Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-31 @ 3:21 AM
Study NCT ID:
NCT02790151
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2015-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Memory Rehabilitation by Means of Working Memory Training in Combination With a Recollection Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008569', 'term': 'Memory Disorders'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-17', 'studyFirstSubmitDate': '2015-03-02', 'studyFirstSubmitQcDate': '2016-06-02', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test to assess change in memory performance in everyday life', 'timeFrame': 'baseline and 9 hours', 'description': 'The test includes different single tasks that measure memory in everyday life e.g. Story recall (Subtest 6 from the Rivermead Behavioral Memory Test) Outcome measure: Total number of points'}], 'secondaryOutcomes': [{'measure': 'Outcome change in different neuropsychological tests', 'timeFrame': 'baseline and 9 hours', 'description': 'Tests for verbal memory, working memory, prospective memory, attention and word fluency (Composite scores built from raw scores)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['working memory, recollection training, transfer'], 'conditions': ['Memory Deficits']}, 'referencesModule': {'references': [{'pmid': '29697993', 'type': 'DERIVED', 'citation': 'Richter KM, Modden C, Eling P, Hildebrandt H. Improving everyday memory performance after acquired brain injury: An RCT on recollection and working memory training. Neuropsychology. 2018 Jul;32(5):586-596. doi: 10.1037/neu0000445. Epub 2018 Apr 26.'}]}, 'descriptionModule': {'briefSummary': 'Memory deficits after brain damage are common and there is still a need for evaluated therapy methods. In this study we compare two therapeutic interventions and investigate whether therapy effects can be found on neuropsychological tests and on a test measuring memory in everyday life.', 'detailedDescription': 'In the interventiongroup a computerbased working memory training is combined with a recollection training (repitition-lag procedure). The patients in the active control group undergo the standard memory therapy that is normally provided in the rehabilitation centre (with a focus on the acquisition and execution of different memory strategies, e.g. the spaced retrieval method). The patients in both groups are tested on different neuropsychological tests before and after nine hours of therapy. Additionally, a test is conducted that assesses memory in everyday life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* brain injury\n* memory deficits (performance below average in the California Verbal Learning Test in learning trial 1 or 5, sfr or lfr)\n\nExclusion Criteria:\n\n* severe amnesia (less than 2 words in sfr of the CVLT), dementia, sensory or motor aphasia, impaired vision, insufficient German language skills, lack of patient's consent"}, 'identificationModule': {'nctId': 'NCT02790151', 'briefTitle': 'Memory Rehabilitation by Means of Working Memory Training in Combination With a Recollection Training', 'organization': {'class': 'OTHER', 'fullName': 'University of Oldenburg'}, 'officialTitle': 'Memory Rehabilitation by Means of Working Memory Training in Combination', 'orgStudyIdInfo': {'id': 'UOLDENBURG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Therapy', 'description': 'Learning and practicing memory strategies', 'interventionNames': ['Behavioral: Standard Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Intervention', 'description': 'Computerbased working memory training and Recollection training', 'interventionNames': ['Behavioral: Experimental Intervention']}], 'interventions': [{'name': 'Standard Therapy', 'type': 'BEHAVIORAL', 'description': 'Learning and practicing Memory strategies', 'armGroupLabels': ['Standard Therapy']}, {'name': 'Experimental Intervention', 'type': 'BEHAVIORAL', 'description': 'Computerbased Working Memory Training in Combination with a Recollection Training', 'armGroupLabels': ['Experimental Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26131', 'city': 'Oldenburg', 'state': 'Deutschland', 'country': 'Germany', 'facility': 'Rehabilitationszentrum GmbH', 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}], 'overallOfficials': [{'name': 'Helmut Hildebrandt, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universität Oldenburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oldenburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc Psychologie', 'investigatorFullName': 'Kim Merle Richter', 'investigatorAffiliation': 'University of Oldenburg'}}}}