FDA-Approved Brain Stimulator Shown to Reduce 'Untreatable' Epileptic Seizures
DETROIT, Nov. 20, 2013 /PRNewswire/ -- Because of its participation in a pivotal trial, Henry Ford Hospital will be the first in Michigan to offer electric stimulation of the brain using a newly FDA-approved device for hard-to-treat epilepsy cases.
Called the NeuroPace Responsive Neurostimulation (RNS) System, the device has been shown to provide significant relief to the thousands of epilepsy patients with intractable seizures for whom drugs and other treatments have not worked.
"For the third of people who have tried two or three medications for their epilepsy, but are still having seizures, the standard of care is removing the abnormal part of the brain that is causing seizures," says Jason M. Schwalb, M.D., Surgical Director of the Movement Disorder and Comprehensive Epilepsy Centers at Henry Ford Health System.
"More than 50 percent of patients undergoing surgical removal of brain tissue causing seizures will be cured of their epilepsy. However, there are people who are not candidates for this type of surgery because of potential side effects. Until now, we have not had great treatment options. The RNS system is an attractive option for these patients, especially since it is reversible."
The RNS System consists of a miniaturized, implanted computer which can detect seizures from electrodes implanted in or on the surface of the brain and deliver an electrical pulse to stop them.
The RNS System has demonstrated safety and effectiveness in patients who average three or more disabling seizures per month over the three most recent months (with no fewer than two seizures a month). It has not been evaluated in patients with less-frequent seizures.
It is estimated that approximately 400,000 people in the U.S. meet these criteria and may benefit from treatment with the RNS System.
The RNS System has been evaluated in three clinical trials, including a prospective, randomized, double-blind and sham stimulation-controlled pivotal study. The pivotal study primary effectiveness endpoint was met by demonstrating a 37.9 percent reduction in seizure frequency in patients treated with responsive stimulation, compared to a 17.3 percent reduction in patients who were implanted with the device but were not receiving responsive stimulation during a three-month blinded period.
The Henry Ford Comprehensive Epilepsy Center is recognized by the National Associations of Epilepsy Centers as a Level 4 epilepsy center. Such centers provide the more complex forms of intensive neurodiagnostics monitoring, as well as more extensive medical, neuropsychological, and psychosocial treatment. Fourth-level centers also offer a complete evaluation for epilepsy, surgery, (including intracranial electrodes), and provide a broad range of surgical procedures for epilepsy.
The Center has one of the largest programs in the country, conducting more than 4,000 clinic appointments, 3,000 EEGs, 300 admissions for monitoring and more than 30 surgical procedures annually. It includes epilepsy monitoring units at two hospitals and eight epileptologists.
For information on RNS stimulation and treatment of epilepsy, call the Henry Ford Comprehensive Epilepsy Center hotline at 313-916-3922.
SOURCE Henry Ford Health System