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Medication Versus Surgery Evaluated in Epilepsy Study

SEATTLE, Sept. 25 /PRNewswire/ -- More than 2.3 million Americans have epilepsy, and it frequently affects children and young adults in the most critical years of their development. Medication is the most common treatment option, and surgery is often considered a last resort. Now a clinical research study, titled the Early Randomized Surgical Epilepsy Trial (ERSET), is evaluating two standard therapies provided by epilepsy specialists -- treatment with medications and treatment with surgery -- to compare the ability of each to eliminate seizures and side effects as soon as possible, and to improve quality of life.

ERSET, which is sponsored by the National Institute of Neurological Disorders and Stroke, a part of the National Institutes of Health (NIH) 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 at epilepsy centers in the United States, including Swedish Medical Center. One of 18 sites participating, Swedish is the only center west of Minnesota and north of San Francisco.

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 David Vossler, M.D., Swedish Medical Center neurologist and the hospital's co-principal investigator on 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 Aug. 2, 2001, issue of The New England Journal of Medicine, that purport surgery is superior to the medical treatment of long-standing MTLE. Potential risks associated with surgery include memory impairment, infection and bleeding.

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 life-disrupting seizures for no more than two years. If they experienced seizures earlier in life that stopped and subsequently re- emerged, 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.

To learn more about ERSET, participation and who may be eligible, call 1-800-352-9424 or visit www.erset.net for information about the early treatment of MTLE and this clinical research study.

ERSET Fact Sheet

* The Early Randomized Surgical Epilepsy Trial (ERSET) is a multicenter, NIH-sponsored clinical research study that is evaluating two standard therapies provided by epilepsy specialists -- treatment with medications and treatment with surgery -- to compare the ability of each to eliminate seizures and side effects as soon as possible, and to improve quality of life.

* ERSET 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.

* Eligible participants will receive care from participating epileptologists and centers in the United States. The goal of the study is to enroll 200 participants.

* Individuals 12 and older with suspected mesial temporal lobe epilepsy (MTLE) may be eligible for the research study if their seizures 1) have not responded to two or more antiepileptic medications; and 2) have been disruptive to their lives for no more than two years. If they experienced seizures earlier in life that stopped and subsequently re-emerged, they may still be eligible for this clinical research study.

* If individuals do not think they have epilepsy, but have seizures or a seizure disorder, they may still qualify for this research study.

* To determine eligibility, participants will receive a complete evaluation, which will include magnetic resonance imaging (MRI), positron emission tomography (PET) scans of the brain, inpatient video electroencephalography (EEG) telemetry, and neurocognitive evaluations.

* Eligible participants will be randomly assigned to receive surgery and medication, or medication only. They are asked to make 11 visits to the clinical research site over the course of two years.

* Eligible participants who only receive antiepileptic medication will have the opportunity to be considered for surgery at the completion of the two-year follow-up period of the study.

* ERSET will cover the epilepsy medical costs of eligible participants that exceed or are not covered by insurance. This period begins with the first site appointment to determine eligibility and continues through the end of treatment. It also includes the option of surgery after the two-year follow-up period for eligible participants who receive medication only. Costs not covered by the study include transportation and parking necessary for travel to the research site, food or lodging required during visits to the site, or medical costs not related to eligible participants' epilepsy.

* The New England Journal of Medicine published results of a study in the Aug. 2, 2001, issue that were the basis for ERSET. Between July 1996 and August 2000, Dr. Samuel Wiebe at the University of Western Ontario led a clinical research study, which demonstrated the effectiveness of surgery for patients with long-standing intractable seizures associated with MTLE.

* To learn more about ERSET, participation and who may be eligible, people can call 1-800-352-9424 or visit www.erset.net for information about the early treatment of MTLE and this clinical research study.

Source: Swedish Medical Center

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