Yang Yanfeng, Wei Penghu, Shi Jianwei, Mao Ying, Zhang Jianmin, Lei Ding, Yang Zhiquan, Song Shiwei, Qian Ruobing, Li Wenling, Shan Yongzhi, Zhao Guoguang
Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.
Department of Neurosurgery, Huashan Hospital, Fudan University, Shanghai 200040, China.
Chin Med J (Engl). 2025 Feb 20;138(4):430-440. doi: 10.1097/CM9.0000000000003292. Epub 2024 Nov 27.
To evaluate the efficacy and safety of the first cohort of people in China treated with a responsive neurostimulation system (Epilcure TM , GenLight MedTech, Hangzhou, China) for focal drug-resistant epilepsy in this study.
This multicenter, before-and-after self-controlled study was conducted across 8 centers from March 2022 to June 2023, involving patients with drug-resistant epilepsy who were undergoing responsive neurostimulation (RNS). The study was based on an ongoing multi-center, single-blind, randomized controlled study. Efficacy was assessed through metrics including median seizure count, seizure frequency reduction (SFR), and response rate. Multivariable linear regression analysis was conducted to explore the relationships of basic clinical factors and intracranial electrophysiological characteristics with SFR. The postoperative quality of life, cognitive function, depression, and anxiety were evaluated as well.
The follow-up period for the 19 participants was 10.7 ± 3.4 months. Seizure counts decreased significantly 6 months after device activation, with median SFR of 48% at the 6th month (M6) and 58% at M12 ( P <0.05). The average response rate after 13 months of treatment was 42%, with 21% ( n = 4) of the participants achieving seizure freedom. Patients who have previously undergone resective surgery appear to achieve better therapeutic outcomes at M11, M12 and M13 ( β <0, P <0.05). No statistically significant differences were observed in patients' scores of quality of life, cognition, depression and anxiety following stimulation when compared to baseline measurements. No serious adverse events related to the devices were observed.
The preliminary findings suggest that Epilcure TM exhibits promising therapeutic potential in reducing the frequency of epileptic seizures. However, to further validate its efficacy, larger-scale randomized controlled trials are required.
Chinese Clinical Trial Registry (No. ChiCTR2200055247).
本研究旨在评估中国首批使用响应性神经刺激系统（Epilcure TM，杭州健新原力医药科技有限公司）治疗局灶性耐药性癫痫患者的疗效和安全性。
本多中心自身前后对照研究于2022年3月至2023年6月在8个中心开展，纳入接受响应性神经刺激（RNS）治疗的耐药性癫痫患者。该研究基于一项正在进行的多中心、单盲、随机对照研究。通过中位数发作次数、发作频率降低率（SFR）和缓解率等指标评估疗效。进行多变量线性回归分析以探讨基本临床因素和颅内电生理特征与SFR的关系。同时评估术后生活质量、认知功能、抑郁和焦虑情况。
19名参与者的随访期为10.7±3.4个月。设备激活6个月后发作次数显著减少，第6个月（M6）的SFR中位数为48%，第12个月（M12）为58%（P<0.05）。治疗13个月后的平均缓解率为42%，21%（n=4）的参与者实现无发作。既往接受过切除性手术的患者在M11、M12和M13时似乎取得了更好的治疗效果（β<0，P<0.05）。与基线测量相比，刺激后患者的生活质量、认知、抑郁和焦虑评分未观察到统计学显著差异。未观察到与设备相关的严重不良事件。
初步研究结果表明，Epilcure TM在降低癫痫发作频率方面显示出有前景的治疗潜力。然而，为进一步验证其疗效，需要开展更大规模的随机对照试验。
中国临床试验注册中心（注册号：ChiCTR2200055247）
