Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT03522220
Status:
UNKNOWN
Last Update Posted:
2018-06-06
First Post:
2018-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Augmentation of Neuronal Network Plasticity in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-04', 'studyFirstSubmitDate': '2018-04-30', 'studyFirstSubmitQcDate': '2018-04-30', 'lastUpdatePostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'T1 - MRI', 'timeFrame': '2 months (= training time and 2 months after training end)', 'description': 'The investigators look for structural volume changes in T1 images (MRI) specifically in the hippocampus and prefrontal areas due to training'}, {'measure': 'Cognition - Spatial Orientation', 'timeFrame': '2 months (= training time and 2 months after training end)', 'description': 'The investigators look for changes in cognition specifically regarding spatial orientation (MATRICS, computer tests measuring spatial orientation with and without external cue) due to training.'}, {'measure': 'Positive & Negative Symptoms in patients', 'timeFrame': '2 months (= training time and 2 months after training end)', 'description': 'The investigators look for changes in positive and negative symptoms (PANSS) due to training.'}], 'secondaryOutcomes': [{'measure': 'Resting State fMRI', 'timeFrame': '2 months (= training time and 2 months after training end)', 'description': 'The investigators look for blood oxygen level dependency (BOLD) changes in resting state fMRI specifically in the Hippocampus and Prefrontal Areas due to the training'}, {'measure': 'Spectroscopy - glutamate', 'timeFrame': '2 month (= training time and 2 month after training end)', 'description': 'The investigators look for glutamate concentration changes in the hippocampus due to the training'}, {'measure': 'Diffusion Tensor Imaging (DTI)', 'timeFrame': '2 month (= training time and 2 month after training end)', 'description': 'The investigators look for structural connectivity changes in DTI images due to the training'}, {'measure': 'Biomarkers (BDNF & interleukin 1 & 6)', 'timeFrame': '2 month (= training time and 2 month after training end)', 'description': 'The investigators look for plasticity induced changes in biomarkers (interleukin1 and 6 and BDNF \\[brain-derived neurotrophic factor\\]) due to training'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sfb936.net/thematic-area-c', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Current pathophysiological models of schizophrenia focus on disconnectivity of distributed neuronal systems to explain the multitude of psychic symptoms. However, therapeutic strategies targeting this specific pathobiology are lacking. Our recent work provides strong evidence that complex video-game training interventions facilitate fronto-hippocampal structural and functional connectivity within 2 months in healthy subjects. The planned project transfers this knowledge into a training study in schizophrenic patients to counteract disease-related disconnectivity. Underlying mechanisms and behavioral effects are extensively parametrized by resting state functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI), spectroscopy and clinical short- and long-term outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinically stabilized\n* at least one schizophrenic episode in their lives\n* International Classification of Diseases 10 (ICD-10) F20.x (and F25)\n\nExclusion Criteria:\n\n* clinically relevant anemia\n* MRI contraindication\n* earlier electroconvulsive shock treatment\n* significant somatic or neurological disease\n* significant alcohol or substance abuse in the year before\n* more than 1h video games per day more than 6 months before study start\n* simultaneous major psychiatric disease (if symptomatic in the foreground)'}, 'identificationModule': {'nctId': 'NCT03522220', 'acronym': 'SCZ', 'briefTitle': 'Augmentation of Neuronal Network Plasticity in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Augmentation of Neuronal Network Plasticity in Schizophrenia', 'orgStudyIdInfo': {'id': 'SFB936 C7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D Super Mario Game Condition', 'description': '3D navigation video game intervention', 'interventionNames': ['Behavioral: 3D navigation video game intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2D Super Mario Game Condition', 'description': 'Video game intervention without 3D navigation', 'interventionNames': ['Behavioral: video game intervention without 3D navigation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Kindle Device', 'description': 'No 3D navigation', 'interventionNames': ['Behavioral: No 3D navigation']}], 'interventions': [{'name': '3D navigation video game intervention', 'type': 'BEHAVIORAL', 'description': 'Participants intensively train with a video game (Super Mario DS)', 'armGroupLabels': ['3D Super Mario Game Condition']}, {'name': 'video game intervention without 3D navigation', 'type': 'BEHAVIORAL', 'description': 'Participants train with a video game (Super Mario Bros)', 'armGroupLabels': ['2D Super Mario Game Condition']}, {'name': 'No 3D navigation', 'type': 'BEHAVIORAL', 'description': 'Participants read on a kindle device (control group)', 'armGroupLabels': ['Kindle Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20251', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Maxi Becker, MSc.', 'role': 'CONTACT', 'email': 'max.becker@uke.de'}, {'name': 'Simone Kuehn, Prof.', 'role': 'CONTACT', 'email': 's.kuehn@uke.de'}], 'facility': 'University Clinic Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Maxi Becker, MSc', 'role': 'CONTACT', 'email': 'max.becker@uke.de'}, {'name': 'Simone Kühn, Prof', 'role': 'CONTACT', 'email': 's.kuehn@uke.de'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}