URMC Participates in Largest NIH Study of Epilepsy

$30 Million Grant Seeks Better, Early Treatment for Life-Altering Disease

March 01, 2004

"This study is not about surgery. It’s not about medication. It’s about finding a way to get the majority of patients with epilepsy seizure-free as soon as possible."

A study to compare the outcomes of the two forms of epilepsy treatment currently available—medications vs. brain surgery—to possibly cure the disease and improve a person’s quality of life is now underway across the nation.  The University of Rochester Medical Center and its Strong Epilepsy Center are one of 19 institutions participating in the $30 million Early Randomized Surgical Epilepsy Trial (ERSET). The largest epilepsy study ever undertaken, ERSET seeks to understand which treatment works best to try to eliminate seizures within the first two years of diagnosis for those patients who have not responded to standard epilepsy medications. The study will focus on mesial temporal lobe epilepsy (MTLE), the most common form of intractable epilepsy.

Even though more than 2.3 million Americans have epilepsy, little standardized research has been conducted to determine which treatment protocol produces the best results with the fewest side effects in the shortest time possible.  A motivating reason for this study is that epilepsy frequently affects children and young adults in the most critical years of their development, often leading to social isolation, poor school performance, and limited career options. 

Research has shown that while medications can eliminate seizures in about 65 percent of patients with epilepsy, those that do not respond tend to endure a prolonged period of time where physicians try different medication combinations, hoping to find one regimen that will work. Surgery is often considered a last resort. The latest study documented that patients live with epilepsy for an average of 17 years before seeking surgical treatment, even though about 70 percent remained free of disabling seizures after surgery.

“This study is not about surgery. It’s not about medication. It’s about finding a way to get the majority of patients with epilepsy seizure-free as soon as possible,” said Michel Berg, M.D., medical director of the Strong Epilepsy Center. “Because epilepsy tends to appear during the most critical development timeframe for children and young adults, it has a tremendous negative domino effect on the life that person will be able to lead. We need to find a better and quicker way to help these patients beat epilepsy so they can get back to being kids and young adults, and enjoy life.”

“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.”

When to Intervene?

Thirty percent of individuals with epilepsy have seizures that are intractable, meaning their seizures do not fully 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 estimated 100,000 eligible patients actually underwent epilepsy surgery despite the failure of multiple medication trials 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 demonstrate that surgery is superior to the medical treatment of long-standing MTLE.

ERSET is looking to enroll approximately 200 participants across the United States; URMC is hoping to enroll at least 13 study participants. Eligible participants must be at least 12 years old and have experienced seizures disruptive to their lives for less 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 and failed 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 randomly 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 Gerry Powers at 585-275-0589 or visit www.erset.net for information about the early treatment of MTLE and this clinical research study.

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.

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Germaine Reinhardt
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