Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-03-29 @ 2:00 AM
Study NCT ID:
NCT02384057
Status:
COMPLETED
Last Update Posted:
2018-03-06
First Post:
2015-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Rehabilitation With C8 Sciences
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-05', 'studyFirstSubmitDate': '2015-02-23', 'studyFirstSubmitQcDate': '2015-03-04', 'lastUpdatePostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline Cambridge Neuropsychological Test Automated Battery(CANTAB) Spatial working memory at 34 th intervention', 'timeFrame': 'Baseline, 34th day from baseline'}, {'measure': 'Change from baseline CANTAB Rapid Visual information Processing at 34 th intervention', 'timeFrame': 'Baseline, 34th day from baseline'}], 'secondaryOutcomes': [{'measure': 'CANTAB Spatial working memory', 'timeFrame': 'Baseline, 34th day from baseline, 64th day from baseline'}, {'measure': 'CANTAB Rapid Visual information Processing', 'timeFrame': 'Baseline, 34th day from baseline, 64th day from baseline'}, {'measure': 'CANTAB Motor control task', 'timeFrame': 'Baseline, 34th day from baseline, 64th day from baseline'}, {'measure': 'CANTAB Paired Associated Learning', 'timeFrame': 'Baseline, 34th day from baseline, 64th day from baseline'}, {'measure': 'CANTAB reaction time', 'timeFrame': 'Baseline, 34th day from baseline, 64th day from baseline'}, {'measure': 'CANTAB Attention Switching Task', 'timeFrame': 'Baseline, 34th day from baseline, 64th day from baseline'}, {'measure': 'CANTAB Stoking of Cambridge', 'timeFrame': 'Baseline, 34th day from baseline, 64th day from baseline'}, {'measure': 'CANTAB Emotion Recognition Task', 'timeFrame': 'Baseline, 34th day from baseline, 64th day from baseline'}, {'measure': 'CANTAB Stop Signal Task', 'timeFrame': 'Baseline, 34th day from baseline, 64th day from baseline'}, {'measure': 'Geriatric depression scale', 'timeFrame': 'Baseline, 34th day from baseline', 'description': 'Older participants'}, {'measure': 'Beck depression index', 'timeFrame': 'Baseline, 34th day from baseline'}, {'measure': 'Korean Mini-Mental State Examination (K-MMSE)', 'timeFrame': 'Baseline, 34th day from baseline'}, {'measure': 'Korean activities of daily living (K-ADL)', 'timeFrame': 'Baseline, 34th day from baseline, 64th day from baseline'}, {'measure': 'Korean instrumental activities of daily living (K-IADL)', 'timeFrame': 'Baseline, 34th day from baseline, 64th day from baseline'}, {'measure': 'clinical dementia rating scale (CDR)', 'timeFrame': 'Baseline, 34th day from baseline'}, {'measure': 'Stroke impact scale', 'timeFrame': 'Baseline, 34th day from baseline'}, {'measure': 'Subjective memory complaint questionnaire', 'timeFrame': 'Baseline, 34th day from baseline, 64th day from baseline'}, {'measure': 'NIH toolbox', 'timeFrame': 'Baseline, 17th day from baseline, 34th day from baseline, 64th day from baseline'}, {'measure': 'Autobiographical memory', 'timeFrame': 'Baseline, 34th day from baseline'}, {'measure': 'Trail making test (A/B)', 'timeFrame': 'Baseline, 34th day from baseline, 64th day from baseline'}, {'measure': 'Trail making test - Black and White', 'timeFrame': 'Baseline, 34th day from baseline, 64th day from baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stroke', 'Brain Injuries']}, 'referencesModule': {'references': [{'pmid': '35349186', 'type': 'DERIVED', 'citation': 'Gibson E, Koh CL, Eames S, Bennett S, Scott AM, Hoffmann TC. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD006430. doi: 10.1002/14651858.CD006430.pub3.'}]}, 'descriptionModule': {'briefSummary': 'C8 sciences program is a cognitive training program mainly developed for the students, and the effectiveness is well established. The aim of this trial is to assess clinical efficacy of the program for cognitive rehabilitation of the patients with stroke or brain injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with stroke or brain injury\n* Cognitive deficits\n\nExclusion Criteria:\n\n* Uncontrolled medical comorbidities\n* Not able to perform outcome measurements\n* Aphasia, which hamper communication\n* Pre-diagnosed psychological or other neurological disease not relevant to stroke or brain injury'}, 'identificationModule': {'nctId': 'NCT02384057', 'briefTitle': 'Cognitive Rehabilitation With C8 Sciences', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Rehabilitation Center, Seoul, Korea'}, 'officialTitle': 'Cognitive Rehabilitation for Participants With Stroke or Brain Injury Using C8 Sciences', 'orgStudyIdInfo': {'id': 'NRC-2013-04-036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C8 sciences', 'description': 'cognitive rehabilitation with C8 sciences', 'interventionNames': ['Other: Computerized cognitive training program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional cognitive rehabilitation', 'description': 'cognitive rehabilitation with conventional methods', 'interventionNames': ['Other: Conventional cognitive rehabilitation']}], 'interventions': [{'name': 'Computerized cognitive training program', 'type': 'OTHER', 'description': '1000 minutes of computerized cognitive rehabilitation with C8 sciences program', 'armGroupLabels': ['C8 sciences']}, {'name': 'Conventional cognitive rehabilitation', 'type': 'OTHER', 'description': 'Same amount of conventional cognitive rehabilitation', 'armGroupLabels': ['Conventional cognitive rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '142884', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'National Rehabilitation Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Rehabilitation Center, Seoul, Korea', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Hanyang University', 'class': 'OTHER'}, {'name': 'National IT Industry Promotion Agency, Republic of Korea', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Team manager', 'investigatorFullName': 'Joon-Ho Shin', 'investigatorAffiliation': 'National Rehabilitation Center, Seoul, Korea'}}}}