NeuroPace RNS Clinical Trial for the Treatment of Epilepsy
California Pacific Medical Center is one of only a handful of hospitals in the United States participating in the NeuroPace Responsive Neurostimulator (RNS) System Pivotal clinical trial. This is an FDA approved, multi-center, pivotal clinical trial of a responsive brain neurostimulator for the treatment of epilepsy. The investigation is designed to assess the safety and effectiveness of the RNS in reducing the frequency of medically uncontrolled and disabling partial onset seizures. Nationwide, as many as, 30% of epilepsy patients continue to have uncontrolled seizures, despite the best medical efforts and some patients are not candidates for surgery or have side effects from antiseizure medication. Brain devices to treat epilepsy may offer hope to these persons.
How does the RNS System Work?
The RNS system is surgically implanted under the scalp and connected to one or two leads (insulated wires with four (4) small electrodes at the end). These leads are implanted within the patient’s brain and/or placed on the brain surface, in the area of the presumed seizure origin. The RNS continuously monitors the patient’s brain waves. When seizure activity is detected, the device delivers brief and mild electrical stimulation through the leads in an attempt to suppress seizures.
Participants
This study is now closed. Study participants were between 18 to 70 years old and had an average of three seizures for three consecutive months to be eligible for implantation of the RNS. Once eligibility criteria are met, participants were implanted with the RNS. We continue to check on participant's physical and emotional health and manage the RNS during regularly scheduled follow-up visits.
I would like to learn more
If you are interested in this study please contact the California Pacific Medical Center Epilepsy Center at 415-600-7880.
Please send me more information on the Epilepsy Program at California Pacific Medical Center.
