Rhode Island news
Most in study showed progress
01:00 AM EST on Sunday, December 17, 2006
Mario Della Grotta was one of several people who participated in a small, pilot study of deep brain stimulation as a treatment for obsessive-compulsive disorder. Most of the other patients also improved and suffered few side effects.
But more research is needed, on many more people, to know whether this is a worthwhile therapy.
In the months after Della Grottas operation in February 2001, four additional patients had electrodes implanted in their brains at Rhode Island Hospital, and five patients underwent the procedure at the Cleveland Clinic. (Five patients at University of Florida in Gainesville also had the procedure, but the results have not yet been published.)
Among the 10 patients in Providence and Cleveland, the youngest was a 22-year-old man who had suffered from OCD since age 8; the oldest was a 59-year-old woman who had endured the illness for 40 years. At the start of the study, not one was working, attending school, or even able to live independently, according to a report published in June in the journal .
Three years later, two patients had stopped the stimulation because they didnt see enough improvement. One patient died of breast cancer.
Of the remaining seven, two were working full-time, one (Della Grotta) had earned a college degree, and another had started technical training. Four were able to live independently. Social engagement improved as well: two were dating and one planned to marry. All reported that their symptoms had improved.
As with any medical intervention, bad things happened, too. But none was devastating or lasting, according to the reports lead author, Dr. Benjamin D. Greenberg, of Butler Hospital and Brown Medical School. Della Grotta suffered a superficial infection near where the wire emerged from his skull. One patient had a seizure during surgery, another had a small hemorrhage that caused no damage. Some initially had troublesome reactions to the stimulation, such as insomnia, memory flashbacks, or panic, until the doctor found the right settings.
The research was financed by the National Alliance for Research on Schizophrenia and Depression, the National Institute of Mental Health, and Medtronic, the implant manufacturer. Greenberg says he does not receive consulting fees from Medtronic nor does he own stock in the company.
A few months after the study results were published, Butler Hospital, along with the Cleveland Clinic, the University of Florida at Gainesville, and Massachusetts General Hospital, won a $5-million grant from the National Institute of Mental Health to conduct further research into using deep brain stimulation to treat OCD.
The new study, enrolling 30 people, will continue to test the effectiveness of deep brain stimulation, but will also try to determine who is most likely to benefit from it -- based on brain images taken before the surgery as well as personality traits. The researchers also aim to better understand what goes on in the brain when OCD occurs and when stimulation is applied. Pictures of the brain will be taken before the surgery, and then while the implant is activated and while it is turned off.
Greenberg estimates that about 50 people worldwide have had deep brain stimulation for OCD, most -- but not all -- through legitimate clinical trials in the United States and Europe. He and others are also studying the procedure as a treatment for depression.
The implants manufacturer, Medtronic, has applied to the Food and Drug Administration for a humanitarian use exemption that would allow deep brain stimulation to treat OCD at medical centers that follow a research protocol. Such approval could lead to insurance coverage for the operation, which costs in the range of $40,000 to $50,000, including the device.
Although enthusiastic about the potential of deep brain stimulation, Greenberg and study coauthor Steven A. Rasmussen fear that the procedure will be offered by doctors who lack the psychiatric training to select appropriate patients and who wont continue to care for the patients over the years.
We have already seen surgeons who have operated on people we dont think have OCD, Rasmussen says. You go on the Net, you find these people saying, Got psychiatric condition? We have the electrode. The world is somewhat unregulated.
-- Felice J. Freyer
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