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Medical center's epilepsy program
participating in pivotal clinical trial
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
“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 http://www.seizurestudy.com 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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