Contact: Jean A. Spinelli or George Humphrey, (520) 626-7301
Nov. 2, 1995

A new option in the treatment of epilepsy -- an implantible device similar to a pacemaker that prevents epileptic seizures -- is being investigated by the Department of Neurology at The University of Arizona College of Medicine in Tucson.

The UA is one of only two institutions in the Southwest participating in a nationwide study of the device, called the NeuroCybernetic Prosthesis (NCP®) System, which has been approved by the U.S. Food and Drug Administration for a seven-month clini cal trial in more than 200 patients. The UA expects to begin implanting the device in study participants by the end of this month. The NCP® device delivers automatic, intermittent electrical stimulation to the vagus nerve, which is connected to areas of the brain thought to be involved in producing epileptic seizures. "Initial clinical studies have been positive," says David Labiner, M.D., assistant professor of neurology and director of the Arizona Comprehensive Epilepsy Program at the UA Colle ge of Medicine. "This study, which will evaluate stimulation believed to be the most effective, is pivotal in the development of the device as another option in the treatment of epilepsy."

The NCP® System, developed by Cyberonics Inc., consists of a battery-powered generator, about the size of a large pocket watch, that is attached by a lead to the left vagus nerve. The generator and lead are implanted in the upper left chest in a one- to two-hour surgical procedure under general anesthesia. The battery is expected to last three to five years. The generator periodically stimulates the vagus nerve 24 hours a day, whether or not the patient experiences a seizure. The stimulation is nearly imperceptible by the patient.

The intensity, duration and frequency of the stimulation can be adjusted by the patient's physician with a hand-held programmer during monthly follow-up visits. Patients who experience an aura (warning sensation) prior to a seizure can activate the gener ator with a magnet to send a stimulation burst that may stop or lessen the impending seizure. A family member or friend also can activate the generator with the magnet if they observe a seizure. The device is not affected by microwaves or airport securi ty systems.

Nearly 1 percent of the U.S. population is affected by epilepsy, a neurological condition characterized by recurrent seizures or temporary alteration in brain function, sometimes resulting in loss of consciousness. Seizures may result from a variety of d iseases or injuries, including head injuries, brain infections, brain tumors or stroke, or there may be an inherited predisposition. The only treatments currently available are drug therapy, which may not always be effective and can have severe side-effe cts, and, in rare cases, brain surgery. Research for alternative therapies suggests that stimulation of the vagus nerve may disrupt the abnormal electrical activity in the brain that causes seizures.

PLEASE NOTE: The UA study is recruiting participants from Arizona, New Mexico, Colorado and Utah. Men and women, ages 12-65, who have an established diagnosis of epilepsy that is not well-controlled with medications and who are not candidates for brain surgery, may be eligible to participate. For more information, patients should contact David Labiner, M.D., the UA study's principal investigator, (520) 626-4551.