New epilepsy treatment coming to West Michigan
One of the first health systems in the nation to offer treatment with a newly FDA-approved device that uses electric stimulation of the brain for adult epilepsy patients will be located in West Michigan.
The NeuroPace Responsive Neurostimulation System is an implantable device designed to detect abnormal electrical activity in the brain and respond by delivering imperceptible electrical stimulation to normalize brain activity before an individual experiences seizures.
Spectrum Health officials said the system is used on adult patients whose seizures have not responded to medication.
“For patients with frequent and disabling partial onset seizures who have proven unresponsive to two or more medications and who are not candidates for actual removal of abnormal tissue, this may prove to be a viable and welcome treatment option,” said Dr. Kost Elisevich, neurosurgeon, co-chair of the department of clinical neurosciences and chief of neurosurgery at Spectrum Health Medical Group.
The RNS System is designed for use in combination with other therapies in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures that originate and remain in a limited area of the brain. To be eligible for the procedure, patients must have frequent and disabling seizures (motor partial seizures, complex partial seizures and/or secondarily generalized seizures), whose origin is limited to two or fewer locations in the brain.
NeuroPace Inc., based in Mountain View, Calif., estimates that approximately 400,000 people in the U.S. meet these criteria and may benefit from treatment with the RNS System.
“Neurostimulation could provide relief from seizures for many patients who are not good candidates for surgery,” said Dr. Brien Smith, co-chair of the department of clinical neurosciences, chief of neurology at Spectrum Health Medical Group and immediate past chair of the National Epilepsy Foundation. “We plan to offer this treatment to eligible patients as soon as it becomes available.”
The U.S. Food and Drug Administration granted premarket approval for the RNS System on Nov. 14. While employed recently at Henry Ford Health System in Detroit, Elisevich and Smith were one of the first clinical teams in the nation to participate in clinical trials using the RNS System. The device has been evaluated for more than eight years in three clinical trials at 32 comprehensive epilepsy centers in the U.S.
The study demonstrated a nearly 38 percent reduction in seizure frequency in patients treated with responsive stimulation compared to an approximately 17 percent reduction in patients who were implanted with the device but were not receiving responsive stimulation during a three-month period. In a two-year follow-up phase, 55 percent of the subjects experienced a 50 percent or greater reduction in seizures.
Treatment with the RNS System will take place in Level 4 epilepsy centers throughout the nation following site qualification and physician training. Spectrum Health is the first epilepsy program in West Michigan to receive a Level 4 designation by the National Association of Epilepsy Centers. Level 4 centers have the professional expertise and facilities to provide the highest level of medical and surgical epilepsy evaluation and treatment for patients with epilepsy.