ERSET, which is sponsored by the National Institute of Neurological Disorders and Stroke, a part of the National Institutes of Health within the U.S. Department of Health and Human Services, offers an opportunity for eligible participants and their families to learn about early treatment for mesial temporal lobe epilepsy (MTLE), the most common form of epilepsy. ERSET will also provide eligible participants with care and attention at leading epilepsy centers in the United States.
Research shows that MTLE may be progressive in nature, especially in children. As seizures continue, they can cause irreversible disturbances in nerve cell function, preventing normal brain development. "Data suggests that seizures can cause memory loss and affect a child's ability to learn and pay attention in school," said Dr. Jerome Engel Jr., professor of neurology at the David Geffen School of Medicine at UCLA and the principal investigator for ERSET. "Persistence of seizures during adolescence and early adulthood commonly cause irreversible social and psychological consequences."
"This is an important study and we expect that it will answer key questions about treatment choices and the timing of surgical treatment when seizures are difficult to control," said Eric R. Hargis, president and CEO of the Epilepsy Foundation. "Deciding when or whether to continue treatment with medications or to have surgery can be difficult and stressful for people with epilepsy and their families. The results of this study will, we hope, make those decisions easier and in the long run will improve quality of life for hundreds of thousands of patients."
Thirty percent of individuals with epilepsy have seizures that are intractable, meaning their seizures do not respond to medications. MTLE is often found to be intractable, and seizure intractability may be predicted with a high degree of confidence after two antiepileptic medications have proven ineffective. There are more than 20 antiepileptic medications, and specific therapies often depend on a patient's seizure type and how long they have been having seizures.
Many clinicians remain uncertain about the cost, safety and success rates of surgery and consider it a last resort. The most current data available, which is from 1990, shows that only 2,000 of the 100,000 eligible patients actually underwent the procedure despite the failure of medications to control their seizures. Surgery for MTLE involves the removal of a small amount of brain tissue that is the source of a person's seizures. There have been medical reports, including one published in the August 2, 2001, issue of The New England Journal of Medicine, that purport that surgery is superior to the medical treatment of long-standing MTLE.
ERSET is looking to enroll approximately 200 participants across the United States. Eligible participants must be at least 12 years old and must also have experienced seizures disruptive to their lives for not more than two years. If they experienced seizures earlier in life that stopped and subsequently reemerged, they may still be eligible for this clinical research study. In addition, participants must have tried at least two different antiepileptic medications.
ERSET participants will have a complete evaluation to determine if they are eligible for the research study. If determined eligible, participants are assigned to treatment by surgery with medication or by medication only, and all will receive antiepileptic medications based on the best possible plan designed by epilepsy experts. After two years of follow-up, eligible participants who received medication only will have the option to undergo surgery. Those interested can call 310-267-2880 or visit http://www.erset.net for information about the early treatment of MTLE and this clinical research study.