Mayo Clinic to Examine Neurostimulator in Patients with Epilepsy

Friday, May 21, 2004

ROCHESTER, Minn. — Researchers at Mayo Clinic are enrolling participants in a clinical trial to determine if a responsive neurotransmitter (RNS) surgically implanted in the brain can suppress seizures in patients who have epilepsy. Cardiac pacemakers were once thought of as novelties and medical miracles, but today they are commonplace and are regulating thousands of heartbeats around the world. This neurostimulator, a pacemaker for the brain, can be implanted in epilepsy patients who have not responded to treatment.

Epilepsy is a chronic disorder of the brain that causes recurrent seizures and affects nearly three million people in the United States. Antiepileptic medication can leave most patients free from seizures or lessen their frequency and intensity. Those who do not respond to medications may be candidates for surgerical removal of the brain tissue responsible for triggering the seizure. In most cases, these patients still require medication to control seizures. The neurostimulator would eliminate the need to remove brain tissue from these patients.

The self-contained device, not much bigger than a watch, is implanted by neurosurgeons under the scalp and is connected to wires placed in the brain. The neurostimulator constantly monitors the brainÕs electrical activity for onset of seizure activity. When seizure activity is detected, the neurostimulator delivers mild electrical stimulation through the wires in an attempt to stop the seizure before the patient experiences symptoms.

Qualified participants are being enrolled in a preliminary study for a minimum of three months. Participants keep a seizure diary and see a study physician each month. If the participant meets the seizure frequency criteria of four seizures per month for three consecutive months, he or she is eligible to receive the implanted neurostimulator. After the device is implanted, participants are followed for two years. Seizure type and frequency are assessed monthly, and physical and emotional health will be assessed regularly.

Mayo Clinic is one of 13 U.S. medical centers conducting this clinical trial. The first implant of this device in a Mayo patient is scheduled for June. Those interested in obtaining more information or participating should consult their physician or the research study coordinator at 507-284-1588.

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Contact:
Richard Hurt, Jr.
507-266-2166 (days)
507-284-2511 (evenings)
e-mail: newsbureau@mayo.edu

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