Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-01 @ 6:20 PM
Study NCT ID:
NCT02839993
Status:
COMPLETED
Last Update Posted:
2021-05-07
First Post:
2016-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
tDCS Effects on Associative Learning in Older Adults of Retirement Age
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-05', 'studyFirstSubmitDate': '2016-04-05', 'studyFirstSubmitQcDate': '2016-07-18', 'lastUpdatePostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance in a verbal associative learning paradigm under anodal tDCS compared to sham tDCS.', 'timeFrame': 'Performance is assessed within 1 day immediately after training period (several learning blocks) compared to sham', 'description': 'Investigation whether anodal tDCS leads to improved performance accuracy in the Wernicko task compared to sham stimulation.'}], 'secondaryOutcomes': [{'measure': 'Functional connectivity predictors', 'timeFrame': 'assessed during baseline testing', 'description': 'Connectivity as measured by resting-state fMRI during baseline as predictors for performance and tDCS responsiveness'}, {'measure': 'Structural predictors', 'timeFrame': 'assessed during baseline testing', 'description': 'Microstructure of white matter (Fractional Anisotropy) as measured by diffusion tensor imaging during baseline as predictors for performance and tDCS responsiveness'}, {'measure': 'Genotyping of learning related polymorphisms', 'timeFrame': 'assessed during baseline screening', 'description': 'To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed.'}, {'measure': 'Other cognitive outcomes: Attention performance', 'timeFrame': 'Performance is assessed within 1 day before and after tDCS + training compared to sham', 'description': 'Digit span forward performance assessed before and after stimulation to test for tDCS effects on attention'}, {'measure': 'Other cognitive outcomes: working memory', 'timeFrame': 'Performance is assessed within 1 day before and after tDCS + training compared to sham', 'description': 'Digit span backwards performance assessed before and after stimulation to test for tDCS effects on working memory'}]}, 'conditionsModule': {'keywords': ['tDCS effects', 'associative learning'], 'conditions': ['Healthy Older Adults']}, 'referencesModule': {'references': [{'pmid': '18303984', 'type': 'BACKGROUND', 'citation': 'Floel A, Rosser N, Michka O, Knecht S, Breitenstein C. Noninvasive brain stimulation improves language learning. J Cogn Neurosci. 2008 Aug;20(8):1415-22. doi: 10.1162/jocn.2008.20098.'}, {'pmid': '11856568', 'type': 'BACKGROUND', 'citation': 'Breitenstein C, Knecht S. Development and validation of a language learning model for behavioral and functional-imaging studies. J Neurosci Methods. 2002 Mar 15;114(2):173-9. doi: 10.1016/s0165-0270(01)00525-8.'}, {'pmid': '15808996', 'type': 'BACKGROUND', 'citation': 'Breitenstein C, Jansen A, Deppe M, Foerster AF, Sommer J, Wolbers T, Knecht S. Hippocampus activity differentiates good from poor learners of a novel lexicon. Neuroimage. 2005 Apr 15;25(3):958-68. doi: 10.1016/j.neuroimage.2004.12.019.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual associative memory leads to a performance improvement in healthy older individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '66 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: old-retired (≥66 years).\n* Right handedness\n* unobtrusive neuropsychological screening\n\nExclusion Criteria:\n\n* Mild cognitive impairment (MCI) or other neurological diseases.\n* History of severe alcoholism or use of drugs.\n* Severe psychiatric disorders such as depression, psychosis (if not in remission) and severe untreated medical problems.\n* Contraindication for MRI (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women)'}, 'identificationModule': {'nctId': 'NCT02839993', 'acronym': 'TRAINSTIM2', 'briefTitle': 'tDCS Effects on Associative Learning in Older Adults of Retirement Age', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Effects of Transcranial Direct Current Stimulation (tDCS) on Associative Learning in Older Adults', 'orgStudyIdInfo': {'id': 'TRAINSTIM2.A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anodal tDCS + training', 'description': 'Combination of intensive training of picture-word associations (Wernicko task) with anodal stimulation', 'interventionNames': ['Device: tDCS', 'Behavioral: training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS + training', 'description': 'Combination of intensive training of picture-word associations (Wernicko task) with sham stimulation', 'interventionNames': ['Device: tDCS', 'Behavioral: training']}], 'interventions': [{'name': 'tDCS', 'type': 'DEVICE', 'armGroupLabels': ['Anodal tDCS + training', 'Sham tDCS + training']}, {'name': 'training', 'type': 'BEHAVIORAL', 'otherNames': ['intensive training of picture-word associations'], 'armGroupLabels': ['Anodal tDCS + training', 'Sham tDCS + training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité 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'}}}}