Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-29 @ 9:04 PM
Study NCT ID:
NCT04134195
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2019-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Transcranial Direct Current Stimulation on Visual Attention - Single Sessions
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'}]}, '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': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2019-10-18', 'studyFirstSubmitQcDate': '2019-10-18', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual-attention task accuracy', 'timeFrame': 'Change from baseline immediately after completion of stimulation protocol', 'description': 'Task will be presented on a computer and subject will respond by YES-NO buttons. Only if there are no differences in task accuracy, we will measure task reaction times (e.g. due to the roof effect).'}, {'measure': 'Magnetic resonance imaging', 'timeFrame': 'Change from baseline immediately after completion of stimulation protocol', 'description': 'Investigator will record high resolution structural T1-weighted (MPRAGE) images, functional T2\\* weighted multiband EPI sequences. The total time spent in the scanner will be approximately 40 in every session.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcranial direct current stimulation', 'Healthy seniors', 'Healthy adults'], 'conditions': ['Healthy Aging', 'Cognitive Change', 'Cognitive Decline']}, 'descriptionModule': {'briefSummary': 'Recently, attention has been drawn to non-invasive brain stimulation techniques, such as transcranial direct current stimulation (tDCS), in order to enhance cognitive functions by modifying brain plasticity and use it in different healthy and diseased populations. In the current research, investigator aim to examine the short-term effects of multiple tDCS protocols in healthy adults population on visual attention and identify the neural underpinnings of tDCS-induced behavioral aftereffects using a combined tDCS/ MRI network-based approach.', 'detailedDescription': 'Investigator will investigate the shor-term effects of active tDCS as compared to a placebo stimulation on visual attention in the healthy seniors. A cross-over, randomized, placebo-controlled design will be used. Single tDCS sessions will be performed in 4 sessions over distinct brain areas with ongoing visual attention training. During the stimulation, investigator will use the visual matching task. MRI protocol consisting of T1 and resting state fMRI sequences will be acquired before and after every stimulation session in order to search for active vs. placebo tDCS-induced changes in brain activation and resting state functional connectivity and to identify neural correlates of behavioral changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* right handed, healthy volunteers in two groups - healthy adults under 40 years, healthy seniors over 50 years\n\nExclusion Criteria:\n\n* psychiatric disorders, including major depression, major vascular lesions, and other brain pathologies detected by MRI that might present with cognitive decline\n\n * a cardio pacemaker or any MRI-incompatible metal in the body\n * epilepsy\n * any diagnosed psychiatric disorder\n * alcohol/drug abuse\n * lack of cooperation\n * presence of cognitive impairment'}, 'identificationModule': {'nctId': 'NCT04134195', 'briefTitle': 'The Effect of Transcranial Direct Current Stimulation on Visual Attention - Single Sessions', 'organization': {'class': 'OTHER', 'fullName': 'Masaryk University'}, 'officialTitle': 'The Effect of Transcranial Direct Current Stimulation on Visual Attention - a Combined MRI and Non-invasive Brain Stimulation Single Session Study', 'orgStudyIdInfo': {'id': 'NV18-04-00256-single'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Real transcranial direct current stimulation', 'description': 'Healthy adults and healthy seniors will undergo application of real transcranial direct current stimulation over two distinct brain areas.', 'interventionNames': ['Device: Transcranial direct current stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Sham transcranial direct current stimulation', 'description': 'Healthy adults and healthy seniors will undergo application of sham transcranial direct current stimulation over two distinct brain areas.', 'interventionNames': ['Device: Transcranial direct current stimulation']}], 'interventions': [{'name': 'Transcranial direct current stimulation', 'type': 'DEVICE', 'description': '2mA stimulation for 20 minutes', 'armGroupLabels': ['Real transcranial direct current stimulation', 'Sham transcranial direct current stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61300', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Ceitec, Masaryk University', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'overallOfficials': [{'name': 'Ľubomira Nováková', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ceitec, Masaryk University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masaryk University', 'class': 'OTHER'}, 'collaborators': [{'name': "St. Anne's University Hospital Brno, Czech Republic", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}