Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT02110056
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2014-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modulation of Visual-Spatial Learning in Healthy Older Adults by tDCS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2014-02-13', 'studyFirstSubmitQcDate': '2014-04-08', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance in LOCATO task (Visual-Spatial learning and memory) after a combination of intensive visual-spatial training and tDCS', 'timeFrame': 'immediately after the end of a 3 day training period in tDCS condition compared to sham condition', 'description': 'Investigation whether the combination of intensive visual-spatial training (LOCATO task) and tDCS leads to an improvement of visual-spatial learning and memory measured by performance in LOCATO task after end of a 3 day training period compared to sham stimulation.'}], 'secondaryOutcomes': [{'measure': 'long term effects', 'timeFrame': 'after 1 month vs baseline', 'description': 'long term effects measured by performance in LOCATO task after end of training and after 1 month compared to control condition'}, {'measure': 'functional changes: Connectivity', 'timeFrame': 'after end of 3-day period of training vs baseline', 'description': 'Connectivity (measured by resting-state fMRT and correlation analysis) at baseline compared to end of 3 day period of training'}, {'measure': 'cortical excitability', 'timeFrame': 'at baseline', 'description': 'measured by transcranial magnetic stimulation (TMS) at baseline'}, {'measure': 'Quality of life', 'timeFrame': 'after 1 month vs baseline', 'description': 'quality of life as measured by standardized questionaire at baseline compared to quality of life measured 1 month after intervention (training and stimulation vs. training and sham-stimualtion)'}, {'measure': 'memory', 'timeFrame': 'immediately after end of 3-day of cognitive training, after 1 month vs. baseline', 'description': 'memory performance tested at baseline compared to memory performance after the end of a 3-day cognitive training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation'}, {'measure': 'affective state', 'timeFrame': 'immediately after the end of 3-day cognitive training, after 1 month vs. baseline', 'description': 'affective state measured at baseline compared to affective state measured after the end of a 3-day cognitve training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation'}, {'measure': 'genotyping of learning related polymorphisms', 'timeFrame': 'once', 'description': 'To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed (i.e., APOE, BDNF Val66Met, COMT Val158Met).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['healthy older adults', 'tDCS', 'LOCATO task', 'visual-spatial learning'], 'conditions': ['Healthy Older Adults']}, 'referencesModule': {'references': [{'pmid': '27047376', 'type': 'RESULT', 'citation': 'Antonenko D, Kulzow N, Cesarz ME, Schindler K, Grittner U, Floel A. Hippocampal Pathway Plasticity Is Associated with the Ability to Form Novel Memories in Older Adults. Front Aging Neurosci. 2016 Mar 22;8:61. doi: 10.3389/fnagi.2016.00061. eCollection 2016.'}, {'pmid': '29050849', 'type': 'RESULT', 'citation': 'Antonenko D, Kulzow N, Sousa A, Prehn K, Grittner U, Floel A. Neuronal and behavioral effects of multi-day brain stimulation and memory training. Neurobiol Aging. 2018 Jan;61:245-254. doi: 10.1016/j.neurobiolaging.2017.09.017. Epub 2017 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement of learning and memory in healthy older adults and to examine the underlying neuronal mechanism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (old healthy controls):\n\n* right handedness\n* unobtrusive neuropsychological screening\n* age: 50-90 years\n\nExclusion Criteria:\n\n* severe internal or psychiatric disease\n* epilepsy\n* other severe neurological diseases, e.g. previous major stroke or brain tumor\n* DMS-IV manifest dementia\n* contraindication for MRT (claustrophobia, metallic implants, tattoos)'}, 'identificationModule': {'nctId': 'NCT02110056', 'briefTitle': 'Modulation of Visual-Spatial Learning in Healthy Older Adults by tDCS', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Modulation of Visual-Spatial Learning in Healthy Older Adults by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms', 'orgStudyIdInfo': {'id': 'LOCATO-OA-tDCS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'training + tDCS', 'description': 'Combination of intensive training of visual-spatial abilities (LOCATO task) with transcranial direct current stimulation (tDCS)', 'interventionNames': ['Device: tDCS', 'Behavioral: training']}, {'type': 'SHAM_COMPARATOR', 'label': 'training + sham stimulation', 'description': 'Combination of intensive training of visual-spatial abilities (LOCATO task) with sham stimulation', 'interventionNames': ['Device: tDCS', 'Behavioral: training']}], 'interventions': [{'name': 'tDCS', 'type': 'DEVICE', 'description': 'transcranial direct current stimulation (tDCS)', 'armGroupLabels': ['training + sham stimulation', 'training + tDCS']}, {'name': 'training', 'type': 'BEHAVIORAL', 'description': 'intensive training of visual-spatial abilities (in LOCATO task)', 'armGroupLabels': ['training + sham stimulation', 'training + tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Agnes Flöel, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Agnes Flöel', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}