Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-01-18 @ 4:36 PM
Study NCT ID:
NCT02391493
Status:
COMPLETED
Last Update Posted:
2018-03-27
First Post:
2015-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neural Correlates of Language Control in Bilinguals. Functional MRI and Stimulation Mapping Data in Awake Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-25', 'studyFirstSubmitDate': '2015-03-04', 'studyFirstSubmitQcDate': '2015-03-17', 'lastUpdatePostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain activity', 'timeFrame': '24 hours', 'description': 'The primary judgment criteria is brain activity as measured by functional magnetic resonance imaging :\n\n* In blocked vs. switched naming in control subjects\n* In switched naming in early vs. late bilingual subjects\n* In blocked vs. switched naming in early vs. late bilingual subjects'}], 'secondaryOutcomes': [{'measure': 'Brain activity', 'timeFrame': '24 hours', 'description': 'The secondary judgment criteria is brain activity measured by functional magnetic resonance imaging :\n\n* In blocked vs. switched naming in the patients\n* In French vs. English and English vs. French naming in the late bilinguals\n* In French vs. English and English vs. French naming in the early bilinguals\n* In French vs. LX and LX vs. French naming in the patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bilinguals', 'language control', 'executive functions', 'functional MRI', 'stimulation mapping', 'brain tumors'], 'conditions': ['Bilingualism']}, 'descriptionModule': {'briefSummary': 'For bilingual and multilingual patients, brain activation and Electric Stimulation Mapping studies have shown that different languages may be localized, at least partially, in distinct microanatomical systems located within the same gross anatomical areas.\n\nThe present investigation involves both types of healthy bilinguals with carefully controlled proficiency levels, as well as bilingual patients suffering from low-grade glioma.\n\nFunctional magnetic resonance imaging data will be collected while the participants perform a picture naming task in blocked conditions for both languages (either English or French) or in switch condition (English and French). A stimulation mapping study will be conducted in the patients during awake surgery with the same tasks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients:\n\n* Bilingual patients with a pathology indicating an intervention in awake surgery (e.g. low-grade glioma)\n* At least C1-level of the CECR in both languages\n* At least 12 years of schooling (French BAC)\n* Right-handed (Edinburgh test, 1971)\n* Performance indicator Eastern Cooperative Oncology Group 0-2 (cf. annexe)\n* Life expectation \\> 6 month\n* Affiliated to social insurance\n* Having given informed consent\n\nHealthy volunteers:\n\n* French-English or English-French bilinguals with at least a C1 level (CECR) in both languages\n* At least 12 years of schooling (French BAC)\n* Right-handed (Edinburgh test, 1971)\n* Early bilinguals: age of acquisition of both languages \\< 3 years\n* Late bilinguals: age of acquisition of the L2 \\> 10 years\n\nExclusion Criteria:\n\nPatients:\n\n* Contra-indication for MRI\n* Left-handed or ambidexter (less than +80 at the Edinburgh test - 1971)\n* Mini-Mental State Examination \\<26\n* Patient who cannot respect the procedures, visits, exams described in the protocol\n* Any other medical or psychiatric affection which renders inclusion of the patient to the study inappropriate as judged by the principal investigator\n\nHealthy volunteers:\n\n* Contra-indication for MRI\n* Mini-Mental State Examination \\< 26\n* Age of acquisition of one of the language between 3 and 10 years'}, 'identificationModule': {'nctId': 'NCT02391493', 'acronym': 'NEUROSWITCH', 'briefTitle': 'Neural Correlates of Language Control in Bilinguals. Functional MRI and Stimulation Mapping Data in Awake Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Neural Correlates of Language Control in Bilinguals. Functional MRI and Stimulation Mapping Data in Awake Surgery. (NEUROSWITCH)', 'orgStudyIdInfo': {'id': '13 245 03'}, 'secondaryIdInfos': [{'id': 'HAO 2013', 'type': 'OTHER_GRANT', 'domain': "Maison des sciences de l'homme de Toulouse"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'healthy early bilinguals', 'description': 'healthy early bilinguals functional magnetic resonance imaging', 'interventionNames': ['Device: functional magnetic resonance imaging']}, {'type': 'EXPERIMENTAL', 'label': 'healthy late bilinguals', 'description': 'healthy late bilinguals functional magnetic resonance imaging', 'interventionNames': ['Device: functional magnetic resonance imaging']}, {'type': 'EXPERIMENTAL', 'label': 'bilingual patients', 'description': 'bilingual patients suffering from low-grade glioma in the language areas functional magnetic resonance imaging', 'interventionNames': ['Device: functional magnetic resonance imaging']}], 'interventions': [{'name': 'functional magnetic resonance imaging', 'type': 'DEVICE', 'description': 'Stimuli will be presented in 3 language conditions, French, English and "switch" in which the participant alternates between English and French every trial. A block design will be used, with 7 line drawings per language condition. Four 9-minute runs will be performed, there being 2 action runs and 2 object runs. In each run, there are 6 blocks of each language condition, presented in a fixed random order. No drawings are repeated. Each stimulus is preceded either by an English or a French prompt word ("to" or "faire" for actions and, "say" or "dire" for objects) for 450 msec; stimuli are presented for 1.5 seconds and followed by a blank screen for 1 second. Language blocks are separated by a variable duration (from 8 to 10 seconds).', 'armGroupLabels': ['bilingual patients', 'healthy early bilinguals', 'healthy late bilinguals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'University Hospital of Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Vincent LUBRANO, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}