Quality of life and mood in patients with medically intractable epilepsy treated with targeted responsive neurostimulation
Quality of life and mood in patients with medically intractable epilepsy treated with targeted responsive neurostimulation
复制标题
DOI：
10.1016/j.yebeh.2015.01.012
复制
发表时间：
2015-04-01
影响因子：
2.6
通讯作者：
Morrell, Martha J.
中科院分区：
文献类型：
--
作者：
Meador, Kimford J.;Kapur, Ritu;Morrell, Martha J.
目的：一项反应性神经刺激治疗局灶性癫痫的试验的主要疗效和安全性措施先前已发表。在本报告中，来自同一研究的结果显示了生活质量，这是一个支持性分析，以及情绪，这被评估为次要安全终点。方法：对191例药物抵抗性局灶性癫痫患者进行反应性神经刺激的多中心随机对照双盲试验。在4个月的刺激后盲期，患者随机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，完成2年。在基线期、盲法期结束时以及开放标签期的第1年和第2年进行生活质量（QOL）和情绪调查。结果：治疗组与假手术组在基线时无差异。与基线相比，两组患者在盲期结束时以及所有患者接受治疗后1年和2年的生活质量均有所改善。2年后，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，情绪或自杀行为没有发生总体上的不利变化。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改善。结论：靶向反应性神经刺激治疗不会对患者的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有关，包括那些颞内缘或新皮质源性癫痫发作的患者。(C) 2015年作者。Elsevier Inc.出版。
Purpose: The primary efficacy and safety measures from a trial of responsive neurostimulation for focal epilepsy were previously published. In this report, the findings fromthe same study are presented for quality of life, which was a supportive analysis, and for mood, which was assessed as a secondary safety endpoint.Methods: The study was amulticenter 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 2 years. 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.Results: 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 1 year and 2 years, when all patients were treated. At 2 years, 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.Conclusions: Treatment with targeted responsive neurostimulation does not adversely affect QOL ormood andmay be associated with improvements in QOL in patients, including those with seizures of either mesial temporal origin or neocortical origin. (C) 2015 The Authors. Published by Elsevier Inc.