Meador Kimford J, Kapur Ritu, Loring David W, Kanner Andres M, Morrell Martha J
Department of Neurology and Neurological Sciences, Stanford University Medical Center, 300 Pasteur Drive, Stanford, CA 94305, USA.
NeuroPace, Inc., 455 N Bernardo Drive, Mountain View, CA 94043, USA.
Epilepsy Behav. 2015 Apr;45:242-7. doi: 10.1016/j.yebeh.2015.01.012. Epub 2015 Mar 26.
The primary efficacy and safety measures from a trial of responsive neurostimulation for focal epilepsy were previously published. In this report, the findings from the same study are presented for quality of life, which was a supportive analysis, and for mood, which was assessed as a secondary safety endpoint.
The study was a multicenter randomized controlled double-blinded trial of responsive neurostimulation in 191 patients with medically resistant focal epilepsy. During a 4-month postimplant blinded period, patients were randomized to receive responsive stimulation or sham stimulation, after which all patients received responsive neurostimulation in open label to complete 2years. Quality of life (QOL) and mood surveys were administered during the baseline period, at the end of the blinded period, and at year 1 and year 2 of the open label period.
The treatment and sham groups did not differ at baseline. Compared with baseline, QOL improved in both groups at the end of the blinded period and also at 1year and 2years, when all patients were treated. At 2years, 44% of patients reported meaningful improvements in QOL, and 16% reported declines. There were no overall adverse changes in mood or in suicidality across the study. Findings were not related to changes in seizures and antiepileptic drugs, and patients with mesial temporal seizure onsets and those with neocortical seizure onsets both experienced improvements in QOL.
Treatment with targeted responsive neurostimulation does not adversely affect QOL or mood and may be associated with improvements in QOL in patients, including those with seizures of either mesial temporal origin or neocortical origin.
先前已发表了一项针对局灶性癫痫的反应性神经刺激试验的主要疗效和安全性指标。在本报告中，呈现了同一研究中关于生活质量（一项支持性分析）和情绪（作为次要安全性终点进行评估）的结果。
该研究是一项多中心随机对照双盲试验，对191例药物难治性局灶性癫痫患者进行反应性神经刺激。在植入后4个月的盲法期内，患者被随机分配接受反应性刺激或假刺激，之后所有患者接受开放标签的反应性神经刺激以完成2年的研究。在基线期、盲法期末、开放标签期的第1年和第2年进行生活质量（QOL）和情绪调查。
治疗组和假刺激组在基线时无差异。与基线相比，在盲法期末以及所有患者接受治疗的第1年和第2年，两组的生活质量均有所改善。在2年时，44%的患者报告生活质量有显著改善，16%的患者报告生活质量下降。在整个研究过程中，情绪或自杀倾向没有总体不良变化。研究结果与癫痫发作和抗癫痫药物的变化无关，内侧颞叶癫痫发作患者和新皮质癫痫发作患者的生活质量均有所改善。
靶向反应性神经刺激治疗不会对生活质量或情绪产生不利影响，并且可能与患者生活质量的改善相关，包括内侧颞叶起源或新皮质起源癫痫发作的患者。
