. “The next big question is will insurance pay for these,” George said.
 
The machine costs between $50,000 and $60,000, George said. The manufacturers have made only 15. MUSC will lease a device and begin treatments in about two months, he said.
 
Charleston psychiatrist James C. Ballenger recommended a handful of his patients to participate in the manufacturer’s trial and described the therapy as “close to being miraculous.”
 
Unlike other forms of brain stimulation treatments, Ballenger said, “The average psychiatrist can have this in his office.”
 
One of his patients had been depressed for 20 years and tried every available medication with only short-term success. “He had an astoundingly positive response,” Ballenger said.
 
In rare instances, the treatment can make changes in a patient’s psychology that are unwanted, he said. For example, a bipolar patient may swing from depression to mania.

Clinical trial
To learn more about enrolling in a current National Institute of Mental Health study on transcranial magnetic stimulation for treatment-resistant clinical depression, go to http://tinyurl.com/3wykwd.

Editor’s note: The article ran Oct. 13 in the Post and Courier and is reprinted with permission.


Friday, Oct. 17, 2008



The Catalyst Online is published weekly by the MUSC Office of Public Relations for the faculty, employees and students of the Medical University of South Carolina. The Catalyst Online editor, Kim Draughn, can be reached at 792-4107 or by email, catalyst@musc.edu. Editorial copy can be submitted to The Catalyst Online and to The Catalyst in print by fax, 792-6723, or by email to catalyst@musc.edu. To place an ad in The Catalyst hardcopy, call Island Publications at 849-1778, ext. 201.