Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-30 @ 1:43 PM
Study NCT ID:
NCT03195803
Status:
COMPLETED
Last Update Posted:
2017-06-22
First Post:
2017-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Intervention in Mild Cognitive Impairment With or Without White Matter Hyperintensities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparison, non-randomized single blind study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-20', 'studyFirstSubmitDate': '2017-06-14', 'studyFirstSubmitQcDate': '2017-06-20', 'lastUpdatePostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rey Auditory Verbal Learning test', 'timeFrame': 'Baseline assessment, change from Baseline on Rey Auditory Verbal Learning test at 3 months immediately after intervention and at 3 months follow-up', 'description': 'Assessment of verbal learning in episodic memory'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'This is a non-pharmacological study evaluating the differential effects of a computerized cognitive stimulation program according to the existence or not of white matter hyperintensities in elderly with mild cognitive impairment.', 'detailedDescription': 'White matter hyperintensities (WMH) are increasingly recognized as a factor determining the heterogeneity of Mild Cognitive Impairment (MCI) and have been associated to executive and processing speed impairment. Cognitive interventions in MCI remain quite limited for these MCI with vascular profile and studies often distinguish patients by clinical subtypes rather than brain profile before an intervention. Considering magnetic resonance imaging (MRI) data, this study investigated the effects of a computer-based cognitive stimulation (CCS) program on MCI with WMH compared to MCI without WMH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Mild Cognitive Impairment\n* With and without white matter hyperintensities\n* MRI available or accept to perform one\n* No engagement in other cognitive intervention program\n\nExclusion Criteria:\n\n* Psychiatric and neurological disorders\n* History of alcohol or other substance abuse\n* Sensory and/or motor deficit affecting the use of a tablet'}, 'identificationModule': {'nctId': 'NCT03195803', 'briefTitle': 'Cognitive Intervention in Mild Cognitive Impairment With or Without White Matter Hyperintensities', 'organization': {'class': 'OTHER', 'fullName': 'Broca Hospital'}, 'officialTitle': 'Evaluation of Differential Effects of a Computer-based-cognitive Intervention on Cognition Among Elderly With Mild Cognitive Impairment With and Without White Matter Hyperintensities: A Comparative Study.', 'orgStudyIdInfo': {'id': 'LUS2WMH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MCI with WMH', 'description': 'Computerized Cognitive Stimulation was administered to this group, twice a week.', 'interventionNames': ['Behavioral: Computerized Cognitive Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MCI without WMH', 'description': 'Computerized Cognitive Stimulation was administered to this group, twice a week.', 'interventionNames': ['Behavioral: Computerized Cognitive Stimulation']}], 'interventions': [{'name': 'Computerized Cognitive Stimulation', 'type': 'BEHAVIORAL', 'description': 'All participants performed 12-week, 60-minutes twice a week of a computer-based cognitive stimulation program in group-setting, using a tablet with a software with specific training focused on attention, executive and speed processing functions.', 'armGroupLabels': ['MCI with WMH', 'MCI without WMH']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anne-Sophie AR RIGAUD, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Broca University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leila DJABELKHIR', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD candidate', 'investigatorFullName': 'Leila DJABELKHIR', 'investigatorAffiliation': 'Broca Hospital'}}}}