脑反应性神经刺激治疗局灶性癫痫的 9 年疗效和安全性前瞻性研究。
Nine-year prospective efficacy and safety of brain-responsive neurostimulation for focal epilepsy.
机构信息
From the Cleveland Clinic Foundation (D.R.N., A.V.A.), OH; California Pacific Medical Center (K.D.L., P.B.W.), San Francisco; Augusta University (A.M.M., Y.D.P.), GA; Henry Ford Hospital (G.L.B.), Detroit, MI; Ohio Health Neuroscience (B.J.S.), Columbus; Swedish Neuroscience Institute (R.P.G., M.J.D.), Seattle, WA; Mayo Clinic Arizona (K.H.N., R.S.Z.), Scottsdale; Johns Hopkins Medicine (G.K.B., W.S.A.), Baltimore, MD; Keck School of Medicine of USC (C.H., C.Y.L.), Los Angeles, CA; Via Christi Epilepsy Center (R.W.L., T.S.), Wichita, KS; Yale University School of Medicine (R.B.D., L.J.H.), New Haven, CT; Mayo Clinic Florida (R.E.W., W.T.), Jacksonville; Columbia University Medical Center (S.S., G.M.M.), New York, NY; University of Texas Southwestern Medical Center (M.A.A.), Dallas; Geisel School of Medicine at Dartmouth (B.C.J., D.W.R.), Hanover, NH; Indiana University School of Medicine (V.S., T.C.W.), Indianapolis; Massachusetts General Hospital (S.S.C., A.J.C.), Boston; Mayo Clinic Minnesota (G.A.W., B.N.L.), Rochester; Medical University of South Carolina (J.C.E., J.J.H.), Charleston; Oregon Health & Science University (D.C. Spencer, L.E.), Portland; Thomas Jefferson University (C.T.S., M.R.S.), Philadelphia, PA; Nicklaus Children's Hospital (I.M.), Miami, FL; Saint Barnabas Medical Center (E.B.G.), Livingston, NJ; University of Rochester Medical Center (M.J.B., A.J.F.), NY; University of Wisconsin Hospital and Clinics (P.R.), Madison; Baylor College of Medicine (A.M.G., E.M.M.), Houston, TX; Emory University School of Medicine (R.E.G.), Atlanta, GA; George Washington University School of Medicine and Health Sciences (D.C. Shields), Washington, DC; Weill Cornell Medical College (T.H.S., D.R.L.), New York, NY; University of Virginia School of Medicine (N.B.F., W.J.E.), Charlottesville; Louisiana State University Health Sciences Center (P.W.O., N.R.V.-P.), New Orleans; University of Florida (S.E., S.N.R.), Gainesville; Wake Forest University Health Sciences (J.G.B.), Winston-Salem, NC; NeuroPace, Inc (T.A.C., F.T.S., C.G.S., K.L.M., T.L.S., M.J.M.), Mountain View; and Stanford University (M.J.M.), Palo Alto, CA.
出版信息
Neurology. 2020 Sep 1;95(9):e1244-e1256. doi: 10.1212/WNL.0000000000010154. Epub 2020 Jul 20.
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% ( < 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 ( < 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 ( < 0.05, 1-tailed χ).
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.
CLINICALTRIALSGOV 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.
目的
前瞻性评估脑反应性神经刺激在 9 年内对药物难治性局灶性发作性癫痫（FOS）成人的安全性和疗效。
方法
在为期 2 年的可行性或随机对照试验中接受脑反应性神经刺激治疗的成年人被纳入一项长期前瞻性开放标签试验（LTT），以评估另外 7 年内的安全性、疗效和生活质量（QOL）。安全性评估为不良事件（AE），疗效评估为癫痫频率的中位数百分比变化和应答率，生活质量评估采用癫痫生活质量问卷（QOLIE-89）。
结果
在最初的试验中，256 名患者中有 230 名参加了 LTT。9 年后，癫痫发作频率的中位数降低了 75%（<0.0001，Wilcoxon 符号秩检验），应答率为 73%，35%的患者癫痫发作频率降低了≥90%。我们发现 18.4%（256 例中有 47 例）有≥1 年的无癫痫发作，62%（47 例中有 29 例）在最后一次随访时无癫痫发作，无癫痫发作的平均时间为 3.2 年（范围为 1.04-9.6 年）。总体生活质量和癫痫目标以及 QOLIE-89 的认知领域均显著改善（<0.05）。没有与刺激相关的严重 AE，且突然不明原因的癫痫死亡（SUDEP）发生率明显低于预设的对照组（<0.05，单侧 χ检验）。
结论
辅助性脑反应性神经刺激可显著减少 FOS 的发作频率，并提高生活质量。刺激耐受性良好；与植入相关的 AE 是其他神经刺激装置的典型表现；SUDEP 发生率较低。
临床试验.gov 标识符：NCT00572195.
证据分类
这项研究提供了 IV 级证据，表明脑反应性神经刺激在 9 年内可显著降低局灶性癫痫发作，且安全性可接受。
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