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Medical center's epilepsy program participating in pivotal clinical trial

by Maggie Diebolt
Public Relations
To discover more effective therapy and improve the lives of people with epilepsy, MUSC is participating in a study to evaluate the safety and effectiveness of a responsive brain stimulation device being tested to reduce the frequency of uncontrolled seizures.
The RNS System Pivotal clinical trial involves using an implantable device  designed to detect abnormal electrical activity in the brain of a person with epilepsy. In response to the abnormal activity, the device delivers small amounts of electrical stimulation to suppress an oncoming seizure. The device is surgically implanted in the skull beneath the scalp. Experience from earlier tests using the RNS system in 65 adults with epilepsy indicates that the device has a favorable safety profile.
“This is an exciting trial. The device not only reads EEG information directly from the brain of a person with epilepsy, it can also be taught to recognize an individual patient’s characteristic seizure pattern, and to deliver a stimulus to try to stop the seizure,” said Jonathan Edwards, M.D., MUSC epilepsy program director. “This may lead to a completely new way of treating seizures directly at the source.”
More than 3 million people in the United States, including an estimated 55,000 to 65,000 South Carolina residents, have epilepsy. Epilepsy is a medical condition in which an underlying tendency of the brain produces sudden bursts of electrical energy that disrupt other brain functions. This electrical surge results in seizures that can affect a variety of mental and physical functions.
While medications and other therapies developed in recent years have improved the health status and quality of life of those with epilepsy, approximately 30 percent to 40 percent of these individuals continue to suffer from seizures.
With epilepsy experts scattered across the state, access to specialized care can be difficult to find.
The only center in South Carolina recognized by the National Association of Epilepsy Centers, it also is the only program in the state participating in the RNS study. Notably, MUSC’s Comprehensive Epilepsy Program features a system for assessing mood disorders in patients, involves social workers and vocational rehabilitation specialists, five epileptologists, a neuroradiologist, and ongoing research programs and clinical trials.
MUSC features a level 4 Comprehensive Epilepsy Center, meeting or exceeding all guidelines set by the National Association of Epilepsy Centers for this highest category. Level 4 indicates extensive expertise and truly comprehensive care in the medical, social, psychological and surgical treatment of epilepsy.
Steven Glazier, M.D., chief of Neurosurgery and director of Pediatric Neurosurgery, is an accomplished epilepsy neurosurgeon. “This is the first device for the brain that reacts to the brain and delivers therapy when needed,” he said, “All other brain stimulators deliver treatment at a prescribed interval.”
People with epilepsy who experience uncontrolled seizures (those that occur three or more times a month) should visit or call 866-904-6630 to be evaluated to determine if they are a candidate for the RNS System Pivotal Clinical Investi-gation.
Final determination regarding eligibility for the clinical research study is made by the clinical research study staff.


Friday, Feb. 29, 2008
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