Preliminary experience with a new system for vagus nerve stimulation for the treatment of refractory focal onset seizures
Preliminary experience with a new system for vagus nerve stimulation for the treatment of refractory focal onset seizures
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DOI：
10.1016/j.yebeh.2013.08.014
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发表时间：
2013-11-01
影响因子：
2.6
通讯作者：
Silander, Hans
中科院分区：
文献类型：
--
作者：
Ben-Menachem, Elinor;Rydenhag, Bertil;Silander, Hans
迷走神经刺激（VNS）是治疗耐药性癫痫的公认疗法。新的VNS系统（“FitNeS”;由BioControl Medical（B.C.M.）有限公司、Yehud，Israel）植入5例难治性局灶性癫痫患者。该系统由一个可编程脉冲发生器和一个能够提供单向刺激的袖带电极组成，这两个电极分别植入左胸和颈部。FitNeS是基于RightFit迷走神经刺激系统，该系统用于治疗心力衰竭，目前正在进行随机对照III期临床试验，5例患者的长期刺激导致2例患者癫痫发作减少50%，2例患者减少25%，1例患者无效，很少有关于副作用的报道。在低于2 mA的刺激水平下，没有声音嘶哑的投诉，也没有吞咽困难或咳嗽的报告。缺乏感知刺激效应可能最终允许设计一个真正的盲随机对照研究，以评估VNS与安慰剂相比的疗效。(C)2013 Elsevier Inc. All rights reserved.
Vagus nerve stimulation (VNS) is an accepted therapy for the treatment of drug-resistant epilepsy. A new VNS system ("FitNeS"; manufactured by BioControl Medical (B.C.M.) Ltd., Yehud, Israel) was implanted in 5 patients with refractory focal epilepsy. The system is composed of a programmable pulse generator and a cuff electrode that is able to provide unidirectional stimulation, both of which are implanted in the left chest and in the neck, respectively. FitNeS is based on the CardioFit vagus nerve stimulation system, which is intended for the treatment of heart failure and which is currently in a randomized controlled phase III clinical trial.Long-term stimulation in the 5 patients resulted in a 50% seizure reduction in 2 patients, 25% in 2 patients, and no effect in one patient, with few reports concerning side effects. There were no complaints of hoarseness at levels of stimulation below 2 mA nor were there any reports of dysphagia or cough. The lack of perceived stimulation effects might finally allow for the design of a truly blinded randomized controlled study to evaluate the efficacy of VNS compared to placebo. (C) 2013 Elsevier Inc. All rights reserved.