Epileptogenic Zone's Cartography by Quantification of EEG's Signal and Intracerebral Stimulation. (EPISTIM)
2016年7月25日 更新者：University Hospital, Grenoble
Epilepsy is a devastating chronic disease due to multiple causes that affect close to 50% of the world's population.
Although effective, epilepsy surgery fails in many cases, the percentage of patients free from crisis on a long term (≥ 5 years) varies from 27% to 66% according to the kind of epilepsy.
It is in this context that EPISTIM is interesting, and its aims isb a better electrophysiology delimiting of cortical networks that imply the genesis of seizures with the aim to improove surgery results.
This study will rely on the intracerebral records and on corticales electrical stimulation as they are currently routinely used by epileptic patients candidates for surgery.
研究概览
研究类型
介入性
注册 (预期的)
45
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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La Tronche、法国、38700
- 招聘中
- UniversityHospitalGrenoble
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接触：
- Philippe Kahane, Professor
- 电话号码：04.76.76.54.48
- 邮箱：philippe.kahane@ujf-grenoble.fr
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接触：
- Lorella Minotti
- 电话号码：0476765448
- 邮箱：Lminotti@chu-grenoble.fr
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
5年 至 65年 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria :
- Patient from 5 to 65 years (L1121-7 L1122 2 CSP), including legally protected or unable to give his consent (L1121-8 CSP).
- Written approval of inclusion in the study from the patient or his legal representative.
- Patients with partial Epilepsy Drug Resistant , justifying a SEEG exploration.
Exclusion Criteria :
- Patient under 5 years.
- Patient over 65 years.
- Pregnant or breastfeeeding women (L1121-5 CSP).
- Patient deprived of liberty as a result of a judicial or administrative decision (L1121-6 CSP).
- Patients over 18 years unable to give their free consent and not subject to a legal protection order.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Partial Epilepsy Drug Resistant
Patients with partial Epilepsy Drug Resistant , justifying a SEEG exploration.
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Visual analysis : in order to define the level of cortical resections.
Epileptogenic maps : calculated for each crisis and for all crisis in general.
Connectivity maps : calculated for each site stimulated at low-frequency.
Post-operative evaluation : in order to assess the extent of resection.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Visual analysis
大体时间：up to one hour
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Visual analysis : in order to define the level of cortical resections.
|
up to one hour
|
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Epileptogenic maps
大体时间：up to 10 min
|
Epileptogenic maps : calculated for each crisis and for all crisis in general.
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up to 10 min
|
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Connectivity maps
大体时间：up to 10 min
|
Connectivity maps : calculated for each site stimulated at low-frequency.
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up to 10 min
|
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MRI
大体时间：up to one hour
|
Post-operative evaluation : in order to assess the extent of resection.
MRI : 3D-T1
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up to one hour
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Philippe Kahane, Professor、Grenoble Hospital University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Allen PJ, Fish DR, Smith SJ. Very high-frequency rhythmic activity during SEEG suppression in frontal lobe epilepsy. Electroencephalogr Clin Neurophysiol. 1992 Feb;82(2):155-9. doi: 10.1016/0013-4694(92)90160-j.
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- David O, Blauwblomme T, Job AS, Chabardes S, Hoffmann D, Minotti L, Kahane P. Imaging the seizure onset zone with stereo-electroencephalography. Brain. 2011 Oct;134(Pt 10):2898-911. doi: 10.1093/brain/awr238.
- Engel J Jr, Van Ness Paul C, Rasmussen TB, Ojemann LM. Outcome with respect to epileptic seizures. In: Engel J Jr, editor. Surgical treatment of the epilepsies, 2d ed. Philadelphia: Lippincott-Raven; 1996: 609-621.
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- Gordon B, Lesser RP, Rance NE, Hart J Jr, Webber R, Uematsu S, Fisher RS. Parameters for direct cortical electrical stimulation in the human: histopathologic confirmation. Electroencephalogr Clin Neurophysiol. 1990 May;75(5):371-7. doi: 10.1016/0013-4694(90)90082-u.
- Jallon P. [Epidemiology of drug-resistant epilepsies]. Rev Neurol (Paris). 2004 Jun;160 Spec No 1:5S22-30. French.
- Jirsch JD, Urrestarazu E, LeVan P, Olivier A, Dubeau F, Gotman J. High-frequency oscillations during human focal seizures. Brain. 2006 Jun;129(Pt 6):1593-608. doi: 10.1093/brain/awl085. Epub 2006 Apr 21.
- Kahane P, Bartolomei F. Traitement neurochirurgical de l'épilepsie. EMC (Elsevier Masson SAS, Paris), Neurologie, 17-045-A-53, 2011.
- Kahane P, Tassi L, Francione S, Hoffmann D, Lo Russo G, Munari C. [Electroclinical manifestations elicited by intracerebral electric stimulation "shocks" in temporal lobe epilepsy]. Neurophysiol Clin. 1993 Jul;23(4):305-26. doi: 10.1016/s0987-7053(05)80123-6. French.
- Kahane P, Minotti L, Hoffmann D, Lachaux JP, Ryvlin P. Invasive EEG in the definition of the seizure onset zone: depth electrodes. In : Rosenow F, Lüders HO, eds. Handbook of Clinical Neurophysiology, Vol.3. Presurgical assessment of the epilepsies with clinical neurophysiology and functional imaging. Amsterdam : Elsevier BV, 2004 : 109-133.
- Kahane P, Ryvlin P, Vercueil L, Hirsch E, Arzimanoglou A. [In this era of value for money what is the place of epilepsy surgery in hospital practice]. Rev Neurol (Paris). 2007 Dec;163(12):1151-6. doi: 10.1016/S0035-3787(07)78399-6. No abstract available. French.
- Koubeissi MZ, Lesser RP, Sinai A, Gaillard WD, Franaszczuk PJ, Crone NE. Connectivity between perisylvian and bilateral basal temporal cortices. Cereb Cortex. 2012 Apr;22(4):918-25. doi: 10.1093/cercor/bhr163. Epub 2011 Jun 29.
- Lacruz ME, Garcia Seoane JJ, Valentin A, Selway R, Alarcon G. Frontal and temporal functional connections of the living human brain. Eur J Neurosci. 2007 Sep;26(5):1357-70. doi: 10.1111/j.1460-9568.2007.05730.x.
- Lee SA, Spencer DD, Spencer SS. Intracranial EEG seizure-onset patterns in neocortical epilepsy. Epilepsia. 2000 Mar;41(3):297-307. doi: 10.1111/j.1528-1157.2000.tb00159.x.
- Matsumoto R, Nair DR, LaPresto E, Najm I, Bingaman W, Shibasaki H, Luders HO. Functional connectivity in the human language system: a cortico-cortical evoked potential study. Brain. 2004 Oct;127(Pt 10):2316-30. doi: 10.1093/brain/awh246. Epub 2004 Jul 21.
- Matsumoto R, Nair DR, LaPresto E, Bingaman W, Shibasaki H, Luders HO. Functional connectivity in human cortical motor system: a cortico-cortical evoked potential study. Brain. 2007 Jan;130(Pt 1):181-97. doi: 10.1093/brain/awl257. Epub 2006 Oct 17.
- Matsumoto R, Nair DR, Ikeda A, Fumuro T, Lapresto E, Mikuni N, Bingaman W, Miyamoto S, Fukuyama H, Takahashi R, Najm I, Shibasaki H, Luders HO. Parieto-frontal network in humans studied by cortico-cortical evoked potential. Hum Brain Mapp. 2012 Dec;33(12):2856-72. doi: 10.1002/hbm.21407. Epub 2011 Sep 19.
- Morris H, Najm I, Kahane P. Epilepsy surgery : patient selection. In: Lüders HO, ed. Textbook of epilepsy surgery. London : Informa Healthcare, 2008: 230-237.
- Munari C, Bancaud J. The role of stereo-electro-encephalography (SEEG) in the evaluation of partial epileptic patients. In: Porter RJ, Morselli PL, eds. The epilepsies. London : Butterworths, 1987 : 267-306.
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- Nathan SS, Sinha SR, Gordon B, Lesser RP, Thakor NV. Determination of current density distributions generated by electrical stimulation of the human cerebral cortex. Electroencephalogr Clin Neurophysiol. 1993 Mar;86(3):183-92. doi: 10.1016/0013-4694(93)90006-h.
- Ochi A, Otsubo H, Donner EJ, Elliott I, Iwata R, Funaki T, Akizuki Y, Akiyama T, Imai K, Rutka JT, Snead OC 3rd. Dynamic changes of ictal high-frequency oscillations in neocortical epilepsy: using multiple band frequency analysis. Epilepsia. 2007 Feb;48(2):286-96. doi: 10.1111/j.1528-1167.2007.00923.x.
- Penfield W, Jasper H, eds. Epilepsy and the functional anatomy of the human brain. Boston: Little, Brown and Company, 1954.
- Picot MC, Baldy-Moulinier M, Daures JP, Dujols P, Crespel A. The prevalence of epilepsy and pharmacoresistant epilepsy in adults: a population-based study in a Western European country. Epilepsia. 2008 Jul;49(7):1230-8. doi: 10.1111/j.1528-1167.2008.01579.x.
- Rosenberg DS, Mauguiere F, Catenoix H, Faillenot I, Magnin M. Reciprocal thalamocortical connectivity of the medial pulvinar: a depth stimulation and evoked potential study in human brain. Cereb Cortex. 2009 Jun;19(6):1462-73. doi: 10.1093/cercor/bhn185. Epub 2008 Oct 20.
- Schmidt D, Baumgartner C, Loscher W. The chance of cure following surgery for drug-resistant temporal lobe epilepsy. What do we know and do we need to revise our expectations? Epilepsy Res. 2004 Jul-Aug;60(2-3):187-201. doi: 10.1016/j.eplepsyres.2004.07.004.
- Valentin A, Anderson M, Alarcon G, Seoane JJ, Selway R, Binnie CD, Polkey CE. Responses to single pulse electrical stimulation identify epileptogenesis in the human brain in vivo. Brain. 2002 Aug;125(Pt 8):1709-18. doi: 10.1093/brain/awf187.
- Wendling F, Bartolomei F, Bellanger JJ, Bourien J, Chauvel P. Epileptic fast intracerebral EEG activity: evidence for spatial decorrelation at seizure onset. Brain. 2003 Jun;126(Pt 6):1449-59. doi: 10.1093/brain/awg144.
- Wilson CL, Isokawa M, Babb TL, Crandall PH. Functional connections in the human temporal lobe. I. Analysis of limbic system pathways using neuronal responses evoked by electrical stimulation. Exp Brain Res. 1990;82(2):279-92. doi: 10.1007/BF00231248.
- Worrell GA, Parish L, Cranstoun SD, Jonas R, Baltuch G, Litt B. High-frequency oscillations and seizure generation in neocortical epilepsy. Brain. 2004 Jul;127(Pt 7):1496-506. doi: 10.1093/brain/awh149. Epub 2004 May 20.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年1月1日
初级完成 (预期的)
2017年1月1日
研究完成 (预期的)
2017年1月1日
研究注册日期
首次提交
2016年7月18日
首先提交符合 QC 标准的
2016年7月25日
首次发布 (估计)
2016年7月26日
研究记录更新
最后更新发布 (估计)
2016年7月26日
上次提交的符合 QC 标准的更新
2016年7月25日
最后验证
2016年7月1日
更多信息
与本研究相关的术语
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.