Multicenter clinical trial to evaluate epilepsy surgery
Jun 7, 2005 - 11:47:00 AM
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We now have very sophisticated means for identifying abnormal regions of activity in the brain, which has increased our ability to surgically treat epilepsy effectively,
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By University of Virginia,
[RxPG] Melinda Hillyard of Winchester , Va , first had epileptic seizures when she was eight years old. The seizures went away for years, then returned after the birth of her first child. I never knew when my world would turn upside down, she recalled. I was always independent and all of sudden that got taken away. Today, though, Hillyard is seizure-free after undergoing epilepsy surgery at the University of Virginia Health System in 2002. Its allowed me to have my life back, she said.
To see if Hillyards experience will benefit others, neurologists and neurosurgeons at UVa are participating in a multicenter clinical trial to evaluate whether epilepsy surgery is more effective than drugs to eliminate seizures in newly diagnosed patients. More than 2.3 million Americans have epilepsy, a rhythmic, electrical storm in the brain that brings on seizures, ranging from mild to severe depending on the location of the storm.
The study, called ERSET (Early Randomized Surgical Epilepsy Trial) is sponsored by the National Institutes of Health and will compare the ability of surgery and medications versus medications alone to eliminate seizures and side effects, improving the quality of life for epilepsy patients and rescuing some from a lifetime of disability. UVa doctors hope to recruit at least ten patients from the mid-Atlantic region. They must be diagnosed with temporal lobe epilepsy (where seizures originate in the temple above the ear) and have had at least six seizures a year for no longer than two years.
The clear benefit of this study is that if early surgery provides a better outcome than standard medication treatment, we will be encouraging all patients with early temporal lobe epilepsy to have surgery, said Dr. Nathan Fountain, associate professor of neurology and director of UVas F. E. Dreifuss Comprehensive Epilepsy Program, founded in 1977 as one of only three epilepsy programs funded by the NIH at the time. Most patients with epilepsy dont come in for a surgical evaluation until twenty years after their symptoms appear, which is a tragedy considering how safe epilepsy surgery is. Anyone who is still having seizures after trying two standard epilepsy drugs should be evaluated for surgery.
Fountain points out that the risk of stroke or death from epilepsy surgery is about one percent and the risk of annoying complications (such as headaches and depression) is 15 percent. However, the risk of dying from epilepsy without surgery over the course of a patients life is relatively high.
People who may undergo epilepsy surgery are first evaluated in UVas Epilepsy Monitoring Unit, where seizures are recorded during scalp video-electroencephalogram (EEG) monitoring. Sophisticated tests are done, including brain imagining with high-resolution MRI (magnetic resonance imaging) and PET (positron emission topography.)
Patients also undergo neuropsychological testing.
We now have very sophisticated means for identifying abnormal regions of activity in the brain, which has increased our ability to surgically treat epilepsy effectively, said Dr. Jeff Elias, assistant professor of neurosurgery and director of the Functional Neurosurgery Program at UVa.
During epilepsy surgery, neurosurgeons open the cranium and remove the part of the brain where the seizures are located. In a temporal lobectomy, the most common epilepsy procedure, about 4 centimeters of the temporal lobe are removed. We are removing a sick part of the brain that doesnt work right to begin with, Fountain said.
Fountain and his team at the Dreifuss epilepsy program are evaluating the safety and efficacy of six new epilepsy drugs, potentially the first drugs on the market in six years.
Fountains team is also leading trials at UVa evaluating two new epilepsy treatment devices. Deep brain stimulation with electricity holds the promise of controlling seizures. Similarly, a device surgically implanted in the brains cortex uses an electrical current to arrest seizures when they begin. Its clear that the modern goal of epilepsy treatment is to free patients from seizures without causing side effects, Fountain said.
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