Responsive Neurostimulation For The Treatment Of Refractory Focal Epilepsy

Approximately one-third of individuals with epilepsy do not respond to typical first-line therapy with antiepileptic medications. Seizures that occur in these individuals are referred to as refractory or drug-resistant. In individuals with refractory epilepsy, combination antiepileptic therapy often results in increased risk of adverse events. Other nonpharmacologic treatment options are available, including surgical approaches, ketogenic diet, and responsive neurostimulation. One responsive neurostimulation device, the NeuroPace RNS System, has U.S. Food and Drug Administration (FDA) approval for the treatment of refractory focal (formerly partial) epilepsy. Summary – Intro Responsive neurostimulation for the treatment of epilepsy involves the use of 1 or more implantable electric leads that serve both a seizure detection and neurostimulation function. The device is programmed using a proprietary algorithm to recognize seizure patterns from electrocorticography output and to deliver electrical stimulation with the goal of terminating a seizure. The NeuroPace RNS System has U.S. FDA approval for the treatment of refractory focal (formerly partial) epilepsy. For individuals who have refractory focal epilepsy who receive responsive neurostimulation, the evidence includes an industry-sponsored randomized controlled trial, which was used for FDA approval of the NeuroPace RNS System, as well as several published follow-up analyses.. Relevant outcomes are symptoms, morbid events, quality of life, and treatment-related mortality and morbidity. The randomized controlled trial was well-designed and well-conducted; it reported that responsive neurostimulation is associated with improvements in mean seizure frequency in individuals with refractory focal epilepsy, with an absolute difference in change in seizure frequency of about 20% between groups; however, the percentage of treatment responders with at least a 50% reduction in seizures did not differ from sham control. Overall, the results suggested a modest reduction in seizure frequency in a subset of individuals. The number of adverse events reported in the available studies is low, although the data on adverse events were limited because of small study samples. Generally, individuals who are candidates for responsive neurostimulation are severely debilitated and have few other treatment options, so the benefits are likely high relative to the risks. In particular, individuals who are not candidates for resective epilepsy surgery and have few treatment options may benefit from responsive neurostimulation. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome. Additional Information Not applicable. >