Long-term treatment with responsive brain stimulation in adults with refractory partial seizures.
Long-term treatment with responsive brain stimulation in adults with refractory partial seizures.
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DOI：
10.1212/wnl.0000000000001280
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发表时间：
2015-02-24
期刊：
影响因子：
9.9
通讯作者：
Seale CG
中科院分区：
文献类型：
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作者：
Bergey GK;Morrell MJ;Mizrahi EM;Goldman A;King-Stephens D;Nair D;Srinivasan S;Jobst B;Gross RE;Shields DC;Barkley G;Salanova V;Olejniczak P;Cole A;Cash SS;Noe K;Wharen R;Worrell G;Murro AM;Edwards J;Duchowny M;Spencer D;Smith M;Geller E;Gwinn R;Skidmore C;Eisenschenk S;Berg M;Heck C;Van Ness P;Fountain N;Rutecki P;Massey A;O'Donovan C;Labar D;Duckrow RB;Hirsch LJ;Courtney T;Sun FT;Seale CG
评估了反应性直接神经刺激对医学难治性部分发作的成人的长期疗效和安全性。所有参与者都接受颅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（RNS系统）时，通过长期植入的电极向1或2个癫痫灶提供刺激。参与者完成了为期2年的主要开放标签安全性研究（n = 65）或为期2年的随机盲法对照安全性和有效性研究（n = 191）；230名参与者转入了一项正在进行的为期7年的研究，以评估安全性和有效性。参与者平均年龄34（±11.4）岁，癫痫发作19.6（±11.4）年。植入前致残性部分或全身性强直阵挛发作的中位数频率为每月10.2次。在随机盲法对照试验中，1年和2年癫痫发作减少的中位数百分比分别为44%和53% （p < 0.0001，广义估计方程），在长期研究中，植入后3 - 6年的癫痫发作减少率为48% - 66%。生活质量的改善得以维持（p < 0.05）。在平均5.4年的随访中，最常见的严重器械相关不良事件是种植体部位感染（9.0%），涉及软组织和神经刺激器外植（4.7%）。RNS系统是第一个直接的大脑反应性神经刺激器。在平均5.4年的随访中，在由1或2个病灶引起的医学难治性部分性癫痫的成人中证明了急性和持续的有效性和安全性。这一经验支持RNS系统作为难治性部分性癫痫的治疗选择。这项研究提供了IV级证据，在平均5.4年的随访中，对于医学上难治性部分发作性癫痫的成人，反应性直接皮层刺激可减少癫痫发作并提高生活质量。
The long-term efficacy and safety of responsive direct neurostimulation was assessed in adults with medically refractory partial onset seizures. 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. 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%). 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. 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.