Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT03644732
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2018-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atlas of Human Cognition by SEEG (MAPCOG-SEEG)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069279', 'term': 'Drug Resistant Epilepsy'}, {'id': 'D004828', 'term': 'Epilepsies, Partial'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2030-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2018-04-09', 'studyFirstSubmitQcDate': '2018-08-21', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SEEG recordings using functional brain mapping procedure (composite measures)', 'timeFrame': '3 weeks', 'description': 'Prospective collection of data from SEEG recordings using functional brain mapping procedure performed in clinical routine during the presurgical assessment of patients with drug-resistant epilepsy. These data are represented by the electroencephalographic activity during the realization of the different cognitive tasks proposed to the patients. Electroencephalographic activity will then be analyzed in terms of Dynamic Spectral Imaging and in terms of high frequency activity (\\[50-150Hz\\]).'}], 'secondaryOutcomes': [{'measure': 'Behavioral data (composite measures)', 'timeFrame': '3 weeks', 'description': 'Behavioral data (reaction time and accuracy of response) collected during the presurgical assessment (joint with the SEEG) and during the postsurgical follow-up (approximately 3 months after the surgery) as well as the collection of neuropsychological scores from the presurgical and postsurgical assessment.\n\nBehavioral performance and neuropsychological test scores before and after surgery (as available) will allow to evaluate the impact of surgery on cognitive functioning (improvement or deterioration of cognitive performance).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognition'], 'conditions': ['Refractory Epilepsy', 'Focal Epilepsy']}, 'referencesModule': {'references': [{'pmid': '22750156', 'type': 'BACKGROUND', 'citation': 'Lachaux JP, Axmacher N, Mormann F, Halgren E, Crone NE. High-frequency neural activity and human cognition: past, present and possible future of intracranial EEG research. Prog Neurobiol. 2012 Sep;98(3):279-301. doi: 10.1016/j.pneurobio.2012.06.008. Epub 2012 Jun 26.'}, {'pmid': '25741734', 'type': 'RESULT', 'citation': 'Baciu M, Perrone-Bertolotti M. What do patients with epilepsy tell us about language dynamics? A review of fMRI studies. Rev Neurosci. 2015;26(3):323-41. doi: 10.1515/revneuro-2014-0074.'}, {'pmid': '27915117', 'type': 'RESULT', 'citation': 'Combrisson E, Perrone-Bertolotti M, Soto JL, Alamian G, Kahane P, Lachaux JP, Guillot A, Jerbi K. From intentions to actions: Neural oscillations encode motor processes through phase, amplitude and phase-amplitude coupling. Neuroimage. 2017 Feb 15;147:473-487. doi: 10.1016/j.neuroimage.2016.11.042. Epub 2016 Nov 30.'}, {'pmid': '22399764', 'type': 'RESULT', 'citation': 'Ossandon T, Vidal JR, Ciumas C, Jerbi K, Hamame CM, Dalal SS, Bertrand O, Minotti L, Kahane P, Lachaux JP. Efficient "pop-out" visual search elicits sustained broadband gamma activity in the dorsal attention network. J Neurosci. 2012 Mar 7;32(10):3414-21. doi: 10.1523/JNEUROSCI.6048-11.2012.'}, {'pmid': '24370818', 'type': 'RESULT', 'citation': 'Perrone-Bertolotti M, Vidal JR, de Palma L, Hamame CM, Ossandon T, Kahane P, Minotti L, Bertrand O, Lachaux JP. Turning visual shapes into sounds: early stages of reading acquisition revealed in the ventral occipitotemporal cortex. Neuroimage. 2014 Apr 15;90:298-307. doi: 10.1016/j.neuroimage.2013.12.027. Epub 2013 Dec 24.'}, {'pmid': '23223279', 'type': 'RESULT', 'citation': 'Perrone-Bertolotti M, Kujala J, Vidal JR, Hamame CM, Ossandon T, Bertrand O, Minotti L, Kahane P, Jerbi K, Lachaux JP. How silent is silent reading? Intracerebral evidence for top-down activation of temporal voice areas during reading. J Neurosci. 2012 Dec 5;32(49):17554-62. doi: 10.1523/JNEUROSCI.2982-12.2012.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of MAPCOG\\_SEEG is to create a database including brain recordings of cognition performed in clinical routine in patients during the pre-surgical SEEG assessment. This aims to be able to propose the first atlas of human cognition with a high temporal and spatial resolution.', 'detailedDescription': 'The pre-surgical assessment of a cortectomy in patient suffering from a refractory epilepsy includes several examinations aiming both, to specify the epileptogenic zone (EZ) which must be resected and to evaluate functional and cognitive risks of surgery.\n\nNevertheless, in some patients, non-invasive evaluation does not give formal answer. In these subjects, it is then necessary to carry out a second step, consisting of an invasive exploration by implantation of intracerebral electrodes during a Stereoelectroencephalography (SEEG).\n\nDue to its temporal and spatial resolution, the SEEG allows, besides the precise determination of the EZ, to carry out a functional mapping of the cortical regions likely to be included in cortectomy. Conventionally, this mapping is carried out on the basis of the cortical electrical stimulations applied to the implanted electrodes. If this approach is very robust for exploring primary functions such as motor skills or language, it cannot be used to evaluate more complex cognitive tasks such as face recognition or attention. Essential cognitive tasks on a daily basis.\n\nThis has led to the development in recent years, in Grenoble, of a complementary approach to cerebral stimulation: Dynamic Spectral Imaging (ISD). Numerous experimental paradigms have demonstrated that the realization of a cognitive task associates with the generation within the cortical regions involved in its treatment of a particular cortical activity. This activity is characterized by oscillations of the cortical rhythm in high frequencies (\\> 40 Hz), called gamma activities. The ISD thus consists in mapping this gamma activity during various cognitive tasks, thus making it possible to study more widely the complexity of the cognitive functions.\n\nMAPCOG\\_SEEG aims to collect the cerebral recording of the patients who have performed this cognitive exploration to be able to in fine propose an Atlas of human cognition which takes advantage of the very rich information in terms of spatial and temporal resolution of the SEEG. Furthermore, it will exactly allow more to understand the impact of the epilepsy and the surgery of the epilepsy on the cognition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult (Age between 18 and 65 years) patients receiving an SEEG exploration for presurgical evaluation of focal refractory epilepsy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Drug-resistant focal epilepsy\n* Justified SEEG exploration in the context of presurgical assessment of epilepsy\n* Written non-opposition to study participation\n* Intellectual capacities compatible with the compliance in the cognitive tasks\n\nExclusion Criteria:\n\n* Major Patient undergoing a legal protection measure or patient deprived of liberty as a result of a judicial or administrative decision\n* Impossibility of collecting information on exposure (recent arrival in France, foreign language, etc.)\n* Pregnant women (Contraindication to SEEG exploration)'}, 'identificationModule': {'nctId': 'NCT03644732', 'acronym': 'MAPCOG-SEEG', 'briefTitle': 'Atlas of Human Cognition by SEEG (MAPCOG-SEEG)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Atlas of Human Cognition by SEEG', 'orgStudyIdInfo': {'id': '38RC17.357'}, 'secondaryIdInfos': [{'id': '2017-A03248-45', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'SEEG Group', 'description': 'Group with SEEG analysis (Pre-surgical SEEG assessment)', 'interventionNames': ['Procedure: SEEG Group']}], 'interventions': [{'name': 'SEEG Group', 'type': 'PROCEDURE', 'description': 'Visual and quantitative SEEG signal analysis. As available, collection of behavioral and neuropsychological postsurgical data', 'armGroupLabels': ['SEEG Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe Kahane, MD/PhD', 'role': 'CONTACT', 'email': 'pkahane@chu-grenoble.fr', 'phone': '+33 476 765 488'}, {'name': 'Marcela Perrone-Bertolotti, PhD', 'role': 'CONTACT', 'email': 'marcela.perrone-bertolotti@univ-grenoble-alpes.fr', 'phone': '+33 476 825 860'}], 'facility': 'University Hospital, Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Louis MAILLARD', 'role': 'CONTACT', 'email': 'l.maillard@chru-nancy.fr'}], 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe DOMENECH', 'role': 'CONTACT', 'email': 'philippe.domenech@inserm.fr'}, {'name': 'Estelle Pruvost-Robieux', 'role': 'CONTACT', 'email': 'e.pruvost@ghu-paris.fr'}], 'facility': 'Hôpital Ste Anne', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anca NICA', 'role': 'CONTACT', 'email': 'Anca.NICA@chu-rennes.fr'}], 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'centralContacts': [{'name': 'Philippe Kahane, MD/PhD', 'role': 'CONTACT', 'email': 'pkahane@chu-grenoble.fr', 'phone': '+33 476 765 488'}, {'name': 'Marcela Perrone-Bertolotti, PhD', 'role': 'CONTACT', 'email': 'marcela.perrone-bertolotti@univ-grenoble-alpes.fr', 'phone': '+33 476 825 860'}], 'overallOfficials': [{'name': 'Philippe Kahane, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}, {'name': 'Marcela Perrone-Bertolotti, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centre National de la Recherche Scientifique, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}