- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02844374
Epileptogenic Zone's Cartography by Quantification of EEG's Signal and Intracerebral Stimulation. (EPISTIM)
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.
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Odotettu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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-
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La Tronche, Ranska, 38700
- Rekrytointi
- UniversityHospitalGrenoble
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Ottaa yhteyttä:
- Philippe Kahane, Professor
- Puhelinnumero: 04.76.76.54.48
- Sähköposti: philippe.kahane@ujf-grenoble.fr
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Ottaa yhteyttä:
- Lorella Minotti
- Puhelinnumero: 0476765448
- Sähköposti: Lminotti@chu-grenoble.fr
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Muut: 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.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Visual analysis
Aikaikkuna: up to one hour
|
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
Aikaikkuna: up to 10 min
|
Epileptogenic maps : calculated for each crisis and for all crisis in general.
|
up to 10 min
|
Connectivity maps
Aikaikkuna: up to 10 min
|
Connectivity maps : calculated for each site stimulated at low-frequency.
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up to 10 min
|
MRI
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Philippe Kahane, Professor, Grenoble Hospital University
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
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- 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.
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- 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.
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- 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.
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- 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.
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- 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.
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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.
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- 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.
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- 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.
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Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Odotettu)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 38RC14.079
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