Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-01-05 @ 11:41 PM
Study NCT ID:
NCT06426693
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2024-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Craving Network Neurofeedback
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2024-05-17', 'studyFirstSubmitQcDate': '2024-05-17', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in craving network strength during transfer runs', 'timeFrame': 'Week 1 and 3', 'description': 'Craving network strength will be measured during transfer (i.e., no feedback) runs and compared across scan sessions.'}, {'measure': 'Change in Food Craving Inventory Mean Score', 'timeFrame': 'Week 1, Week 7', 'description': 'Food Craving Inventory has 28 items rated 1-5 and overall mean is calculated, range 1-5 with higher score indicating higher craving. FCI will be compared between baseline and 1 month follow-up.'}, {'measure': 'Change in Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool Healthy Eating Index (HEI).', 'timeFrame': 'Week 1, Week 7', 'description': 'ASA-24 HEI is scored 0-100 with 100 indicating healthier diet and composite scores examined to interpret the overall score. HEI will be compared between baseline and 1 month follow-up.'}, {'measure': 'Change in craving network strength during resting state runs', 'timeFrame': 'Week 1 and 3', 'description': 'Craving network strength will be measured during resting state runs and compared across scan sessions.'}, {'measure': 'Change in Food Rating Task healthiness, tastiness, and choice scores', 'timeFrame': 'Week 1, Week 7', 'description': 'Food Rating Task outcomes include healthiness, tastiness, and choice. Healthiness and tastiness mean score is taken, range 1-5, with 5 indicating higher healthiness or tastiness. Choice is counted from 0-48 items choosing the food item over the neutral reference food item, with higher values indicating more frequent choice. Food Ratings will be compared between baseline and 1 month follow-up.'}, {'measure': 'Change in Food Snack Task caloric intake', 'timeFrame': 'Week 1 and 3', 'description': 'Food Snack Task will be used to measure caloric intake (out of a maximum value to calories offered) and compared across scan sessions.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight or Obesity']}, 'descriptionModule': {'briefSummary': 'This project tests whether individuals with overweight or obesity and high craving can learn to change their brain response to food cues using neurofeedback, to impact their craving and eating behavior.', 'detailedDescription': 'Aim 1 of this study is to test whether neurofeedback from the craving network is associated with reduced craving network strength.\n\nAim 2 of this study is to test whether neurofeedback from the craving network is associated with reduced food craving and changes in eating behavior.\n\nAim 3 of this study is to test whether neurofeedback from the craving network is associated with changes in resting state functional connectivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18 to 60 years\n* Body mass index \\>25 kg/m2\n* \\>2.37 Food Craving Inventory score\n\nExclusion Criteria:\n\n* Current or past 6 months use of anti-obesity medications\n* Weight-reduced state defined as \\>10% weight reduction in the past 6 months.\n* Nicotine use\n* Current diagnosis of neurological or psychiatric disorder\n* Obesity-related diseases such as type-2 diabetes\n* Contraindications to MRI\n* Baseline scanning with motion \\>0.15mm frame to frame displacement.'}, 'identificationModule': {'nctId': 'NCT06426693', 'briefTitle': 'Craving Network Neurofeedback', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Connectome-based Neurofeedback of the Craving Network to Reduce Food Cue Reactivity', 'orgStudyIdInfo': {'id': '2000037084'}, 'secondaryIdInfos': [{'id': '1R01DK136623-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK136623-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neurofeedback', 'description': 'Three imaging (fMRI) sessions of experimental feedback.', 'interventionNames': ['Device: Experimental feedback']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control neurofeedback', 'description': 'Three imaging (fMRI) sessions of sham feedback.', 'interventionNames': ['Device: Control feedback']}], 'interventions': [{'name': 'Experimental feedback', 'type': 'DEVICE', 'description': 'Participants provided with feedback of target brain activation patterns (e.g., thermometer) and will be instructed to try to change the feedback (e.g., decrease the thermometer).', 'armGroupLabels': ['Neurofeedback']}, {'name': 'Control feedback', 'type': 'DEVICE', 'description': 'Participants provided with control (sham, yoked to another participant) feedback (e.g., thermometer) and will be instructed to try to change the feedback (e.g., decrease the thermometer).', 'armGroupLabels': ['Control neurofeedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Yale MRRC Anlyan Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'centralContacts': [{'name': 'Kathleen A Garrison, PhD', 'role': 'CONTACT', 'email': 'kathleen.garrison@yale.edu', 'phone': '2037376232'}], 'overallOfficials': [{'name': 'Kathleen A Garrison, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'timeFrame': 'The research community will have access to data when the award ends.', 'ipdSharing': 'YES', 'description': 'Data will be findable for the research community through OpenNeuro and NITRC search functions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}