Epileptogenic Zone's Cartography by Quantification of EEG's Signal and Intracerebral Stimulation. (EPISTIM)
25. juli 2016 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
45
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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La Tronche, Frankrig, 38700
- Rekruttering
- UniversityHospitalGrenoble
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Kontakt:
- Philippe Kahane, Professor
- Telefonnummer: 04.76.76.54.48
- E-mail: philippe.kahane@ujf-grenoble.fr
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Kontakt:
- Lorella Minotti
- Telefonnummer: 0476765448
- E-mail: Lminotti@chu-grenoble.fr
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
5 år til 65 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Andet: 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Visual analysis
Tidsramme: up to one hour
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Visual analysis : in order to define the level of cortical resections.
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up to one hour
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Epileptogenic maps
Tidsramme: up to 10 min
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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
Tidsramme: up to 10 min
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Connectivity maps : calculated for each site stimulated at low-frequency.
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up to 10 min
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MRI
Tidsramme: up to one hour
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Post-operative evaluation : in order to assess the extent of resection.
MRI : 3D-T1
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up to one hour
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Philippe Kahane, Professor, Grenoble Hospital University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- Tellez-Zenteno JF, Dhar R, Wiebe S. Long-term seizure outcomes following epilepsy surgery: a systematic review and meta-analysis. Brain. 2005 May;128(Pt 5):1188-98. doi: 10.1093/brain/awh449. Epub 2005 Mar 9.
- Alarcon G, Binnie CD, Elwes RD, Polkey CE. Power spectrum and intracranial EEG patterns at seizure onset in partial epilepsy. Electroencephalogr Clin Neurophysiol. 1995 May;94(5):326-37. doi: 10.1016/0013-4694(94)00286-t.
- 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.
- Bartolomei F, Chauvel P, Wendling F. Epileptogenicity of brain structures in human temporal lobe epilepsy: a quantified study from intracerebral EEG. Brain. 2008 Jul;131(Pt 7):1818-30. doi: 10.1093/brain/awn111. Epub 2008 Jun 13.
- Blauwblomme T, Kahane P, Minotti L, Grouiller F, Krainik A, Vercueil L, Chabardes S, Hoffmann D, David O. Multimodal imaging reveals the role of gamma activity in eating-reflex seizures. J Neurol Neurosurg Psychiatry. 2011 Oct;82(10):1171-3. doi: 10.1136/jnnp.2010.212696. Epub 2010 Nov 19.
- Bulacio JC, Jehi L, Wong C, Gonzalez-Martinez J, Kotagal P, Nair D, Najm I, Bingaman W. Long-term seizure outcome after resective surgery in patients evaluated with intracranial electrodes. Epilepsia. 2012 Oct;53(10):1722-30. doi: 10.1111/j.1528-1167.2012.03633.x. Epub 2012 Aug 20.
- Cossu M, Cardinale F, Castana L, Citterio A, Francione S, Tassi L, Benabid AL, Lo Russo G. Stereoelectroencephalography in the presurgical evaluation of focal epilepsy: a retrospective analysis of 215 procedures. Neurosurgery. 2005 Oct;57(4):706-18; discussion 706-18.
- Catenoix H, Magnin M, Guenot M, Isnard J, Mauguiere F, Ryvlin P. Hippocampal-orbitofrontal connectivity in human: an electrical stimulation study. Clin Neurophysiol. 2005 Aug;116(8):1779-84. doi: 10.1016/j.clinph.2005.03.016.
- Catenoix H, Magnin M, Mauguiere F, Ryvlin P. Evoked potential study of hippocampal efferent projections in the human brain. Clin Neurophysiol. 2011 Dec;122(12):2488-97. doi: 10.1016/j.clinph.2011.05.007. Epub 2011 Jun 12.
- David O, Bastin J, Chabardes S, Minotti L, Kahane P. Studying network mechanisms using intracranial stimulation in epileptic patients. Front Syst Neurosci. 2010 Oct 20;4:148. doi: 10.3389/fnsys.2010.00148. eCollection 2010.
- 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.
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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.
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- Nariai H, Nagasawa T, Juhasz C, Sood S, Chugani HT, Asano E. Statistical mapping of ictal high-frequency oscillations in epileptic spasms. Epilepsia. 2011 Jan;52(1):63-74. doi: 10.1111/j.1528-1167.2010.02786.x. Epub 2010 Nov 18.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2014
Primær færdiggørelse (Forventet)
1. januar 2017
Studieafslutning (Forventet)
1. januar 2017
Datoer for studieregistrering
Først indsendt
18. juli 2016
Først indsendt, der opfyldte QC-kriterier
25. juli 2016
Først opslået (Skøn)
26. juli 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. juli 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juli 2016
Sidst verificeret
1. juli 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 38RC14.079
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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