Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-28 @ 2:51 AM
Study NCT ID:
NCT02940457
Status:
WITHDRAWN
Last Update Posted:
2020-05-26
First Post:
2016-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Ability Training for Seniors With Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The employe for the study quit and a new grant proposal was not financed', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-20', 'studyFirstSubmitDate': '2016-10-11', 'studyFirstSubmitQcDate': '2016-10-18', 'lastUpdatePostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain activation measured with NIRS', 'timeFrame': '4 weeks', 'description': 'The Investigators are measuring brain activation during executive functions'}, {'measure': 'Reaction times, errors and number of generated words in neuropsychological tasks', 'timeFrame': '4 weeks', 'description': 'The Investigators are measuring cognitive performance for different executive functions'}], 'secondaryOutcomes': [{'measure': 'T1 weighted magnetic resonance Imaging (MRI) of the brain', 'timeFrame': '4 weeks', 'description': 'Structural changes in grey matter of the brain calculated by voxel based morphometry (VBM)'}, {'measure': 'Blood sampling', 'timeFrame': '4 weeks', 'description': 'Increased BDNF secretion in serum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tDCS', 'MCI', 'Working Memory', 'fNIRS'], 'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'This study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation \\[tDCS\\]) during working memory training in seniors with mild cognitive impairments.The placebo-controlled double blinded study includes 50 elderly patients which will be randomized into verum or sham tDCS.', 'detailedDescription': 'In this project, we want to test whether the effectiveness of neuropsychological exercise therapy can be increased in elderly persons suspected of having an MCI by means of parallel tDCS treatment.\n\nAll test participants train over 6 sessions within 2 weeks two different working memory tasks with increasing difficulty. In the randomized, double-blind, prospective therapy study, participants are assigned to either a Verum-tDCS or a placebo-tDCS group. The Verum-tDCS group receives active stimulation in parallel to the exercise therapy, while the placebo group does not receive tDCS stimulation. To check the effects of the therapy, we measure performance and neuronal activation in different executive tasks using near-infrared spectroscopy (NIRS). Furthermore, we will check whether the training increases the volume of the grey matter (Draganski et al., 2004, Malchow et al., 2016) and the expression of BDNF can be increased (Schuch et al., 2015).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suspected MCI\n* total CERAD score \\<= 85.1\n* MMSE \\>=24\n* native german speaker\n* between 50-75 years old\n* right handed\n\nExclusion Criteria:\n\n* impairment of daily living activities\n* psychiatric, neurological diseases\n* uncorrected hearing or vision deficits\n* actual psychopharmaca intake\n* metal parts in the head\n* medical electronical implants'}, 'identificationModule': {'nctId': 'NCT02940457', 'acronym': 'MICE', 'briefTitle': 'Cognitive Ability Training for Seniors With Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Wuerzburg University Hospital'}, 'officialTitle': 'Verbesserung Kognitiver Fähigkeiten Bei Personen Mit Verdacht Auf Eine Leichte Kognitive Beeinträchtigung', 'orgStudyIdInfo': {'id': 'Wuerzburg165/16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Verum tDCS', 'description': 'prefrontal anodal stimulation', 'interventionNames': ['Device: Verum tDCS']}, {'type': 'EXPERIMENTAL', 'label': 'Sham tDCS', 'description': 'sham stimulation, same electrode positions', 'interventionNames': ['Device: Sham tDCS']}], 'interventions': [{'name': 'Verum tDCS', 'type': 'DEVICE', 'description': 'Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 2 mA', 'armGroupLabels': ['Verum tDCS']}, {'name': 'Sham tDCS', 'type': 'DEVICE', 'description': 'Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 0 mA', 'armGroupLabels': ['Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'University Hospital', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'Martin Herrmann', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wuerzburg University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}