Risk of seizures induced by intracranial research stimulation: analysis of 770 stimulation sessions.

Risk of seizures induced by intracranial research stimulation: analysis of 770 stimulation sessions.
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DOI:
10.1088/1741-2552/ab4365
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发表时间:
2019-11-11
影响因子:
4
通讯作者:
Sheth SA
Sheth SA
中科院分区:
工程技术2区
文献类型:
--
作者:
Goldstein HE;Smith EH;Gross RE;Jobst BC;Lega BC;Sperling MR;Worrell GA;Zaghloul KA;Wanda PA;Kahana MJ;Rizzuto DS;Schevon CA;McKhann GM;Sheth SA

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难治性癫痫患者通常接受颅内脑电监测,以确定癫痫灶并确定其是否适合手术治疗。这一临床上必要的监测期为研究人类神经生理学提供了一个越来越多地被利用的研究机会,然而,伦理方面的担忧要求彻底认识到相关的风险。我们在一个大型的多机构数据集中测量了研究性刺激相关癫痫的发生率,以确定脑刺激是否在统计学上与癫痫发生率相关,并确定刺激相关癫痫的潜在危险因素。188名接受iEEG监测的受试者参加了超过3.5年的770次研究刺激会议。我们的回顾分析包括刺激后30分钟内的癫痫发作。我们分析了刺激参数、癫痫发生率和典型的癫痫发作模式,以评估记录的癫痫发作是由刺激诱发的可能性,而不是容易发作的癫痫患者偶然发生的事件的可能性。我们的分析总共包括14次癫痫发作。所有事件均为单次发作,未发生不良事件。癫痫相关刺激的平均幅度与无癫痫发作时的平均幅度没有显著差异。为了确定癫痫发作是刺激诱发的可能性,我们使用了三组分析:视觉iEEG分析、统计频率和功率分析。我们确定14次癫痫发作中有3次可能是刺激诱发的,5次可能是刺激诱导的,6次是不太可能的刺激诱导的。总体而言,我们估计刺激诱发癫痫的比率在0.39%到1.82%之间。刺激相关癫痫的罕见,以及没有增加任何患者的发病率或影响任何患者的临床病程的事实,是了解用于研究目的的颅内刺激的可行性和安全性的重要发现。
Patients with medically refractory epilepsy often undergo intracranial electroencephalography (iEEG) monitoring to identify a seizure focus and determine their candidacy for surgical intervention. This clinically necessary monitoring period provides an increasingly utilized research opportunity to study human neurophysiology, however ethical concerns demand a thorough appreciation of the associated risks. We measured the incidence of research stimulation-associated seizures in a large multi-institutional dataset in order to determine whether brain stimulation was statistically associated with seizure incidence and identify potential risk factors for stimulation-associated seizures. 188 subjects undergoing iEEG monitoring across ten institutions participated in 770 research stimulation sessions over 3.5 yr. Seizures within 30 min of a stimulation session were included in our retrospective analysis. We analyzed stimulation parameters, seizure incidence, and typical seizure patterns, to assess the likelihood that recorded seizures were stimulation-induced, rather than events that occurred by chance in epilepsy patients prone to seizing. In total, 14 seizures were included in our analysis. All events were single seizures, and no adverse events occurred. The mean amplitude of seizure-associated stimulation did not differ significantly from the mean amplitude delivered in sessions without seizures. In order to determine the likelihood that seizures were stimulation induced, we used three sets of analyses: visual iEEG analysis, statistical frequency, and power analyses. We determined that three of the 14 seizures were likely stimulation-induced, five were possibly stimulation-induced, and six were unlikely stimulation-induced. Overall, we estimate a rate of stimulation-induced seizures between 0.39% and 1.82% of sessions. The rarity of stimulation-associated seizures and the fact that none added morbidity or affected the clinical course of any patient are important findings for understanding the feasibility and safety of intracranial stimulation for research purposes.
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