文摘
摘要目的:本研究报告传统表面肌电图(表)的效用分析临床发作符号学。
背景:大脑哨兵®开发了一种基于表的,实时的,广义强直性阵挛性发作(gtc)检测系统,验证前瞻性,双盲,多中心,三期临床试验。适当的位置在肱二头肌肌肉是检测的关键。当妥善放置,系统检测到29/29吸收(100% CI[0.90, 1.0])记录在癫痫患者癫痫监测单位。数据记录在这些总会比较符号学被vEEG审查确定可能的临床效用。
设计/方法:总共11 NAEC IV级中心前瞻性的199患者吸收的历史。他们进行vEEG监测根据标准临床护理的同时使用大脑前哨设备监控。单方面面肌电信号被记录在肱二头肌肌肉。vEEG监测由3独立审阅委员会认证epileptologists转让发作分类、脑电图仪的出现,出现非面部运动表现,和持续时间的GTC发作的主音和阵挛性的阶段。持续时间的视觉识别在面肌录音tonic-clonic阶段。
结果:三个epileptologists高一致性(AC2 = 0.78),而独立识别共24例,总共经历了29 GTC发作,而设备正常和记录摘要。四个主要发作癫痫患者经历了5,GTC发作和20个病人经历了24其次吸收。主音和阵挛性的阶段记录面肌的吸收都是可观测的。tonic-clonic阶段的平均时间为56.90秒,能够观察到类似vEEG回顾(51.37秒)。
结论:主音和阵挛性的阶段的持续时间的吸收可能量化表数据记录下大脑哨兵设备。设备可以提供临床相关也是兼职vEEG监控或独立的数据。
研究支持:
大脑哨兵赞助这个关键,双盲,多中心,前瞻性的临床试验。
披露:何塞·e·卡瓦博士已经收到个人赔偿大脑前哨担任顾问。哈尔福德博士已经收到个人活动与大脑前哨,补偿Acorda疗法,卫材公司联合制药,Lundbeck公司研究它是一家美国公司,Validus制药,Upsher-Smith。哈尔福德博士收到Acorda研究支持疗法,卫材公司LCGH,瓦制药、Lundbeck公司研究它是一家美国公司,神经科学最适条件,UCB制药,癫痫研究财团。斯珀林博士已经收到个人补偿活动起到了与美敦力公司担任顾问。斯珀林博士已经收到UCB制药研究支持,卫材、Sunovion,葛兰素史克,SK生命科学,Upsher史密斯Neurelis, Accorda,美敦力公司,和大脑前哨。奈尔博士没有披露。Dlugos博士获得了支持大脑前哨,Inc .泰特姆博士收到演示出版商和爱思唯尔的特许使用金。哈维博士已经收到个人活动与Sunovion补偿,UCB制药,Cyberonics。哈维博士已经收到Sunovion研究支持,联合制药公司,辉瑞公司SK生活,绿,Acorda, Upsher史密斯,吉瓦,默克、鼠尾草和大脑前哨。法国博士已经收到个人活动与Acorda补偿,金刚石,Alexza, Anavex,生原体,BioPharm解决方案,Cerecor,音乐会制药、Convance,卫材,格鲁吉亚评议大学,葛兰素史克,瓦制药,绿,MonosolRx, Monteris, Nestle-Health科学,Neurelis,诺华,奥维德疗法公司,辉瑞,Pfizer-Neusentis, Pronutria, Roivant,鼠尾草,SK生命科学、Sunovion, Supernus,武田,UCB Inc . Upsher史密斯,氙制药、Zogenix, Zynerba作为顾问。 Dr. Pollard has received personal compensation for activities with Cognizance Biomarkers as a part-owner. Dr. Pollard has received research support from Glaxo-Smith Kline, Cognizance Biomarkers, SK Pharmaceuticals, Alexza Pharmaceuticals, Pfizer, and Upsher-Smith Laboratories. Dr. Faught has received personal compensation for Eisai, Lundbeck, SK Life Science, Sunovion, and UCB Pharma as a consultant. Dr. Faught has received research support from Emory University from Brain Sentinel and UCB Pharmaresearch. Dr. Noe has received research support from NeuroPace. Dr. Henry has received research support from Brain Sentinel. Dr. Jetter has received research support from Brain Sentinel. Dr. Lie has received research support from Brain Sentinel. Dr. Morgan has received research support from Brain Sentinel. Dr. Girouard has received personal compensation for activities with Brain Sentinel as an employee. Dr. Cardenas has nothing to disclose. Dr. Whitmire has received personal compensation for activities with Brain Sentinel as employee.
