Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-02-17 @ 11:13 PM
Study NCT ID:
NCT01865357
Status:
COMPLETED
Last Update Posted:
2018-10-03
First Post:
2013-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Longitudinal 1-year Study of the Correlation Between Cognitive Functioning in Patients With Clinically Isolated Syndrome Suggestive of Multiple Sclerosis and Disconnection in the Brain Assessed by MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005133', 'term': 'Eye Movements'}], 'ancestors': [{'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D009799', 'term': 'Ocular Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-01', 'studyFirstSubmitDate': '2013-05-24', 'studyFirstSubmitQcDate': '2013-05-24', 'lastUpdatePostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between fractional anisotropy (FA) value and cognitive z scores or cognitive impairment indexes for each domains', 'timeFrame': 'visit 2 - 1 year after inclusion', 'description': 'IPS, attention, working memory, episodic memory and executive functions), established by voxel-wise statistics (TBSS) in CIS patients'}], 'secondaryOutcomes': [{'measure': 'Comparison of skeleton of FA between CIS patients and healthy subjects', 'timeFrame': 'V2 - 1 year after the inclusion'}, {'measure': 'Comparison of cognitive scores at each test between CIS patients and controls', 'timeFrame': 'D0 and V2 - 1 year after the inclusion'}, {'measure': 'Proportion of patients with cognitive impairment (≥ 3 tests impaired) and correlations with anxiety, depressive syndrome and fatigue', 'timeFrame': 'D0 and V2 - 1 year after the inclusion'}, {'measure': 'Comparison of statistical maps of FA', 'timeFrame': 'D0 and V2 - 1 year after the inclusion', 'description': 'mean cortical thickness and deep grey nuclei volumes with cognitive indexes in the 3 pre-define groups: cognitively preserved CIS patients at baseline and after one year; cognitively impaired CIS patients only after one year and cognitively impaired CIS patients at the two evaluations.'}, {'measure': 'Correlations between cognitive scores and mean cortical thickness and deep grey nuclei volumes in CIS patients', 'timeFrame': 'D0 and V2 - 1 year after the inclusion'}, {'measure': 'Comparison of cognitive scores at each test and eye movements scores', 'timeFrame': 'D0 and V2 - 1 year after the inclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Clinically Isolated Demyelinating Syndromes', 'Multiple Sclerosis', 'Cognitive Deficiencies', 'Brain MRI']}, 'referencesModule': {'references': [{'pmid': '27789541', 'type': 'DERIVED', 'citation': 'Moroso A, Ruet A, Lamargue-Hamel D, Munsch F, Deloire M, Coupe P, Ouallet JC, Planche V, Moscufo N, Meier DS, Tourdias T, Guttmann CR, Dousset V, Brochet B. Posterior lobules of the cerebellum and information processing speed at various stages of multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 Feb;88(2):146-151. doi: 10.1136/jnnp-2016-313867. Epub 2016 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'Clinically isolated demyelinating syndromes (CIS) can evolve into multiple sclerosis (MS). Cognitive deficiencies could occur at this early stage and concern mainly information processing speed (IPS) and their mechanisms are not fully understood. Diffusion Tensor Imaging (DTI) can help in the understanding of these mechanisms.', 'detailedDescription': 'This is a prospective cohort, observational, longitudinal, monocentric study. This study will include 60 patients with CIS followed for 1 year and 60 healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients:\n\n * Men and Women\n * ≥16 years\n * Fluent French speaker\n * Clinically isolated neurological syndrome (CIS) compatible with a demyelinating inflammatory episode within the central nervous system, potentially beginning multiple sclerosis (MS) whatever the mode of presentation\n * Between 60 and 180 days from the onset\n * At least two clinically silent lesions on their T2-weighted brain or spinal MRI scan with a size of at least 3 mm, at least one of which being cerebral, ovoid, or periventricular\n * Having a medical insurance\n * Free and informed consent signed\n* Controls:\n\n * Men and Women\n * ≥18 years\n * Fluent French speaker\n * Having a medical insurance\n * Free and informed consent signed\n\nExclusion Criteria:\n\n* Patients:\n\n * Prior documented neurological episode suggestive of MS.\n * Other ongoing neurological diseases.\n * Known chronic systemic diseases as judged by the investigator (for instance: lupus, Gougerot-Sjögren, sarcoidosis, sclerodermia, Crohn disease,…).\n * Other causes (trauma, tumor, radiotherapy, infections, vascular diseases, neuromyelitis optica).\n * Current dependence on alcohol or drugs.\n * Dosage change, stop or start of hypnotic or anxiolytic or antidepressive treatment less than 15 days\n * MRI contra-indications.\n * Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily.\n* Controls:\n\n * Known chronic psychiatric or neurologic diseases which could interfere with neuropsychological testing, not taking into account stable and mild depressive syndrome\n * Known chronic systemic diseases as judged by the investigator (for instance: lupus, Gougerot-Sjögren, sarcoidosis, scleroderma, Crohn disease…).\n * MS familial history\n * Current dependence on alcohol or drugs\n * Known cognitive impairment\n * Prior neuropsychological testing with the same tests less than one year\n * Dosage change, stop or start of hypnotic or anxiolytic or antidepressive treatment less than 2 months\n * Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily.\n * MRI contra-indications\n * Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily.'}, 'identificationModule': {'nctId': 'NCT01865357', 'acronym': 'SCI-COG', 'briefTitle': 'Prospective Longitudinal 1-year Study of the Correlation Between Cognitive Functioning in Patients With Clinically Isolated Syndrome Suggestive of Multiple Sclerosis and Disconnection in the Brain Assessed by MRI', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Prospective Longitudinal 1-year Study of the Correlation Between Cognitive Functioning in Patients With Clinically Isolated Syndrome Suggestive of Multiple Sclerosis and Disconnection in the Brain Assessed by MRI:"SCI-COG" Study', 'orgStudyIdInfo': {'id': 'CHUBX 2011/33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient', 'description': 'Clinically isolated neurological syndrome (CIS) compatible with a demyelinating inflammatory episode within the central nervous system, potentially beginning multiple sclerosis (MS) whatever the mode of presentation', 'interventionNames': ['Other: Brain MRI - Clinical and cognitive evaluation', 'Other: Eye movement']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'healthy subject', 'interventionNames': ['Other: Brain MRI - Clinical and cognitive evaluation', 'Other: Eye movement']}], 'interventions': [{'name': 'Brain MRI - Clinical and cognitive evaluation', 'type': 'OTHER', 'description': '* Clinical evaluation (EDSS, MSFC)\n* Cognitive evaluation with tests of information processing speed, attention, working memory, episodic memory and executive functions, assessment of confounding factors (depression (BDI) and anxiety (HAD), mood (EHD), fatigue (M-FIS) and assessment of quality of life (SEP-59)\n* Brain MRI (3 Tesla): FLAIR, 3D MPRAGE T1 and DTI', 'armGroupLabels': ['Control', 'Patient']}, {'name': 'Eye movement', 'type': 'OTHER', 'description': 'Assessment of eye Movements (EyeBrain software) for only the group of 15 healthy subjects at baseline and at 12 months', 'armGroupLabels': ['Control', 'Patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Bruno BROCHET, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'TEVA laboratories', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}