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| Name | Class |
|---|---|
| Filadelfia Epilepsy Hospital | OTHER |
| Hospital del Mar | OTHER |
| Brno Epilepsy Center | UNKNOWN |
| University Hospital Bucharest (Adult) |
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Electrical source imaging is part of the presurgical evaluation of patients with drug-resistant focal epilepsy. The software packages that will be used in this study have Declaration of Conformity within the European Economic Area (CE mark) for this specific medical use. In spite of being part of the clinical standard, the evidence for the accuracy and clinical utility of these methods are derived from several smaller-scale and retrospective studies. The PROMAESIS study will provide solid evidence of the accuracy and clinical utility of automated ESI.
One-third of patients with epilepsy have seizures resistant to pharmacotherapy. There are many approaches developed to control these seizures, yet epilepsy surgery is still the most common method. The crucial part of epilepsy surgery is to assess the epileptic zone in order to render patients seizure free. However, accurate localization of the epileptic zone is often challenging due to the multimodal approach. This contains semiology, EEG (obtained during long term video-EEG monitoring), magnetic resonance Imaging (MRI), in addition to certain cases, positron emission computed tomography (PET), and single photon emission computed tomography (SPECT) and magnetoencephalography (MEG). At present, in one of the third patients, seizure remains after epilepsy surgery. Therefore a new preoperative method should be improved to assess the epileptic zone. Automated ESI is a post-processing novel method that estimates the location in the brain of the source of the recorded EEG signals.
The objective of this study is:
Methods:
Study design: a prospective diagnostic study in line with the Standards for Reporting Diagnostic Accuracy Studies (STARD).
EEG was recorded using the International Federation of Clinical Neurophysiology (IFCN) electrode array of 25 electrodes including six electrodes in the Inferior temporal chain (F9/10, T9/10, and P9/10) in addition to the 19 electrodes of the 10-20 system. Electrode impedance was kept below 5 kilo-ohm. EEG was recorded with a sampling frequency of 256 Hz. The investigators will make a video on how to place the electrodes, to make sure all centers follow a standardized method. Multidisciplinary epilepsy teams classify that in the first step you should keep the multidisciplinary team blinded to the source imaging data, and make the implantation plan without the ESI results. Then show the ESI, adjust the plan and note the changes.
The multidisciplinary teams in different centers will classify seizures into "types." A seizure type is a group of seizures that have stereotypical semiology and ictal EEG. Maximum 3 seizures are registered for per type. After Long Term Monitoring, they provide Epilog and Brain Electrical Source Analysis (BESA) teams with datasets including MRI and Long Term Monitoring recording for each patient. For uploading datasets, multicenter teams will use the platform developed by Epilog. Afterward, Epilog and BESA teams (blinded to patient information) will run the automated source imaging-both for interictal epileptiform discharge (EDs) and ictal signs. Both software packages have CE mark for ESI. Finally, the multidisciplinary teams take decisions in two steps:
I. Considering all data, except ESI II. Adding ESI to all other data.
At each step, the decisions are classified into one of the following categories:
In addition, the changes are classified into one of the following categories:
At one-year follow-up, the changes are categorized as useful or not useful. A change is defined useful as follows: (a) change from stop to Intracranial Recording: the Intracranial Recording localized the source; (b) change in implantation strategy: the electrode(s) implanted based on the source imaging identified the source; (c) change from implantation to operation: the patient became seizure-free.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No electrical source imaging (ESI) | Active Comparator | The multidisciplinary teams take decisions based on considering all data without ESI |
|
| Automated Electrical source imaging (ESI) | Experimental | The multidisciplinary teams take decisions based on considering all data with ESI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No electrical source imaging (ESI) | Diagnostic Test | For all patients: MRI, semiology, visual interpretation of EEG, and in selected cases, PET, SPECT |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Sensitivity and Specificity of automated ESI in presurgical evaluation. | For determining the the accuracy (sensitivity and specificity) of automated ESI, one year outcome after the operation will be calculated based on the defined criteria.
| 2 Years |
| the clinical utility of ESI in management of the patient with medically refractory epilepsy | For determining the clinical utility, the percentage of patients in whom automated ESI change decision on patients management will be calculated. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo Rocamora, MD | Hospital del Mar | Principal Investigator |
| Martin Pali, MD | Brno Epilepsy Center | Principal Investigator |
| Ioana Mindruta, MD | University Hospital Bucharest (Adult) | Principal Investigator |
| Andreas Schulze Bonhage, MD | Freiburg University | Principal Investigator |
| Tim von Oertzen, MD | Kepler University Clinic, Linz | Principal Investigator |
| Vdym Gnatkovsky, MD | Carlo Besta Institure, Milano | Principal Investigator |
| Peter Marusic, MD | Motol University Hospital | Principal Investigator |
| Markus Leitinger, MD | Christian Doppler Klinik, Salzburg | Principal Investigator |
| Francisco Sales, MD | Unidade Local de SaĂşde de Coimbra, EPE | Principal Investigator |
| vicente villanueva, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kepler University Clinic | Linz | Austria | ||||
| Christian Doppler Klinik |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12477991 | Background | Boon P, D'Have M, Vanrumste B, Van Hoey G, Vonck K, Van Walleghem P, Caemaert J, Achten E, De Reuck J. Ictal source localization in presurgical patients with refractory epilepsy. J Clin Neurophysiol. 2002 Oct;19(5):461-8. doi: 10.1097/00004691-200210000-00009. | |
| 21975586 | Background | Brodbeck V, Spinelli L, Lascano AM, Wissmeier M, Vargas MI, Vulliemoz S, Pollo C, Schaller K, Michel CM, Seeck M. Electroencephalographic source imaging: a prospective study of 152 operated epileptic patients. Brain. 2011 Oct;134(Pt 10):2887-97. doi: 10.1093/brain/awr243. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2018 | Jan 11, 2020 |
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| UNKNOWN |
| Freiburg University | UNKNOWN |
| Kepler University Clinic, Linz | UNKNOWN |
| Motol University Hospital | OTHER |
| Christian Doppler Klinik, Salzburg | UNKNOWN |
| Unidade Local de SaĂşde de Coimbra, EPE | OTHER |
| Hospital ClĂnico Universitario de Valencia | OTHER |
| Carlo Besta Institure, Milano | UNKNOWN |
| Hospital de Santa Maria, Lisbon | UNKNOWN |
Evaluation of automated electrical source imaging(ESI) in epilepsy surgery.
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| Automated electrical source imaging (ESI) | Diagnostic Test | The automated source imaging consists of 2 phases
|
|
| Hospital ClĂnico Universitario de Valencia |
| Principal Investigator |
| Carla Bente, MD | Hospital de Santa Maria, | Principal Investigator |
| Salzburg |
| Austria |
| Motol University Hospital | Prague | Czech Rebuplic | Czechia |
| Brno Epilepsy Center | Brno | Czech Republic | Czechia |
| Danish Epilepsy Center | Dianalund | DK 4293 | Denmark |
| Freiburg University | Freiburg im Breisgau | Baden-Wurttemberg | Germany |
| Carlo Besta Institure | Milan | Italy |
| Valencia University Hospital | Venice | Italy |
| Centro Hospitalar e Universitário de Coimbra | Coimbra | Portugal |
| Hospital de Santa Maria | Lisbon | Portugal |
| University Hospital Bucharest | Bucharest | Romania |
| Hospital del Mar | Barcelona | 08003 | Spain |
| 23944234 | Background | Beniczky S, Lantz G, Rosenzweig I, Akeson P, Pedersen B, Pinborg LH, Ziebell M, Jespersen B, Fuglsang-Frederiksen A. Source localization of rhythmic ictal EEG activity: a study of diagnostic accuracy following STARD criteria. Epilepsia. 2013 Oct;54(10):1743-52. doi: 10.1111/epi.12339. Epub 2013 Aug 14. |
| 23899624 | Background | Megevand P, Spinelli L, Genetti M, Brodbeck V, Momjian S, Schaller K, Michel CM, Vulliemoz S, Seeck M. Electric source imaging of interictal activity accurately localises the seizure onset zone. J Neurol Neurosurg Psychiatry. 2014 Jan;85(1):38-43. doi: 10.1136/jnnp-2013-305515. Epub 2013 Jul 30. |
| 24702598 | Background | Rikir E, Koessler L, Gavaret M, Bartolomei F, Colnat-Coulbois S, Vignal JP, Vespignani H, Ramantani G, Maillard LG. Electrical source imaging in cortical malformation-related epilepsy: a prospective EEG-SEEG concordance study. Epilepsia. 2014 Jun;55(6):918-32. doi: 10.1111/epi.12591. Epub 2014 Apr 4. |
| 26021550 | Background | Lascano AM, Perneger T, Vulliemoz S, Spinelli L, Garibotto V, Korff CM, Vargas MI, Michel CM, Seeck M. Yield of MRI, high-density electric source imaging (HD-ESI), SPECT and PET in epilepsy surgery candidates. Clin Neurophysiol. 2016 Jan;127(1):150-155. doi: 10.1016/j.clinph.2015.03.025. Epub 2015 May 9. |
| 26818882 | Background | Maliia MD, Meritam P, Scherg M, Fabricius M, Rubboli G, Mindruta I, Beniczky S. Epileptiform discharge propagation: Analyzing spikes from the onset to the peak. Clin Neurophysiol. 2016 Apr;127(4):2127-33. doi: 10.1016/j.clinph.2015.12.021. Epub 2016 Jan 12. |
| 27012361 | Background | Mouthaan BE, Rados M, Barsi P, Boon P, Carmichael DW, Carrette E, Craiu D, Cross JH, Diehl B, Dimova P, Fabo D, Francione S, Gaskin V, Gil-Nagel A, Grigoreva E, Guekht A, Hirsch E, Hecimovic H, Helmstaedter C, Jung J, Kalviainen R, Kelemen A, Kimiskidis V, Kobulashvili T, Krsek P, Kuchukhidze G, Larsson PG, Leitinger M, Lossius MI, Luzin R, Malmgren K, Mameniskiene R, Marusic P, Metin B, Ozkara C, Pecina H, Quesada CM, Rugg-Gunn F, Rydenhag B, Ryvlin P, Scholly J, Seeck M, Staack AM, Steinhoff BJ, Stepanov V, Tarta-Arsene O, Trinka E, Uzan M, Vogt VL, Vos SB, Vulliemoz S, Huiskamp G, Leijten FS, Van Eijsden P, Braun KP; E-PILEPSY consortium. Current use of imaging and electromagnetic source localization procedures in epilepsy surgery centers across Europe. Epilepsia. 2016 May;57(5):770-6. doi: 10.1111/epi.13347. Epub 2016 Mar 25. |
| Prot_001.pdf |
| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007154 | Immune System Diseases |
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