Neurostimulator device company NeuroPace, Inc. is pointing us at interim results from its ongoing long-term treatment (LTT) study, which it says demonstrate the RNS® System significantly reduces seizure frequency among adults who have a common form of epilepsy that is difficult to treat with medication.
Neurostimulation has many guises and many proposed functions, including pain management, dystonia and epilepsy to name a few.
NeuroPace says its RNS System is the first closed-loop responsive brain stimulation system. It is designed to treat partial onset seizures by detecting specific types of electrical activity in the brain through leads containing electrodes that are placed near the patient’s seizure focus or foci. When detection thresholds are met, the device delivers small bursts of electrical stimulation intended to reduce the frequency of seizures. Importantly, physicians can program the detection and stimulation parameters of the implanted RNS Neurostimulator non-invasively to customize therapy for each individual.
The system received U.S. FDA premarket approval (PMA) in November 2013 and is approved as a treatment for adults with partial onset seizures with one or two seizure onset zones whose seizures have not been controlled with two or more antiepileptic drugs.
The ongoing LTT study has yielded results that have recently been published in Neurology, include data on 230 people with medically intractable partial onset epilepsy enrolled at 33 Comprehensive Epilepsy Centers in the United States.
The LTT study is an ongoing seven-year, multi-center prospective open-label study for participants who previously completed a feasibility or randomized controlled trial of the RNS System. 97 percent of these patients elected to continue treatment and participate in the LTT study.
The median reduction in seizure frequency in the pivotal study was 44 percent at one year and 53 percent at two years, and ranged up to 66 percent over post-implant years three through six in the LTT study. Furthermore, 23 percent of patients experienced at least one six month period free of seizures. For comparison, these patients had to average at least three seizures per month in order to enroll in the original trial. The study also demonstrated significant improvements in overall quality of life and indicates a more positive perception of cognitive function, relationships and social function, overall health, and vulnerability to seizures. There were no serious unanticipated device related adverse events in the trial and responsive neurostimulation was well-tolerated and safe over time.
“The interim study results, which covered 1,293 patient stimulation years, confirm our belief that the therapeutic benefits of the RNS System are not only sustained, but actually increase over time for many people,” said Martha Morrell, MD, Chief Medical Officer of NeuroPace, Inc. and Clinical Professor of Neurology at Stanford University. “Beyond the sustained seizure frequency reduction, patients in this study gained significant improvements in quality of life in areas such as memory, language, attention, and overall health. This patient population has been unable to find relief with other treatments, and we are extremely hopeful that the RNS System can help hundreds of thousands of adults in the U.S. with refractory partial seizures in the future.”
Source: Business Wire