Nine-year prospective efficacy and safety of brain-responsive neurostimulation for focal epilepsy
推荐理由
最早开始做RNS的neuroPace公司的LLT临床研究结果，具有很好的借鉴
| 文章简介 | |
|---|---|
| 期刊 | Neurology |
| 发表年份 | 2020 |
| DOI | 10.1212/WNL.0000000000010154 |
| 类型 | 研究性工作 |
| 领域 | 癫痫闭环 |
| 引用量 | 261 |
| 推荐信息 | |
|---|---|
| 推荐人 | 胡迎炳 |
| 审核 | 郝老师 |
| 推荐小组 | 癫痫小组 |
摘要
Objective To prospectively evaluate safety and efficacy of brain-responsive neurostimulation in adults with medically intractable focal onset seizures (FOS) over 9 years. Methods Adults treated with brain-responsive neurostimulation in 2-year feasibility or randomized controlled trials were enrolled in a long-term prospective open label trial (LTT) to assess safety, efficacy, and quality of life (QOL) over an additional 7 years. Safety was assessed as adverse events (AEs), efficacy as median percent change in seizure frequency and responder rate, and QOL with the Quality of Life in Epilepsy (QOLIE-89) inventory. Results Of 256 patients treated in the initial trials, 230 participated in the LTT. At 9 years, the median percent reduction in seizure frequency was 75% (p < 0.0001, Wilcoxon signed rank), responder rate was 73%, and 35% had a >= 90% reduction in seizure frequency. We found that 18.4% (47 of 256) experienced >= 1 year of seizure freedom, with 62% (29 of 47) seizure-free at the last follow-up and an average seizure-free period of 3.2 years (range 1.04-9.6 years). Overall QOL and epilepsy-targeted and cognitive domains of QOLIE-89 remained significantly improved (p < 0.05). There were no serious AEs related to stimulation, and the sudden unexplained death in epilepsy (SUDEP) rate was significantly lower than predefined comparators (p < 0.05, 1-tailed chi(2)). Conclusions Adjunctive brain-responsive neurostimulation provides significant and sustained reductions in the frequency of FOS with improved QOL. Stimulation was well tolerated; implantation-related AEs were typical of other neurostimulation devices; and SUDEP rates were low. ClinicalTrials.gov identifier NCT00572195. Classification of evidence This study provides Class IV evidence that brain-responsive neurostimulation significantly reduces focal seizures with acceptable safety over 9 years.
细分领域
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