Early assessment of responsive neurostimulation for drug-resistant epilepsy in China: A multicenter, self-controlled study.

IF 7.5 3区医学 Q1 MEDICINE, GENERAL & INTERNAL Chinese Medical Journal Pub Date : 2024-11-27 DOI:10.1097/CM9.0000000000003292

Yanfeng Yang, Penghu Wei, Jianwei Shi, Ying Mao, Jianmin Zhang, Ding Lei, Zhiquan Yang, Shiwei Song, Ruobing Qian, Wenling Li, Yongzhi Shan, Guoguang Zhao

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Abstract

Background: To evaluate the efficacy and safety of the first cohort of people in China treated with a responsive neurostimulation system (EpilcureTM, GenLight MedTech, Hangzhou, China) for focal drug-resistant epilepsy in this study.

Methods: 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. Multivariate linear regression 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.

Results: 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.

Conclusions: The preliminary findings suggest that EpilcureTM exhibits promising therapeutic potential in reducing the frequency of epileptic seizures. However, to further validate its efficacy, larger-scale randomized controlled trials are required.

Registration: Chinese Clinical Trial Registry (No. ChiCTR2200055247).

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中国早期评估反应性神经刺激治疗耐药性癫痫：一项多中心自控研究。

背景：评估中国首批接受反应性神经刺激系统（EpilcureTM，GenLight MedTech，中国杭州）治疗局灶性耐药癫痫患者的疗效和安全性：这项多中心、前后自对照研究于2022年3月至2023年6月在8个中心开展，涉及接受反应性神经刺激（RNS）治疗的耐药癫痫患者。该研究基于一项正在进行的多中心、单盲、随机对照研究。疗效评估指标包括发作次数中位数、发作频率降低（SFR）和反应率。多变量线性回归探讨了基本临床因素和颅内电生理特征与 SFR 的关系。此外，还对术后生活质量、认知功能、抑郁和焦虑进行了评估：结果：19 名参与者的随访时间为 10.7 ± 3.4 个月。设备激活 6 个月后，癫痫发作次数明显减少，第 6 个月（M6）的 SFR 中位数为 48%，第 12 个月（M12）的 SFR 中位数为 58%：初步研究结果表明，EpilcureTM 在降低癫痫发作频率方面具有良好的治疗潜力。然而，要进一步验证其疗效，还需要进行更大规模的随机对照试验：注册：中国临床试验注册中心（编号：ChiCTR2200055247）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Chinese Medical Journal 医学-医学：内科

CiteScore

9.80

自引率

4.90%

发文量

19245

审稿时长

6 months

期刊介绍： The Chinese Medical Journal (CMJ) is published semimonthly in English by the Chinese Medical Association, and is a peer reviewed general medical journal for all doctors, researchers, and health workers regardless of their medical specialty or type of employment. Established in 1887, it is the oldest medical periodical in China and is distributed worldwide. The journal functions as a window into China’s medical sciences and reflects the advances and progress in China’s medical sciences and technology. It serves the objective of international academic exchange. The journal includes Original Articles, Editorial, Review Articles, Medical Progress, Brief Reports, Case Reports, Viewpoint, Clinical Exchange, Letter,and News,etc. CMJ is abstracted or indexed in many databases including Biological Abstracts, Chemical Abstracts, Index Medicus/Medline, Science Citation Index (SCI), Current Contents, Cancerlit, Health Plan & Administration, Embase, Social Scisearch, Aidsline, Toxline, Biocommercial Abstracts, Arts and Humanities Search, Nuclear Science Abstracts, Water Resources Abstracts, Cab Abstracts, Occupation Safety & Health, etc. In 2007, the impact factor of the journal by SCI is 0.636, and the total citation is 2315.