IRB Number:

06-002192

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.
The purpose of this trial is to assess the safety and effectiveness of the RNS as an add-on therapy in reducing the frequency of seizures. Participants in the trial will continue to receive their epilepsy medications.

Who is Eligible to Participate in the Study?

Individuals who have been diagnosed with partial onset epilepsy (those that start from one or two areas of the brain) and have an average of three seizures per month that have not been controlled by taking two or more anti-epileptic medications may be eligible to participate in this study.

Minimum Age:

18

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.

After enrolling in the study, participants first complete the baseline period, which lasts a minimum of three months and a maximum of 15 months. During this part of the study, participants will keep track of their seizures in a diary on a daily basis. Study participants must have an average of three seizures for three consecutive months.

Once the eligibility criteria have been met, participants will be implanted with RNS. Study doctors will check on a participant's physical and emotional health and manage the RNS during regularly scheduled follow-up visits. Participants will continue to keep a daily seizure diary.

The RNS System Pivotal Investigation is a randomized, double-blind, sham stimulation controlled investigation. The double-blinded portion of the trial begins 28 days after the RNS is implanted and lasts about four months. Half of the participants will be randomly assigned (by chance) to have a responsive stimulation turned ON and half will have responsive stimulation turned OFF (sahm-stimulation). Participants and one doctor in the trial will not know whether stimulation is being delivered or not. Another doctor will program the RNS. Five months after the RNS has been implanted, when the double-blinded portion of the trial is completed, all participants will be able to have stimulation turned ON.

How long will the Study run?

Study participation is expected to last approximately two to three years.

Who can I Contact for Additional Information on this Trial?

Arizona - Joyce Dunshee 480-342-2189

Rochester - Karla Crockett 507-538-9140

Jacksonville - Karey Doll 904-953-2498

What is/are the Locations of this Clinical Trial?

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

Last updated: 05/06/2008