Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT04420767
Status:
UNKNOWN
Last Update Posted:
2020-06-09
First Post:
2017-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Brain Stimulation (tDCS) in Food Cravings Control in Overweight/Obese Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-07-14', 'releaseDate': '2023-06-24'}], 'estimatedResultsFirstSubmitDate': '2023-06-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000073932', 'term': 'Food Addiction'}], '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'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001068', 'term': 'Feeding and Eating 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': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-03', 'studyFirstSubmitDate': '2017-04-21', 'studyFirstSubmitQcDate': '2020-06-03', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Diet (3-day food intake record)', 'timeFrame': 'Values measured at baseline and at up-to 2 weeks after the intervention', 'description': '3-day food intake record: individuals will record everything they eat and drink for 3 days. To assess calorie intake and macro nutrients'}, {'measure': 'Change in Yale Food Addiction Scale scores at 3-months post-intervention', 'timeFrame': 'At 3-months after intervention', 'description': 'Yale Food Addiction Scale (YFAS26) that is a 25-item measure developed to measure food addiction. Score range: 0 to 7. Higher scores in the scale mean more symptoms resembling food addiction (worse).'}, {'measure': 'Change in Three-Factor Eating Questionnaire scores at 3-months post-intervention', 'timeFrame': 'At 3-months after intervention', 'description': 'Three-Factor Eating Questionnaire is a validated scale that is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I), disinhibition (Factor II), and hunger (Factor III). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Higher scores in the respective scales are indicative of greater cognitive restraint (better), uncontrolled (worse), or emotional eating (worse).'}, {'measure': 'Cognitive function assessment', 'timeFrame': 'Measured at baseline and up-to 2 weeks after the intervention', 'description': 'Multiple Abilities Self-Report Questionnaire (MASQ), a self-report measure comprising items from five cognitive domains; language, visuo-perceptual, verbal memory, visual memory, and attention. The maximum score for the whole scale is 190 points. Higher scores correlate with better function.'}], 'primaryOutcomes': [{'measure': 'Change in Yale Food Addiction Scale scores', 'timeFrame': 'Scores measured at baseline and at up-to 2 weeks after the intervention', 'description': 'Yale Food Addiction Scale (YFAS26) that is a 25-item measure developed to measure food addiction. Score range: 0 to 7. Higher scores in the scale mean more symptoms resembling food addiction (worse).'}, {'measure': 'Change in Three-Factor Eating Questionnaire scores', 'timeFrame': 'Scores measured at baseline and at up-to 2 weeks after the intervention', 'description': 'Three-Factor Eating Questionnaire is a validated scale that is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I), disinhibition (Factor II), and hunger (Factor III). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Higher scores in the respective scales are indicative of greater cognitive restraint (better), uncontrolled (worse), or emotional eating (worse).'}], 'secondaryOutcomes': [{'measure': 'Change in brain neural activity by functional Magnetic Resonance Imaging ( fMRI)', 'timeFrame': 'Brain function at baseline and up-to 2 weeks after the intervention', 'description': 'Significant change in brain activity of the prefrontal cortex (area involved in the inhibitory control of food intake) measured by modification of BOLD (Blood-Oxygen-Level-Dependent) signal in fMRI evoked responses to visual food-cues'}, {'measure': 'Change in Brain metabolites concentrations by Magnetic Resonance Spectroscopy (MRS)', 'timeFrame': 'Brain MRS at baseline and up-to 2 weeks after the intervention', 'description': 'Significant change in brain metabolites concentration at the prefrontal cortex (area involved in the inhibitory control of food intake) measured with Magnetic Resonance spectroscopy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['food cravings', 'neuromodulation', 'brain', 'cognitive control', 'tDCS', 'prefrontal cortex', 'MRI', 'food addiction'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This study is a randomized clinical trial to test the effect of a type of non-invasive brain stimulation on the response to a behavioral intervention designed to enhance cognitive control over food cravings in obese and overweight women. The brain stimulation is called transcranial Direct Current Stimulation (tDCS). All eligible participants will engage in a behavioral intervention known to enhance control over food cravings and will be randomly assigned to receive either tDCS or sham stimulation to the prefrontal cortex of the brain.', 'detailedDescription': 'This study is a randomized clinical trial to test the effect of a type of non-invasive brain stimulation on the response to a behavioral intervention designed to enhance cognitive control over food cravings in obese and overweight women. The brain stimulation is called transcranial Direct Current Stimulation (tDCS) which is a form of stimulation that delivers a low amplitude electrical current to the brain via the scalp (i.e. trans-cranial) to modify brain activity.\n\nAll eligible participants will engage in a behavioral intervention (Go-No Go task), known to enhance control over food cravings, and will be randomly assigned to receive either tDCS or sham stimulation to the right prefrontal cortex of the brain during 8 20-min daily sessions.\n\nPrimary outcome: score changes in eating behaviors scales (YFAS and TFEQ), scales will be applied at baseline and at the end of the 8 brain stimulation sessions.\n\nSecondary outcomes: changes in diet, brain function (brain MRI/MRS) Other outcomes: food cravings scales and impulse control scales and cognitive function.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nBMI between 28 and 40 kg/m2 high scores in the Yale-Food Addiction-Scale right-handed\n\nExclusion Criteria:\n\n* History of anorexia nervosa or bulimia or binge eating disorder\n* Any contraindication to undergo MRI\n* Use of psychotropic medications and/or opiate pain medications.\n* Current or past alcohol or drug abuse problem or smoking\n* Pregnancy\n* Current use of weight loss medication or currently participating in a weight loss program.\n* History of seizures, epilepsy or factors/medications associated with lowered seizure threshold.\n* History of brain disease or major neurological disorder or mental disorder\n* History of brain surgery or history of loss of consciousness \\>15 min\n* History of major gastrointestinal surgery including weight loss surgery\n* History of endocrine imbalances including diabetes, thyroid disease, Cushing's disease, metabolic syndrome and polycystic ovary."}, 'identificationModule': {'nctId': 'NCT04420767', 'briefTitle': 'The Effect of Brain Stimulation (tDCS) in Food Cravings Control in Overweight/Obese Women', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'The Effect of Brain Neuromodulation on Food Cravings, Cognitive Control and Food Addiction Scales in Overweight/Obese Women Using tDCS', 'orgStudyIdInfo': {'id': 'IRB#15-001929'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tDCS and Go-No Go task', 'description': 'Certain randomly assigned participants will receive tDCS to the DLPFC for 8 daily 20-minute sessions, with a TDCS amplitude of 2 mAmps.\n\nDuring the tDCS session, individuals will perform a 10-min computerized Go-No Go task', 'interventionNames': ['Device: tDCS', 'Behavioral: Go-No GO task']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham brain stimulation and Go-No Go task', 'description': 'Certain randomly assigned participants will receive Sham Stimulation to the DLPFC for 8 daily 20-min sessions. The Sham stimulation is an inactive form of stimulation.\n\nDuring the sham brain stimulation session, individuals will perform a 10-min computerized Go-No Go task', 'interventionNames': ['Device: Sham brain stimulation', 'Behavioral: Go-No GO task']}], 'interventions': [{'name': 'tDCS', 'type': 'DEVICE', 'otherNames': ['Real brain stimulation'], 'description': 'Individuals undergo 20min daily sessions receiving actual tDCS to the brain (to the right DLPFC: dorsolateral prefrontal cortex)', 'armGroupLabels': ['tDCS and Go-No Go task']}, {'name': 'Sham brain stimulation', 'type': 'DEVICE', 'description': 'Individuals undergo 20min daily sessions receiving sham stimulation to the brain (to the right DLPFC: dorsolateral prefrontal cortex)', 'armGroupLabels': ['Sham brain stimulation and Go-No Go task']}, {'name': 'Go-No GO task', 'type': 'BEHAVIORAL', 'description': 'During the brain stimulation sessions, all individuals will be asked to perform a 10 min-computerized task related to inhibitory control (Go-No Go)', 'armGroupLabels': ['Sham brain stimulation and Go-No Go task', 'tDCS and Go-No Go task']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Claudia P Sanmiguel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Health Sciences Assistant Professor', 'investigatorFullName': 'Claudia P. Sanmiguel, MD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-06-24', 'type': 'RELEASE'}, {'date': '2023-07-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Claudia P. Sanmiguel, MD, Principal Investigator, University of California, Los Angeles'}}}}