Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-09 @ 12:12 PM
Study NCT ID:
NCT02362633
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2015-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Long-term Transcranial Direct Current Stimulation (tDCS) on Appetite Control Related Brain Regions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'lastUpdateSubmitDate': '2016-02-03', 'studyFirstSubmitDate': '2015-02-02', 'studyFirstSubmitQcDate': '2015-02-09', 'lastUpdatePostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regional brain activity measured by blood-oxygen-level dependent (BOLD) signal of functional MRI', 'timeFrame': 'Day 14 (After ten interventions)', 'description': '3T MR scanner with Echo Planar Imaging(EPI) capability(Magnetom, Siemens Medical System)'}], 'secondaryOutcomes': [{'measure': 'Behavior outcomes on the visual analog scale', 'timeFrame': 'Day 14 (After ten interventions)', 'description': 'Hunger related visual analogue scale (VAS) - 8 items (Flint et al., 2000) Mood related visual analogue scale (VAS) - 16 items (Fregni et al., 2008)'}]}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the long-term effect of Transcranial Direct Current Stimulation (tDCS) on appetite control related brain regions.', 'detailedDescription': 'Transcranial direct current stimulation (tDCS) is emerging tool for brain modulation in a variety of clinical conditions. In addition, recent neuroimaging studies suggest that modifying the activity of brain circuits involved in eating behavior could provide therapeutic benefits in obesity.\n\nThe investigators aim to assess whether long-term modulation of the dorsolateral prefrontal cortex (DLFPC) using tDCS, modifies behavioral response and brain activity while watching visually presented food cues and taste cues in obese subjects.\n\nSubjects will be randomly divided into sham and real tDCS arms. Subjects will receive sham or real tDCS ten times. Subjects will be investigated before and after sham or real tDCS interventions. Subjects will perform functional MRI experiments with visual and taste food cues. Questionnaire with behavior measures, body compositions, blood tests will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 26 kg/m2\n\nExclusion Criteria:\n\n* History of brain trauma, epilepsy, or other neurological problems'}, 'identificationModule': {'nctId': 'NCT02362633', 'briefTitle': 'Effect of Long-term Transcranial Direct Current Stimulation (tDCS) on Appetite Control Related Brain Regions', 'organization': {'class': 'OTHER', 'fullName': 'Chungbuk National University'}, 'officialTitle': 'Effect of Long-term Transcranial Direct Current Stimulation (tDCS) on Appetite Control Related Brain Regions', 'orgStudyIdInfo': {'id': '2014-07-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Real tDCS', 'description': 'Subjects will receive real tDCS treatment for ten times for two weeks (five times per week).', 'interventionNames': ['Device: real tDCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': 'Subjects will receive sham tDCS treatment for ten times for two weeks (five times per week).', 'interventionNames': ['Device: sham tDCS']}], 'interventions': [{'name': 'real tDCS', 'type': 'DEVICE', 'description': 'For active tDCS, a 2 mA current will be delivered for 20 minutes with 20 second up and down ramp times. The anodal electrode will be placed on the right DLPFC (F4; 10-20 EEG system), and the cathode electrode will be placed on the left DLPFC (F4;10-20 EEG system), which is known to be related to cognitive function. The electrodes used for tDCS are saline-soaked sponges (25 cm2).', 'armGroupLabels': ['Real tDCS']}, {'name': 'sham tDCS', 'type': 'DEVICE', 'description': 'Sham tDCS will be delivered for 20 minutes. The anodal electrode will be placed on the right DLPFC (F4; 10-20 EEG system), and the cathode electrode will be placed on the left DLPFC (F4;10-20 EEG system), which is known to be related to cognitive function. The electrodes used for tDCS are saline-soaked sponges (25 cm2).', 'armGroupLabels': ['Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361-711', 'city': 'Cheongju-si', 'state': 'North Chungcheong', 'country': 'South Korea', 'facility': 'Chungbuk National University', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chungbuk National University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Hyung Jin Choi', 'investigatorAffiliation': 'Chungbuk National University'}}}}