Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT02236832
Status:
COMPLETED
Last Update Posted:
2025-09-04
First Post:
2014-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Neural Basis of Analogical Reasoning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057180', 'term': 'Frontotemporal Dementia'}, {'id': 'D013494', 'term': 'Supranuclear Palsy, Progressive'}], 'ancestors': [{'id': 'D057174', 'term': 'Frontotemporal Lobar Degeneration'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D009886', 'term': 'Ophthalmoplegia'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}, {'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2021-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2014-08-28', 'studyFirstSubmitQcDate': '2014-09-09', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance in the implicat task', 'timeFrame': 'day of inclusion (one day)', 'description': 'Reaction time and accuracy will be registered for this categorization task. This task will be used in patients with FTD and in healthy controls (n=60).\n\nParticipants will come only once during one day ot the research centre.'}, {'measure': 'Performance in the Similitude task', 'timeFrame': 'from inclusion to 4 months after inclusion', 'description': 'Reaction time and accuracy will be recorded while healthy subjects perform this categorization task, after a session of rTMS or during on line TMS (n=40).\n\nParticipants will come 3 to 5 times at the research centre in a maximum period of 4 months.'}], 'secondaryOutcomes': [{'measure': 'recording of EEG', 'timeFrame': 'day of inclusion (one day)', 'description': 'EEG will be recorded in patients with FTD and in healthy controls for an analysis of event related potentials.\n\nParticipants will come only once during one day a the research centre.'}, {'measure': 'Analysis of MRI', 'timeFrame': 'day of inclusion (one day)', 'description': 'T1 MRI will be recorded for VBM analysis in patients with FTD and healthy controls.\n\nParticipants will come only once during one day at the research centre'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Frontotemporal Dementia', 'Progressive Supranuclear Palsy', 'Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '34232829', 'type': 'BACKGROUND', 'citation': 'Ovando-Tellez M, Rohaut B, George N, Bieth T, Hugueville L, Ibrahim Y, Courbet O, Naccache L, Levy R, Garcin B, Volle E. Does adding <i>beer</i> to <i>coffee</i> enhance the activation of <i>drinks</i>? An ERP study of semantic category priming. Cogn Neurosci. 2022 Jan-Jun;13(2):61-76. doi: 10.1080/17588928.2021.1940117. Epub 2021 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'Frontal patients are impaired in categorisation and analogical reasoning tasks, and different functional imaging studies from our group have shown the involvement of the prefrontal cortex in categorisation and analogy tasks. The aim of this project is to test our hypotheses about the role of the prefrontal cortex in explicit and implicit categorisation and analogy tasks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy subjects:\n\n* subject affiliated to national health insurance\n* informed consent signed\n* normal neurological examination\n* subject aged at least 20\n\nPatients:\n\n* FTD or PSP diagnostic criteria filled\n* patient affiliated to national health insurance\n* informed consent signed\n\nExclusion Criteria:\n\n* Severe psychiatric symptomatology and psychotropic drug use\n* unability to understand or perform the cognitive tasks.'}, 'identificationModule': {'nctId': 'NCT02236832', 'acronym': 'ANALOG', 'briefTitle': 'Study of the Neural Basis of Analogical Reasoning', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': "Organisation du Cortex préfrontal ventrolatéral Pour l'Analogie: Approche Bimodale Chez le Sujet Sain et Chez le Patient Ayant un Syndrome Frontal.", 'orgStudyIdInfo': {'id': "C14-17'"}, 'secondaryIdInfos': [{'id': '140662B-31', 'type': 'OTHER', 'domain': 'ANSM (Agence Nationale de Sécurité du Médicament)'}, {'id': '2014-A00649-38', 'type': 'OTHER', 'domain': 'ANSM ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FTD (frontotemporal dementia) patients', 'description': 'fronto-temporal demential patients', 'interventionNames': ['Other: MRI imaging', 'Other: EEG recording', 'Behavioral: Neuropsychological examination']}, {'type': 'EXPERIMENTAL', 'label': 'PSP patients', 'description': 'progressive supra nuclear palsy patients', 'interventionNames': ['Other: MRI imaging', 'Other: EEG recording', 'Behavioral: Neuropsychological examination']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'healthy controls', 'description': 'healthy control education matched, age matched and sex matched with PSP and FTD patients', 'interventionNames': ['Other: MRI imaging', 'Other: EEG recording', 'Behavioral: Neuropsychological examination']}, {'type': 'EXPERIMENTAL', 'label': 'healthy participants', 'description': 'healthy participants that will participate to the TMS study.', 'interventionNames': ['Device: transcranial magnetic stimulation', 'Other: MRI imaging', 'Other: EEG recording', 'Behavioral: Neuropsychological examination']}, {'type': 'EXPERIMENTAL', 'label': 'healthy young participants', 'description': 'Healthy participants will be included for an EEG study', 'interventionNames': ['Other: EEG recording', 'Behavioral: Neuropsychological examination']}], 'interventions': [{'name': 'transcranial magnetic stimulation', 'type': 'DEVICE', 'armGroupLabels': ['healthy participants']}, {'name': 'MRI imaging', 'type': 'OTHER', 'armGroupLabels': ['FTD (frontotemporal dementia) patients', 'PSP patients', 'healthy controls', 'healthy participants']}, {'name': 'EEG recording', 'type': 'OTHER', 'armGroupLabels': ['FTD (frontotemporal dementia) patients', 'PSP patients', 'healthy controls', 'healthy participants', 'healthy young participants']}, {'name': 'Neuropsychological examination', 'type': 'BEHAVIORAL', 'armGroupLabels': ['FTD (frontotemporal dementia) patients', 'PSP patients', 'healthy controls', 'healthy participants', 'healthy young participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'ICM (Institut du cerveau et de la Moelle épinière)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Richard Levy, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut du Cerveau et de la Moelle épinière, Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD sharing will be only performed on individual request for a specified study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Fondation pour la Recherche Médicale', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}