Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-02-13 @ 10:27 AM
Study NCT ID:
NCT02577757
Status:
UNKNOWN
Last Update Posted:
2015-10-16
First Post:
2015-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing the Language Network With Independent Component Analysis of Resting State MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007802', 'term': 'Language'}], 'ancestors': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '2015-09-18', 'studyFirstSubmitQcDate': '2015-10-13', 'lastUpdatePostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI data obtained by comparing a formal language test to data obtained by a session of rest independent component analyzed in patients and volunteers', 'timeFrame': '1 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Languages network', 'Functional MRI'], 'conditions': ['Languages']}, 'descriptionModule': {'briefSummary': 'Proceed to an analysis of sensitivity and specificity results of the fMRI language network obtained in two ways: by providing a conventional language test and independent component analysis. These two methods will be compared to the reference method what the cortical intraoperative mapping.', 'detailedDescription': 'Patients with brain tumors including malignant gliomas located in eloquent areas have long been considered inoperable because of median survival and predictable postoperative sequelae. The improved prognosis with chemoradiotherapy and surgical resection as complete as possible questioned this attitude. The goal is to operate those patients without additional disabilities. The cortical electrostimulation intraoperative mapping in awake surgery can meet the eloquent areas. Identifying with fMRI these same areas to better specify in advance the way initially and shortened the time to awake exploratory surgery which improves patient comfort. However anxiety induced by the review in a pre-operative setting, a debutante aphasia often make problematic the realization of a formal language test. The analysis in the low frequency of spontaneous oscillations of large neuronal networks can help isolate network of language at rest without particular language test at the group analysis. This methodology, however, needs to be validated at the individual level before it can be applied to pathology.\n\nProceed to an analysis of sensitivity and specificity results of the fMRI language network obtained in two ways: by providing a conventional language test and independent component analysis. These two methods will be compared to the reference method what the cortical intraoperative mapping.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons major and minor.\n* Having given their written consent, or whose parents have given their written consent for minors.\n* Affiliated with the social security system\n* All patients eligible adults in awake surgery\n* Affiliated with the social security system\n* patient given their written consent\n\nExclusion Criteria\n\n* Contraindications to MRI\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT02577757', 'acronym': 'ICA Langage', 'briefTitle': 'Establishing the Language Network With Independent Component Analysis of Resting State MRI', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'orgStudyIdInfo': {'id': 'CHU-Promoteur 2012-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'healthy volunteers', 'description': 'achieving functional MRI', 'interventionNames': ['Device: MRI']}, {'type': 'EXPERIMENTAL', 'label': 'Eligible patients with awakened surgery', 'description': 'achieving functional MRI', 'interventionNames': ['Device: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'description': 'MRI', 'armGroupLabels': ['Eligible patients with awakened surgery', 'healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aram TER MINASSIAN, Physician', 'role': 'CONTACT', 'email': 'ArTerMinassian@chu-angers.fr', 'phone': '+33.2.41.35.52.31'}, {'name': 'Aram TER MINASSIAN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'centralContacts': [{'name': 'ARAM TER MINASSIAN, physician', 'role': 'CONTACT', 'email': 'ArTerMinassian@chu-angers.fr', 'phone': '+33.2.41.35.52.31'}], 'overallOfficials': [{'name': 'ARAM TER MINASSIAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH ANGERS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}