Epilepsy experts at the Indiana University School of Medicine are joining colleagues around the country to determine whether medications or early surgery works best to treat and eliminate seizures.
Researchers at 18 sites are seeking patients to participate in the Early Randomized Surgical Epilepsy Trial, a five-year, $30 million study sponsored by the National Institute of Neurological Disorders of the National Institutes of Health.
People with mesial temporal lobe epilepsy, the most prevalent form of the disorder, may be eligible for the trial. The malady can cause disturbances in brain function creating auras of fear, anxiety, nausea, odors, jerking, and difficulty in walking, moving or speaking.
"This study is comparing the safety and effectiveness of FDA-approved drugs with the safety and effectiveness of a surgical procedure in combination with FDA-approved drugs," says Vicenta Salanova, M.D., IU trial site director.
For most, seizures can be controlled with just one medication; however, combined medications can exacerbate fatigue, changes in appetite and mental concentration. However, more than 30 percent of patients cannot control seizures with drugs.
"Surgery remains an option," says Dr. Salanova. "As many as 200,000 or more patients are potential candidates for surgery in the United States, but only 3,000 procedures are performed annually."
Surgical removal of seizure-causing areas in the mesial temporal lobe is successful in as many as 80 percent of the patients. This type of surgery has been used for many years.
To be considered for the trial, patients must:
-- Have disabling seizures six days per year or more for no more than two consecutive years since the onset, or after remission of six months or longer
-- Have tried at least two antiepileptic drugs
-- Be 12 years of age or older with a history of temporal lobe epilepsy
Patients accepted into the ERSET trial are randomly accepted to receive either medications or undergo surgery. The process ensures participants have an equal chance to receive either therapy.
The follow-up period for patients in the study is two years. Those selected for the medication-only part of the study can choose to have surgery at that time.
Patients receive exams four times a year at Indiana University Hospital where their progress is monitored.
More than 2.3 million Americans are diagnosed with epilepsy and it often affects children and young adults during the critical years of their development.
"Ideally, this study will help make treatment decisions easier and improve the quality of life for those with epilepsy," says Dr. Salanova.
The principal investigator of the ERSET study is Jerome Engel Jr., M.D., Ph.D., of the David Geffen School of Medicine at the University of California-Los Angeles.
To enroll or learn more about the trial at IU, call 317-274-4974. Additional information about ERSET can be found at http://www.erset.net.