对难治性部分性癫痫成人患者进行响应性脑刺激的长期治疗。
Long-term treatment with responsive brain stimulation in adults with refractory partial seizures.
作者信息
Bergey Gregory K, Morrell Martha J, Mizrahi Eli M, Goldman Alica, King-Stephens David, Nair Dileep, Srinivasan Shraddha, Jobst Barbara, Gross Robert E, Shields Donald C, Barkley Gregory, Salanova Vicenta, Olejniczak Piotr, Cole Andrew, Cash Sydney S, Noe Katherine, Wharen Robert, Worrell Gregory, Murro Anthony M, Edwards Jonathan, Duchowny Michael, Spencer David, Smith Michael, Geller Eric, Gwinn Ryder, Skidmore Christopher, Eisenschenk Stephan, Berg Michel, Heck Christianne, Van Ness Paul, Fountain Nathan, Rutecki Paul, Massey Andrew, O'Donovan Cormac, Labar Douglas, Duckrow Robert B, Hirsch Lawrence J, Courtney Tracy, Sun Felice T, Seale Cairn G
机构信息
Author affiliations are provided at the end of the article.
出版信息
Neurology. 2015 Feb 24;84(8):810-7. doi: 10.1212/WNL.0000000000001280. Epub 2015 Jan 23.
OBJECTIVE
The long-term efficacy and safety of responsive direct neurostimulation was assessed in adults with medically refractory partial onset seizures.
METHODS
All participants were treated with a cranially implanted responsive neurostimulator that delivers stimulation to 1 or 2 seizure foci via chronically implanted electrodes when specific electrocorticographic patterns are detected (RNS System). Participants had completed a 2-year primarily open-label safety study (n = 65) or a 2-year randomized blinded controlled safety and efficacy study (n = 191); 230 participants transitioned into an ongoing 7-year study to assess safety and efficacy.
RESULTS
The average participant was 34 (±11.4) years old with epilepsy for 19.6 (±11.4) years. The median preimplant frequency of disabling partial or generalized tonic-clonic seizures was 10.2 seizures a month. The median percent seizure reduction in the randomized blinded controlled trial was 44% at 1 year and 53% at 2 years (p < 0.0001, generalized estimating equation) and ranged from 48% to 66% over postimplant years 3 through 6 in the long-term study. Improvements in quality of life were maintained (p < 0.05). The most common serious device-related adverse events over the mean 5.4 years of follow-up were implant site infection (9.0%) involving soft tissue and neurostimulator explantation (4.7%).
CONCLUSIONS
The RNS System is the first direct brain responsive neurostimulator. Acute and sustained efficacy and safety were demonstrated in adults with medically refractory partial onset seizures arising from 1 or 2 foci over a mean follow-up of 5.4 years. This experience supports the RNS System as a treatment option for refractory partial seizures.
CLASSIFICATION OF EVIDENCE
This study provides Class IV evidence that for adults with medically refractory partial onset seizures, responsive direct cortical stimulation reduces seizures and improves quality of life over a mean follow-up of 5.4 years.
目的
评估反应性直接神经刺激对药物难治性局灶性发作成年患者的长期疗效和安全性。
方法
所有参与者均接受了颅内植入的反应性神经刺激器治疗，当检测到特定的皮质电图模式时，该刺激器通过长期植入的电极向1个或2个癫痫病灶传递刺激（RNS系统）。参与者已完成一项为期2年的主要为开放标签的安全性研究（n = 65）或一项为期2年的随机双盲对照安全性和疗效研究（n = 191）；230名参与者转入一项正在进行的7年研究以评估安全性和疗效。
结果
参与者的平均年龄为34（±11.4）岁，癫痫病史为19.6（±11.4）年。植入前致残性局灶性或全身性强直阵挛发作的中位数频率为每月10.2次发作。在随机双盲对照试验中，1年时发作减少的中位数百分比为44%，2年时为53%（p < 0.0001，广义估计方程），在长期研究中，植入后第3年至第6年的发作减少幅度为48%至66%。生活质量得到维持（p < 0.05）。在平均5.4年的随访中，最常见的与设备相关的严重不良事件是植入部位感染（9.0%），涉及软组织和神经刺激器取出（4.7%）。
结论
RNS系统是首个直接作用于大脑的反应性神经刺激器。在平均随访5.4年的时间里，对1个或2个病灶引起的药物难治性局灶性发作成年患者，证实了其急性和持续的疗效及安全性。这一经验支持将RNS系统作为难治性局灶性癫痫的一种治疗选择。
证据分类
本研究提供了IV级证据，即对于药物难治性局灶性发作成年患者，反应性直接皮质刺激在平均随访5.4年的时间里可减少发作并改善生活质量。
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