IRB Number:

1520-02

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This research study is being done to learn about the effects (both good and bad) of a brain stimulating device known as the External Responsive Neurostimulating System. This is an investigational device that was designed to detect seizure activity and give an electrical stimulation to the brain to try to stop it. Research has been done which suggests that electrical stimulation given at the time of an induced seizure can stop the seizure. In this study, a computer is used that will copy the function of the actual stimulator under development.

Who is Eligible to Participate in the Study?

This research study is open to all men and women of all races undergoing monitoring with implanted electrodes
who are 18 and older.

What is Involved With this Study?

You qualify because you are being evaluated for epilepsy surgery with implanted electrodes. During your evaluation, your regular medications will be lowered or even stopped so that your doctors can record your seizures.

Your seizure monitoring and evaluation for surgery will not be affected by this study. Your monitoring and decisions about epilepsy surgery will be the same whether or not you take part in this research study.

How long will the Study run?

The study begins after your doctors have recorded enough seizures to make final decisions about your surgery. It ends when your surgeon takes you to surgery to remove
the electrodes. This period of time varies from 1-5 days depending on the surgeon's schedule. The fact that you are participating in this study will not increase the time between the end of seizure monitoring and surgery.

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
• Scottsdale and Phoenix, AZ

Last updated: 10/11/2005