Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-02-25 @ 6:51 PM
Study NCT ID:
NCT03325205
Status:
COMPLETED
Last Update Posted:
2021-01-14
First Post:
2017-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MR Guided tDCS in Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2017-09-04', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance on Neuropsychological tests', 'timeFrame': '4 months', 'description': 'Compare scores before and after tDCS stimulation'}], 'secondaryOutcomes': [{'measure': 'Hippocampal volume', 'timeFrame': '4 months', 'description': 'Compare performance on neuropsychological tests to hippocampal volume. Here we are looking at correlations between hippocampal thickness, performance on neuropsychological tests and effect of tDCS.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcranial direct current stimulation', 'Neuromodulation', 'Individualizing brain stimulation', 'Neuropsychology'], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '34366347', 'type': 'DERIVED', 'citation': "Rasmussen ID, Boayue NM, Mittner M, Bystad M, Gronli OK, Vangberg TR, Csifcsak G, Aslaksen PM. High-Definition Transcranial Direct Current Stimulation Improves Delayed Memory in Alzheimer's Disease Patients: A Pilot Study Using Computational Modeling to Optimize Electrode Position. J Alzheimers Dis. 2021;83(2):753-769. doi: 10.3233/JAD-210378."}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to investigate the effect of High Density- tDCS (HD- tDCS) on cognitive function in Alzheimer's Disease. One anode and four return electrodes are placed over DLPFC, where low intensity current (2mA) is induced to the surface of the scalp. Electrode placement is individualized for each participant. Participants will undergo 15 stimulations, with a duration of 20 minutes each. All patients will undergo neuropsychological assessment and MRI evaluation.", 'detailedDescription': 'The project will be run as a Randomized Controlled Trial (RCT), where patients will be randomized to receive either active anodal tDCS or sham tDCS. The performance on neuropsychological tests will be the primary outcome variables in the present project. In addition, whole brain MRI volume measures will be used to measure specific effects of tDCS treatment. Electrode placement is individualized for each participant with brain modeling techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Alzheimer's Disease, mild and moderate stage\n\nExclusion Criteria:\n\n* Other neurological diseases or injuries\n* Stroke\n* Cancer\n* Psychiatric disorders (moderate/ severe depression, psychosis)"}, 'identificationModule': {'nctId': 'NCT03325205', 'briefTitle': "MR Guided tDCS in Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Tromso'}, 'officialTitle': "MR Guided tDCS: The Effect of Repeated Transcranial Direct Current Stimulation on Cognitive Functioning in Alzheimer's Disease", 'orgStudyIdInfo': {'id': '2017/794 (REK)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active tDCS', 'description': 'Participants receive anodal tDCS over DLPFC. Each sessions lasts for 20 minutes, with a total of 15 stimulations: 6 acute sessions, 9 maintenance sessions.', 'interventionNames': ['Other: Anodal tDCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': 'Participants receive sham tDCS over DLPFC. Each sessions lasts for 20 minutes, with a total of 15 stimulations: 6 acute sessions, 9 maintenance sessions.', 'interventionNames': ['Other: Sham tDCS']}], 'interventions': [{'name': 'Anodal tDCS', 'type': 'OTHER', 'description': 'Anodal Transcranial direct current stimulation (tDCS) is a non- invasive brain stimulation technique. Low intensity current (1-2 mA) is induced to increase excitability, stimulate plasticity and enhance cognitive functions.', 'armGroupLabels': ['Active tDCS']}, {'name': 'Sham tDCS', 'type': 'OTHER', 'description': 'The electrodes are placed over the same areas as in the anodal tDCS condition. Participants will receive sham tDCS instead of anodal tDCS', 'armGroupLabels': ['Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tromsø', 'country': 'Norway', 'facility': 'Department of Psychology, University of Northern Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'overallOfficials': [{'name': 'Per M Aslaksen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tromso'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tromso', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helse Nord', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}