Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
Study NCT ID:
NCT00695708
Status:
COMPLETED
Last Update Posted:
2010-04-13
First Post:
2008-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Training-induced Cerebral Reorganization in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-12', 'studyFirstSubmitDate': '2008-06-09', 'studyFirstSubmitQcDate': '2008-06-09', 'lastUpdatePostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event related potential MEG, test scores in word fluency and verbal learning tasks', 'timeFrame': 'pre and post intervention'}], 'secondaryOutcomes': [{'measure': 'Symptom severity, GAF score', 'timeFrame': 'pre and post intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['schizophrenia', 'neuroplasticity', 'sensory gating', 'cognitive impairment', 'MEG', 'Disorders with Psychotic Features'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '21092939', 'type': 'DERIVED', 'citation': 'Popov T, Jordanov T, Rockstroh B, Elbert T, Merzenich MM, Miller GA. Specific cognitive training normalizes auditory sensory gating in schizophrenia: a randomized trial. Biol Psychiatry. 2011 Mar 1;69(5):465-71. doi: 10.1016/j.biopsych.2010.09.028. Epub 2010 Nov 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to reveal the effects of computer-aided cognitive-auditory training on cerebral reorganization in schizophrenia.', 'detailedDescription': 'Impairment in cognitive functions is one of the main symptoms in schizophrenia and is currently one of the challenges in the treatment of the disease.\n\nIn this study we compare effects of two computer-aided training programs. One focused on auditory perception and processing as a basic ability underlying higher order information processing.\n\nThe other training involves a variability of cognitive abilities.\n\nBoth trainings are computer-aided and time-intensive, including up to twenty sessions within four weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of schizophrenia and disorders with psychotic features\n* Intact hearing abilities\n\nExclusion Criteria:\n\n* Mental retardation\n* Age over 60\n* Insufficient German language knowledge'}, 'identificationModule': {'nctId': 'NCT00695708', 'briefTitle': 'Training-induced Cerebral Reorganization in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University of Konstanz'}, 'officialTitle': 'Training-induced Cerebral Reorganization in Schizophrenia', 'orgStudyIdInfo': {'id': 'RO 805/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BFT', 'description': '20 schizophrenic patients', 'interventionNames': ['Behavioral: Brain Fitness Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CP', 'description': '19 schizophrenic patients', 'interventionNames': ['Behavioral: Cogpack']}, {'type': 'NO_INTERVENTION', 'label': 'HCG', 'description': '20 healthy age and sex matched subjects'}], 'interventions': [{'name': 'Brain Fitness Program', 'type': 'BEHAVIORAL', 'description': 'Computer-aided cognitive program designed for intensive training of auditory perception, memory and attention', 'armGroupLabels': ['BFT']}, {'name': 'Cogpack', 'type': 'BEHAVIORAL', 'description': 'Computer-aided cognitive program for cognitive abilities', 'armGroupLabels': ['CP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78457', 'city': 'Konstanz', 'state': 'Baden Württenberg', 'country': 'Germany', 'facility': 'University of Konstanz', 'geoPoint': {'lat': 47.66033, 'lon': 9.17582}}], 'overallOfficials': [{'name': 'Brigitte Rockstroh, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Konstanz, Department of Psychology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Konstanz', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Rockstroh Brigitte, Prof. Dr.', 'oldOrganization': 'University of Konstanz'}}}}