The largest and longest prospective neuromodulation trial in the field of epilepsy showed about a 75% response rate with patients achieving at least a 50% reduction in seizures.
Dileep Nair, MD
NeuroPace has announced the final and complete results from its Long-Term Treatment study of its Next-Gen responsive neurostimulation (RNS) system, which showed positive results for patients with drug-resistant epilepsy.1
The 9-year follow-up data showed about a 75% response rate with patients achieving at least a 50% reduction in seizures. Additionally, approximately 33% of patients achieved at least a 90% reduction in seizures. The findings were presented at the American Epilepsy Society’s 72nd annual meeting in New Orleans, Louisiana, at NeuroPace’s booth.
Patients also reported improvements in quality of life, including memory and cognition—2 facets of epilepsy which result in the most common complaints from patients, Kate Davis, MD, MSTR, an epileptologist and assistant professor of neurology at the University of Pennsylvania who was not part of the study, said to NeurologyLive.2
“As the largest prospective clinical study in the field of neuromodulation with 9-year follow up, this Long-Term Treatment Study marks a significant milestone for clinicians and patients alike, demonstrating that responsive neurostimulation proves to be a safe and effective treatment over time for individuals living with medically refractory epilepsy,” Dileep Nair, MD, a paid consultant to NeuroPace, the principal investigator of the study, and the section head of adult epilepsy at Cleveland Clinic’s Neurological Institute, told NeurologyLive. “Results from the study conclude that patients not only experienced significant seizure reduction, but improved quality of life and cognitive benefits.”
The trial consisted of 256 patients from more than 300 epilepsy centers, totaling more than 19000 patient implant years of follow-up data. Patients in the trial had a median of 10 seizures per month at baseline.
Additional clinical outcomes included 28% of patients experiencing seizure-free periods of 6 months or longer, and 18% of patients experiencing those same periods of 1-year or longer. The quality of life measures, such as memory and cognition, were sustained through the 9-year study period, with no reported chronic stimulation-related adverse effects.
"This study further proves that neuromodulation is an effective treatment for epilepsy patients who are refractory to medication," Nair said. "Another exciting benefit of this technology is that it provides clinicians with ongoing neural recordings to personalize treatment. This research advances our understanding of responsive neurostimulation, which holds the possibility of treating other debilitating neurological conditions."
The system is the first and only of its kind approved by the FDA, which utilizes technology that allows for the brain to interface with the computer, resulting in a brain-responsive structure. According to NeuroPace, its RNS System is now available at nearly all comprehensive epilepsy centers in the United States and is widely covered by both private and government insurance plans.
The Next-Gen version of the RNS System officially launched on June 1, 2018. The advancement allowed for the battery life of the RNS Neurostimulator to more than double, from 3.9 years to 8.4 years, when used at medium stimulation settings. Additionally, the amount of available memory also doubled, which allows physicians to review a wider set of brain activity data.3
“We are excited about the strong results demonstrated in our Long-Term Treatment Study, but we recognize that this is just the beginning,” NeuroPace Chief Medical Officer Martha Morrell, MD, said. “The neural recording capability of the RNS System provides us with an unprecedented window to the brain. Our research focus now is to apply artificial intelligence to this rich data set to optimize therapy settings and improve clinical outcomes faster. The neural data has revealed remarkable discoveries about how the brain functions over months and years—these insights have the potential to lead to the treatment of other brain disorders that affect millions of people worldwide.”
1. NeuroPace Announces Final Results from the Largest Prospective Clinical Study in the Field of Neuromodulation with 9-Year Follow-Up at the 2018 American Epilepsy Society Annual Meeting [press release]. New Orleans, Lousiana; NeuroPace; Published December 3, 2018. neuropace.com/neuropace-announces-final-results-largest-prospective-clinical-study. Accessed December 3, 2018.
2. Davis K. Kate Davis, MD, MSTR: Cognitive Issues In Epilepsy. NeurologyLive website. neurologylive.com/conferences/ana-2018/kate-davis-cognitive-issues-epilepsy. Published October 22, 2018. Accessed December 3, 2018.
NeuroPace Launches Next Generation RNS System, the World’s Only Brain-Computer Interface for the Treatment of Refractory Epilepsy [press release]. Mountain View, California; NeuroPace; Published June 1, 2018. neuropace.com/neuropace-launches-next-generation-rns-system. Accessed December 3, 2018.