Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-03 @ 4:26 AM
Study NCT ID:
NCT02794259
Status:
COMPLETED
Last Update Posted:
2017-01-06
First Post:
2016-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
tDCS Effects on GABA Concentration and Brain Functional Connectivity 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': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-05', 'studyFirstSubmitDate': '2016-04-05', 'studyFirstSubmitQcDate': '2016-06-03', 'lastUpdatePostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GABA concentration assessed by magnetic resonance spectroscopy (MRS) after anodal tDCS adjusted for baseline levels', 'timeFrame': 'assessed immediately before and after a 15-min stimulation time', 'description': 'Investigation whether anodal tDCS leads to a significant reduction of M1-GABA concentration in older adults compared to sham stimulation.'}], 'secondaryOutcomes': [{'measure': 'GABA concentration assessed by MRS before and after cathodal tDCS adjusted for baseline levels', 'timeFrame': 'assessed immediately before and after a 15-min stimulation time', 'description': 'To assess stimulation effects on GABA concentration by magnetic resonance spectroscopy are measured before and after cathodal tDCS.'}, {'measure': 'Resting-state functional connectivity changes', 'timeFrame': 'assessed during a 15-min stimulation time', 'description': 'Functional connectivity as measured by resting-state fMRI during tDCS compared to sham'}, {'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'}]}, 'conditionsModule': {'keywords': ['GABA concentration', 'tDCS'], 'conditions': ['Healthy Older Adults']}, 'referencesModule': {'references': [{'pmid': '24668166', 'type': 'BACKGROUND', 'citation': "Stagg CJ, Bachtiar V, Amadi U, Gudberg CA, Ilie AS, Sampaio-Baptista C, O'Shea J, Woolrich M, Smith SM, Filippini N, Near J, Johansen-Berg H. Local GABA concentration is related to network-level resting functional connectivity. Elife. 2014 Mar 25;3:e01465. doi: 10.7554/eLife.01465."}, {'pmid': '26381352', 'type': 'BACKGROUND', 'citation': 'Bachtiar V, Near J, Johansen-Berg H, Stagg CJ. Modulation of GABA and resting state functional connectivity by transcranial direct current stimulation. Elife. 2015 Sep 18;4:e08789. doi: 10.7554/eLife.08789.'}, {'pmid': '26279408', 'type': 'BACKGROUND', 'citation': 'Amadi U, Allman C, Johansen-Berg H, Stagg CJ. The Homeostatic Interaction Between Anodal Transcranial Direct Current Stimulation and Motor Learning in Humans is Related to GABAA Activity. Brain Stimul. 2015 Sep-Oct;8(5):898-905. doi: 10.1016/j.brs.2015.04.010. Epub 2015 May 1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a decrease of GABA concentration and alterations of functional brain connectivity in older people, compared to sham tDCS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '66 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unobtrusive neuropsychological screening\n* age: older adults of retirement age: ≥66 years\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': 'NCT02794259', 'acronym': 'TRAINSTIM1', 'briefTitle': 'tDCS Effects on GABA Concentration and Brain Functional Connectivity in Older Adults of Retirement Age', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Effects of Transcranial Direct Current Stimulation (tDCS) on GABA Concentration and Brain Functional Connectivity in Older Adults', 'orgStudyIdInfo': {'id': 'TRAINSTIM1.A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anodal tDCS', 'description': 'Anodal stimulation during resting state fMRI', 'interventionNames': ['Device: tDCS']}, {'type': 'EXPERIMENTAL', 'label': 'Cathodal tDCS', 'description': 'Cathodal stimulation during resting state fMRI', 'interventionNames': ['Device: tDCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': 'Sham stimulation during resting state fMRI', 'interventionNames': ['Device: sham-tDCS']}], 'interventions': [{'name': 'tDCS', 'type': 'DEVICE', 'armGroupLabels': ['Anodal tDCS', 'Cathodal tDCS']}, {'name': 'sham-tDCS', 'type': 'DEVICE', 'armGroupLabels': ['Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'state': 'State of 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'}, 'collaborators': [{'name': 'Physikalisch-Technische Bundesanstalt Institut Berlin (PTB)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.Dr.', 'investigatorFullName': 'Agnes Flöel', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}