{"title":"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。","authors":"Yanfeng Yang, Penghu Wei, Jianwei Shi, Ying Mao, Jianmin Zhang, Ding Lei, Zhiquan Yang, Shiwei Song, Ruobing Qian, Wenling Li, Yongzhi Shan, Guoguang Zhao","doi":"10.1097/CM9.0000000000003292","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Registration: </strong>Chinese Clinical Trial Registry (No. ChiCTR2200055247).</p>","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":""},"PeriodicalIF":7.5000,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Early assessment of responsive neurostimulation for drug-resistant epilepsy in China: A multicenter, self-controlled study.\",\"authors\":\"Yanfeng Yang, Penghu Wei, Jianwei Shi, Ying Mao, Jianmin Zhang, Ding Lei, Zhiquan Yang, Shiwei Song, Ruobing Qian, Wenling Li, Yongzhi Shan, Guoguang Zhao\",\"doi\":\"10.1097/CM9.0000000000003292\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Registration: </strong>Chinese Clinical Trial Registry (No. ChiCTR2200055247).</p>\",\"PeriodicalId\":10183,\"journal\":{\"name\":\"Chinese Medical Journal\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":7.5000,\"publicationDate\":\"2024-11-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Chinese Medical Journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/CM9.0000000000003292\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Chinese Medical Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/CM9.0000000000003292","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Early assessment of responsive neurostimulation for drug-resistant epilepsy in China: A multicenter, self-controlled study.
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).
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.
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