Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-02-02 @ 12:09 AM
Study NCT ID:
NCT02406456
Status:
COMPLETED
Last Update Posted:
2015-11-11
First Post:
2015-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimisation of Functional MRI-based Neurofeedback for Alcohol Use Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058765', 'term': 'Neurofeedback'}], 'ancestors': [{'id': 'D001676', 'term': 'Biofeedback, Psychology'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D030141', 'term': 'Feedback, Psychological'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-10', 'studyFirstSubmitDate': '2015-03-26', 'studyFirstSubmitQcDate': '2015-03-30', 'lastUpdatePostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurofeedback success (brain activation difference during neurofeedback and baseline blocks)', 'timeFrame': '1 day', 'description': "This measure will be based on the analysis of participants' fMRI (functional magnetic resonance imaging) data, reflecting brain activation, during exposure to alcohol cues. Neurofeedback success will be defined as significant difference between activation levels (expressed as beta weights of a linear regression model) during the regulation periods compared to baseline. The significance will be determined by a t-test."}], 'secondaryOutcomes': [{'measure': 'Drinking Urges Questionnaire as a measure of alcohol craving', 'timeFrame': '1 day', 'description': 'Measure of alcohol craving'}, {'measure': 'Alcohol Stroop task as a measure of cognitive bias', 'timeFrame': '1 day', 'description': 'Measure of cognitive bias'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alcohol Abuse']}, 'descriptionModule': {'briefSummary': 'Participants will undergo a single session of functional magnetic resonance imaging (fMRI)-based neurofeedback (approximately 1 hour). The investigators will assess their ability to regulate motivational networks of the brain during the exposure to alcohol cues and evaluate immediate effects on craving and cognitive bias for alcohol by administering a questionnaire and a Stroop task before and after the session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of alcohol use disorder or current alcohol consumption above 21 units (1 unit = 8g) of alcohol per week (male participants) or above 14 units of alcohol per week (female participants)\n\nExclusion Criteria:\n\n* MRI safety exclusion criteria'}, 'identificationModule': {'nctId': 'NCT02406456', 'briefTitle': 'Optimisation of Functional MRI-based Neurofeedback for Alcohol Use Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Cardiff University'}, 'officialTitle': 'Real-time fMRI Neurofeedback as a Treatment Tool for Alcohol Dependence - Protocol Optimisation Phase', 'orgStudyIdInfo': {'id': 'BRAINTRAINPILOT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neurofeedback', 'interventionNames': ['Other: Neurofeedback']}], 'interventions': [{'name': 'Neurofeedback', 'type': 'OTHER', 'armGroupLabels': ['Neurofeedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF14 4XN', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'School of Medicine, Cardiff University', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'overallOfficials': [{'name': 'David Linden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiff University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiff University', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Commission', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Translational Neuroscience', 'investigatorFullName': 'David Linden', 'investigatorAffiliation': 'Cardiff University'}}}}