Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT05913518
Status:
RECRUITING
Last Update Posted:
2024-08-06
First Post:
2023-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neurofeedback Training of Metacognition in Subjects With Alcohol Use Disorder. Disorder Induces Neural Modifications: an Event-related Potentials Study
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-05', 'studyFirstSubmitDate': '2023-06-01', 'studyFirstSubmitQcDate': '2023-06-12', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event related potential', 'timeFrame': 'Baseline T0', 'description': 'Error related negativity (ERN) measurement'}, {'measure': 'Event related potential', 'timeFrame': 'Immediately after the last neurofeedback training session T1', 'description': 'Error related negativity (ERN) measurement'}, {'measure': 'Metacognition questionnaire-30 (MCQ-30)', 'timeFrame': 'Baseline T0', 'description': 'Metacognitive assessment by means of a questionnaire. Scores from 6 to 24, with higher scores meaning worse outcomes.'}, {'measure': 'Metacognition questionnaire-30 (MCQ-30)', 'timeFrame': 'Immediately after the last neurofeedback training session T1', 'description': 'Metacognitive assessment by means of a questionnaire. Scores from 6 to 24, with higher scores meaning worse outcomes.'}], 'secondaryOutcomes': [{'measure': 'Commission error rate', 'timeFrame': 'Baseline T0', 'description': 'Behavior assessment'}, {'measure': 'Commission error rate', 'timeFrame': 'Immediately after the last neurofeedback training session T1', 'description': 'Behavior assessment'}, {'measure': 'Reaction times', 'timeFrame': 'Baseline T0', 'description': 'Behavior assessment'}, {'measure': 'Abstinence', 'timeFrame': 'Immediately after the last neurofeedback training session T1', 'description': 'Number of days of abstinence'}, {'measure': 'Abstinence', 'timeFrame': '2 weeks post discharge', 'description': 'Number of days of abstinence'}, {'measure': 'Abstinence', 'timeFrame': '1 month post discharge', 'description': 'Number of days of abstinence'}, {'measure': 'Abstinence', 'timeFrame': '2 months post discharge', 'description': 'Number of days of abstinence'}, {'measure': 'Abstinence', 'timeFrame': '3 months post discharge', 'description': 'Number of days of abstinence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder']}, 'descriptionModule': {'briefSummary': 'Addressing cognitive deficits in alcohol use disorder (AUD) supports recovery. Impaired metacognitive functioning in AUD causes compromised recognition of the interoceptive state leading to the maintenance of alcohol abuse despite negative consequences. By promoting greater self-awareness and self-regulation, neurofeedback training is of high relevance in metacognition remediation to support abstinence.\n\nThe main objective of the present study is to validate neurofeedback as a complementary clinical tool to overcome metacognitive deficits that represent a significant factor in the maintenance of harmful consumption behavior and relapse phenomena in AUD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 and 65 years old undergoing a 3- to 4-week detoxification treatment program at the Alcohol Unit of CHU Brugmann hospital (Brussels, BELGIUM), who have been diagnosed with severe AUD (alcohol use disorder) according to the DSM-V-TR.\n\nExclusion Criteria:\n\n* history of neurological disorders\n* other serious medical conditions\n* neuroleptic treatment are excluded.'}, 'identificationModule': {'nctId': 'NCT05913518', 'briefTitle': 'Neurofeedback Training of Metacognition in Subjects With Alcohol Use Disorder. Disorder Induces Neural Modifications: an Event-related Potentials Study', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'Training Metacognition by Means of Neurofeedback in Subjects With Alcohol Use Disorder Induces Neural Modifications: an Event-related Potentials Study', 'orgStudyIdInfo': {'id': 'Neurofeedback'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active neurofeedback group', 'interventionNames': ['Device: Neurofeedback active']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo feedback group', 'interventionNames': ['Device: Neurofeedback placebo']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Neurofeedback active', 'type': 'DEVICE', 'description': 'Neurofeedback uses real-time displays of brain activity to teach self regulation of brain function. People can learn to control their own brain activity through operant conditioning, where they receive feedback on their brainwaves and learn to modify them to achieve a desired state. Active neurofeedback group aims at enhancing the sensorimotor rhythm (12-15 Hz).', 'armGroupLabels': ['Active neurofeedback group']}, {'name': 'Neurofeedback placebo', 'type': 'DEVICE', 'description': 'Neurofeedback uses real-time displays of brain activity to teach self regulation of brain function. People can learn to control their own brain activity through operant conditioning, where they receive feedback on their brainwaves and learn to modify them to achieve a desired state. Placebo feedback group (PFT) : patients enhance random frequency bands', 'armGroupLabels': ['Placebo feedback group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Salvatore Campanella', 'role': 'CONTACT', 'email': 'salvatore.campanella@chu-brugmann.be', 'phone': '3224772705'}, {'name': 'Salvatore Campanella', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Clémence Dousset', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Salvatore Campanella', 'role': 'CONTACT', 'email': 'salvatore.campanella@chu-brugmann.be', 'phone': '3224772705'}, {'name': 'Clémence Dousset', 'role': 'CONTACT', 'email': 'clemence.dousset@ulb.be'}], 'overallOfficials': [{'name': 'Salvatore Campanella', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Brugmann'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brugmann University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'FNRS Research Director', 'investigatorFullName': 'Salvatore Campanella', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}