Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-26 @ 4:07 PM
Study NCT ID:
NCT04759092
Status:
COMPLETED
Last Update Posted:
2021-10-11
First Post:
2021-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Four Month Home Based tDCS Study on Patients With 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Treatment study, open label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-04', 'studyFirstSubmitDate': '2021-01-28', 'studyFirstSubmitQcDate': '2021-02-12', 'lastUpdatePostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate adverse effects of the treatment', 'timeFrame': '4 months', 'description': "Investigation of tolerability of long term home based tDCS to patients with Alzheimer's by using the Adverse effect questionnaire for tDCS"}, {'measure': 'To investigate effect of the treatment', 'timeFrame': '8 months', 'description': 'Investigate possible change in cognitive tests (Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Mini Mental Status Examination ( MMSE), Clock drawing test, Trail making test A \\& B) after 4 months treatment and change 4 months after end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '35852094', 'type': 'DERIVED', 'citation': "Gronli OK, Daae Rasmussen I, Aslaksen PM, Bystad M. A four-month home-based tDCS study on patients with Alzheimer's disease. Neurocase. 2022 Jun;28(3):276-282. doi: 10.1080/13554794.2022.2100710. Epub 2022 Jul 19."}]}, 'descriptionModule': {'briefSummary': "The study is an open label study on patients with Alzheimer's dementia using home based transcranial direct current (tDCS) stimulation. Aims of the study is to investigate applicability and effect of treatment.", 'detailedDescription': 'Active tDCS of 2mA is applied via surface based electrodes daily for 30 minutes over a 4 month period. Anodal electrode is placed over the left temporal lobe. Participants is followed up by home visit and phone calls.\n\nCognitive tests are performed prior to the treatment period, right after finishing 4 months of treatment and 4 months after treatment is terminated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 60-85.\n* Fulfil diagnostic criteria of probable Alzheimer's dementia.\n* Participants has to live with a caregiver.\n* If medicated with cholinesterase inhibitors or memantine, a stable dose the last three months before inclusion is required.\n\nExclusion Criteria:\n\n* Implant in head\n* Seizure history\n* Severe illness,\n* Psychosis or depression measured with a cornell score over 11.\n* Mini mental status (MMSE) score\\<17."}, 'identificationModule': {'nctId': 'NCT04759092', 'acronym': 'tDCS', 'briefTitle': "A Four Month Home Based tDCS Study on Patients With Alzheimer's Disease.", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of North Norway'}, 'officialTitle': "A Four Month Home Based tDCS Study on Patients With Alzheimer's Disease.", 'orgStudyIdInfo': {'id': 'TDCS1HB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with tDCS', 'description': 'Home based treatment with tDCS for four months', 'interventionNames': ['Device: transcranial direct current stimulation (tDCS)']}], 'interventions': [{'name': 'transcranial direct current stimulation (tDCS)', 'type': 'DEVICE', 'otherNames': ['tDCS'], 'description': 'Apply 30min low dose (2mA) transcranial current stimulation on the scalp every day for four months.', 'armGroupLabels': ['Treatment with tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9091', 'city': 'Tromsø', 'state': 'Troms', 'country': 'Norway', 'facility': 'University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'overallOfficials': [{'name': 'Ole K Grønli Grønli, MD/PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of North Norway'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan of sharing individual participant data, because its not a part of the approvement of the advisory board.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Tromso', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD/phd senior consultant', 'investigatorFullName': 'Ole Kristian Grønli', 'investigatorAffiliation': 'University Hospital of North Norway'}}}}