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AAN: Vagus Nerve Stimulation is Safe and Effective for Epilepsy Patients

ST. PAUL, MN -- Using an implanted device to treat epilepsy patients with partial seizures is safe and effective, according to an assessment conducted by the American Academy of Neurology, a professional association of more than 16,000 neurologists and related neuroscience professionals. The assessment was published in the September 11 issue of Neurology, the American Academy of Neurology's scientific journal.

The device electrically stimulates the left vagus nerve in the neck, which controls activity between the brain and major internal organs.

The assessment was based on a review of all clinical trials using the stimulator, including two large, randomized, controlled trials. Those trials involved a total of 310 patients who had at least six seizures a month and whose seizures were not responsive to medication. These study patients had an average of 25 to 30 percent fewer seizures than they did before, an improvement rate comparable to that of patients taking a new epilepsy drug, according to neurologist Adrian Handforth, MD, of the Veterans Administration of the Greater Los Angeles Health Care System, who is co-author of the assessment.

"The good news is that this is an entirely new kind of therapy that avoids the side effects that accompany epilepsy medications," Handforth said. "Most patients don't become seizure-free, but more than half of patients say their quality of life has improved, because either the number of seizures or the intensity of seizures has gone down."

The assessment evaluated which patients are candidates for the nerve stimulator:

* The device is appropriate for people who are unable to tolerate or benefit from the use of epilepsy drugs.

* Patients should be evaluated to determine whether they are candidates for surgery that can potentially cure their epilepsy before considering the vagus nerve stimulator.

To develop the assessment, the American Academy of Neurology reviewed the scientific evidence available from all clinical studies using the vagus nerve stimulator. The AAN published an assessment of vagus nerve stimulation in 1997 concluding that it was promising but not yet established. The current assessment was initiated when additional evidence became available from a second large, randomized, controlled clinical trial.

The stimulator is implanted in a patient's chest with small wires leading to the vagus nerve; it does not interfere with patients' daily activities. The device is programmed to send electrical impulses to the nerve as often as for 30 seconds at five-minute intervals 24 hours per day; the timing can be adjusted for individual patients' needs. The main side effect experienced by patients is hoarseness or throat discomfort during the stimulation.

Epilepsy is classified into two major categories: partial and generalized. Partial seizures involve abnormal electrical activity in one area of the brain; generalized seizures involve abnormal activity in the entire brain.

The American Academy of Neurology is dedicated to improving patient care through education and research.

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