IRB Number:

1021-04

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

Researchers at Mayo Clinic are looking at a new procedure that involves surgically placing a Responsive Neurostimulator (RNS) in the brain that may be able to suppress seizures in patients with epilepsy. This neurostimulator, thought of as a pacemaker for the brain, would be implanted in patients with epilepsy who have not responded to current treatment.

Who is Eligible to Participate in the Study?

You qualify as a participant because you have epilepsy, and have had at least four seizures per month while participating in a prior study (the Prospective Seizure Frequency clinical investigation), your seizures have not been effectively controlled by antiseizure medication or you do not tolerate antiseizure medication, and you have undergone a testing to determine the area of your brain where your seizures start.

What is Involved With this Study?

The self-contained device, not much bigger than a watch, is implanted by neurosurgeons under the scalp and is connected to one or two wires placed in the brain. The neurostimulator constantly monitors the brain’s electrical activity from these wires 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 any symptoms.

Qualified participants are now being enrolled in a preliminary study, for a minimum of three months during which time a seizure diary is maintained and they see a study doctor each month. Once 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 a total of two years. During this time, the seizure type and frequency are assessed on a monthly basis, and the physical and emotional health is assessed at various intervals.

How long will the Study run?

Participants will be enrolled in this research study for up to two years.

Who can I Contact for Additional Information on this Trial?

For more information or to participate in this research study, please contact Karla at (507) 538-9140.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL
• Scottsdale and Phoenix, AZ

Last updated: 10/11/2005