Department of Neurosurgery, Tokyo Medical and Dental University.
Department of Neurosurgery, Comprehensive Epilepsy Center, Seirei Hamamatsu General Hospital.
Neurol Med Chir (Tokyo). 2021 Jan 15;61(1):1-11. doi: 10.2176/nmc.st.2020-0172. Epub 2020 Dec 2.
Patients with drug-resistant focal onset epilepsy are not always suitable candidates for resective surgery, a definitive intervention to control their seizures. The alternative surgical treatment for these patients in Japan has been vagus nerve stimulation (VNS). Besides VNS, epileptologists in the United States can choose a novel palliative option called responsive neurostimulation (RNS), a closed-loop neuromodulation system approved by the US Food and Drug Administration in 2013. The RNS System continuously monitors neural electroencephalography (EEG) activity at the possible seizure onset zone (SOZ) where electrodes are placed and responds with electrical stimulation when a pre-defined epileptic activity is detected. The controlled clinical trials in the United States have demonstrated long-term utility and safety of the RNS System. Seizure reduction rates have continued to improve over time, reaching 75% over 9 years of treatment. The incidence of implant-site infection, the most frequent device-related adverse event, is similar to those of other neuromodulation devices. The RNS System has shown favorable efficacy for both mesial temporal lobe epilepsy (TLE) and neocortical epilepsy of the eloquent cortex. Another unique advantage of the RNS System is its ability to provide chronic monitoring of ambulatory electrocorticography (ECoG). Valuable information obtained from ECoG monitoring provides a better understanding of the state of epilepsy in each patient and improves clinical management. This article reviews the developmental history, structure, and clinical utility of the RNS System, and discusses its indications as a novel palliative option for drug-resistant epilepsy.
耐药性局灶性癫痫患者并不总是适合进行切除性手术，这是一种控制癫痫发作的确定性干预措施。日本对这些患者的替代手术治疗方法一直是迷走神经刺激术（VNS）。除 VNS 外，美国的癫痫专家还可以选择一种新型的姑息治疗选择，称为反应性神经刺激术（RNS），这是一种闭环神经调节系统，于 2013 年获得美国食品和药物管理局批准。RNS 系统持续监测可能的癫痫发作起始区（SOZ）的神经脑电图（EEG）活动，当检测到预先定义的癫痫活动时，通过电刺激做出反应。美国的对照临床试验证明了 RNS 系统的长期有效性和安全性。随着时间的推移，癫痫发作减少率持续提高，在 9 年的治疗中达到 75%。植入部位感染的发生率是最常见的设备相关不良事件，与其他神经调节设备相似。RNS 系统对内侧颞叶癫痫（TLE）和语言区皮质的新皮质癫痫均显示出良好的疗效。RNS 系统的另一个独特优势是其能够提供动态脑电图（ECoG）的慢性监测。从 ECoG 监测中获得的有价值信息有助于更好地了解每位患者的癫痫状态，并改善临床管理。本文回顾了 RNS 系统的发展历史、结构和临床应用，并讨论了其作为耐药性癫痫的新型姑息治疗选择的适应证。
