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首页> 外文期刊>Trials >High frequency oscillations in the intra-operative ECoG to guide epilepsy surgery (“The HFO Trial”): study protocol for a randomized controlled trial
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High frequency oscillations in the intra-operative ECoG to guide epilepsy surgery (“The HFO Trial”): study protocol for a randomized controlled trial

机译：术中ECoG的高频振荡指导癫痫手术（“ HFO试验”）：一项随机对照试验的研究方案

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Background Intra-operative electrocorticography, based on interictal spikes and spike patterns, is performed to optimize delineation of the epileptogenic tissue during epilepsy surgery. High frequency oscillations (HFOs, 80–500 Hz) have been identified as more precise biomarkers for epileptogenic tissue. The aim of the trial is to determine prospectively if ioECoG-tailored surgery using HFOs, instead of interictal spikes, is feasible and will lead to an equal or better seizure outcome. MethodsDesign We present a single-blinded multi-center randomized controlled trial “The HFO Trial” including patients with refractory focal epilepsy of all ages who undergo surgery with intra-operative electrocorticography. Surgery is tailored by HFOs (arm 1) or interictal spikes (arm 2) in the intra-operative electrocorticography. Primary outcome is post-operative outcome after 1 year, dichotomized in seizure freedom (Engel 1A and 1B) versus seizure recurrence (Engel 1C-4). Secondary outcome measures are the volume of resected tissue, neurologic deficits, surgical duration and complications, cognition and quality of life. The trial has a non-inferiority design to test feasibility and at least equal performance in terms of surgical outcome. We aim to include 78 patients within 3 years including 1 year follow-up. Results are expected in 2018. Discussion This trial provides a transition from observational research towards clinical interventions using HFOs. We address methodological difficulties in designing this trial. We expect that the use of HFOs as a biomarker for tailoring will increase the success rate of epilepsy surgery while reducing resection volume. This may reduce neurological deficits and yield a better quality of life. Future technical developments, such as validated automatic online HFO identification, could, together with the attained clinical knowledge, lead to a new objective tailoring approach in epilepsy surgery. Trial registration This trial is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT02207673 (31 July 2014) and the Central Committee on Research Involving Human Subjects, The Netherlands #NL44257.041.13 (18 March 2014).
机译：背景技术基于间质尖峰和尖峰模式进行术中脑皮质描记术，以优化癫痫手术过程中癫痫发生组织的轮廓。高频振荡（HFO，80–500 Hz）已被识别为癫痫发生组织的更精确的生物标记。该试验的目的是前瞻性地确定采用HFO代替ioico尖峰的ioECoG量身定制的手术是否可行，并将导致相同或更好的癫痫发作结果。方法设计我们提供了一项单盲多中心随机对照试验“ HFO试验”，该试验包括所有年龄段的难治性癫痫患者，并接受了术中脑电图术。手术是通过术中脑皮质描记术中的HFO（臂1）或壁尖刺（臂2）定制的。主要结局是1年后的手术结局，分为癫痫发作自由度（Engel 1A和1B）与癫痫发作复发（Engel 1C-4）。次要结果指标是切除的组织量，神经功能缺损，手术时间和并发症，认知和生活质量。该试验采用非劣效性设计，以测试可行性和就手术结果而言至少具有同等性能。我们的目标是在3年内纳入78名患者，包括1年的随访。预计将于2018年获得结果。讨论该试验提供了从观察性研究到使用HFO进行临床干预的过渡。我们解决了设计该试验的方法学难题。我们期望将HFO用作剪裁的生物标记物将提高癫痫手术的成功率，同时减少切除的体积。这可以减少神经功能缺损，并改善生活质量。未来的技术发展，例如经过验证的自动在线HFO识别，可以与获得的临床知识一起，导致癫痫外科手术中一种新的客观定制方法。试验注册该试验在美国国立卫生研究院（ClinicalTrials.gov）＃NCT02207673（2014年7月31日）和荷兰人类研究中心委员会＃NL44257.041.13（2014年3月18日）进行注册。

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