DISEASE BACKGROUND: It's estimated that one percent of the American population has epilepsy. For 20 percent of these patients, the seizures, known as medically refractory seizures, are not controllable by medication. With these cases, the only option has been brain surgery and only if doctors could pinpoint the area of the brain that was causing the seizures. Now, researchers are treating patients in a noninvasive way using beams of gamma radiation.
RESEARCH: The purpose of the clinical trial is to see if radiosurgical treatment will result in a significant reduction in seizure numbers in patients with medically refractory mesial temporal lobe epilepsy. The study will use two different doses of radiation with patients randomized into either a low- or high-dose group.
Researchers believe both radiation doses will be successful in eliminating seizures in more than half of the patients. Patients will undergo a number of preliminary tests including an MRI for doctors to pinpoint the area to focus on in the brain. Patients will then be treated in a hospital and will spend one night for observation.
The effects of the radiation may take several weeks to a few months to begin. The final outcome may not be known for as long as 18 months. The main risk with the procedure is necrosis, or swelling of the brain, which can cause headaches and other side effects.
PREVIOUS STUDIES: What makes this new treatment so effective is that advanced technology allows doctors to precisely target 201 beams of radiation at one specific area. This allows a small area to be treated with high doses and without warming other areas of the brain.
Radiation has been shown to reduce seizures in animal models. However, only a small number of animals have become completely free of seizures, but the follow up time has been relatively short. As for humans, patients with seizures associated with brain tumors often show improvement in the number of seizures they experience after radiation treatment. Additionally, a multi-center European trial is in progress with excellent seizure reduction. In that study, 20 patients were treated with radiation and 18 patients report being seizure-free 15 months after treatment. The study is still ongoing.
CURRENT STUDY CITIES:
FOR MORE INFORMATION, PLEASE CONTACT:
Indiana University School of Medicine
535 Barnhill Drive, RT-041
Indianapolis, IN 46202-5289