Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT05611502
Status:
RECRUITING
Last Update Posted:
2025-10-07
First Post:
2022-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of TMS on Attention Modulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D063425', 'term': 'Binge Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants will be randomly assigned to receive each arm in counterbalanced order (AB or BA).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-11-03', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in attention switching', 'timeFrame': 'Baseline, immediately following TMS A, immediately following TMS B', 'description': 'MRI Task- analysis of behavioral data'}, {'measure': 'Change in sociomoral attention switching', 'timeFrame': 'Baseline, immediately following TMS A, immediately following TMS B', 'description': 'MRI Task- analysis of behavioral data'}, {'measure': 'Change in cue reactivity', 'timeFrame': 'Baseline, immediately following TMS A, immediately following TMS B', 'description': 'MRI Task- analysis of behavioral data'}], 'secondaryOutcomes': [{'measure': 'Change in brain activity attention switching', 'timeFrame': 'Baseline, immediately following TMS A, immediately following TMS B', 'description': 'MRI Task- analysis of imaging (fMRI) data'}, {'measure': 'Change in brain activity during sociomoral attention switching', 'timeFrame': 'Baseline, immediately following TMS A, immediately following TMS B', 'description': 'MRI Task- analysis of imaging (fMRI) data'}, {'measure': 'Change in brain activity during cue reactivity', 'timeFrame': 'Baseline, immediately following TMS A, immediately following TMS B', 'description': 'MRI Task- analysis of imaging (fMRI) data'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['alcohol', 'attention', 'TMS', 'binge drinking', 'emotion', 'social cognition', 'moral', 'MRI', 'frontal eye fields', 'moral cognition'], 'conditions': ['Drinking, Alcohol']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to help understand how attention processes influence brain engagement during emotion and social cognition. The investigators also want to know if these processes are associated with drinking alcohol.\n\nParticipation includes three study visits of about 2 hours each over approximately a month. The first visit involves a magnetic resonance imaging (MRI) scan and answering survey questions. Each of the next two visits will involve a session of transcranial magnetic stimulation (TMS, a non-invasive brain stimulation technique) followed by another MRI scan.\n\nPeople in the Auburn/Opelika area 19 or older are eligible to participate. People who drink alcohol and people who do not drink or don't drink very much are invited to participate."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Age 18 or Older\n\n2A. (Drinker Group): Reports consuming 4 \\[if female\\]/ 5 \\[if male\\] or more standard drinks on one occasion at least 2 times a month AND/OR reports consuming more than 7 \\[if female\\]/ 14 \\[if male\\] standard drinks per week on average\n\n2B. (Healthy Volunteer Group): Reports consuming 4 \\[if female\\]/ 5 \\[if male\\] or more standard drinks on one occasion less than once a month AND reports consuming less than 7 \\[if female\\]/ 14 \\[if male\\] standard drinks per week on average\n\nExclusion Criteria:\n\n1. MRI Contraindications\n\n 1. Presence of metal in the body that would make having a 7T MRI unsafe (including facial tattoos)\n 2. Claustrophobia, such that individual would be unable to stay in the MRI for up to 1 hr\n 3. Hearing loss, including tinnitus, that might be made worse by MRI or TMS\n2. TMS Contraindications\n\n 1. Has ever had a seizure, or has a family history of epilepsy\n 2. Taking medications or substances that lower the seizure threshold\\*\n 3. Implanted devices that are in the head or rely on physiological signals\n 4. History of neurological disease, such as stroke or brain tumor\n 5. Head injury with loss of consciousness greater than 30 minutes\n 6. Actively withdrawing from alcohol\n3. Family history of schizophrenia or presence of psychotic symptoms'}, 'identificationModule': {'nctId': 'NCT05611502', 'acronym': 'TAM', 'briefTitle': 'Influence of TMS on Attention Modulation', 'organization': {'class': 'OTHER', 'fullName': 'Auburn University'}, 'officialTitle': 'A Combined Neurofeedback- TMS Intervention for Alcohol Use Disorder - Aim 2', 'orgStudyIdInfo': {'id': '21510'}, 'secondaryIdInfos': [{'id': 'R00AA027830', 'link': 'https://reporter.nih.gov/quickSearch/R00AA027830', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TMS A', 'description': 'TMS administered over right frontal eye field at 10 Hz, 110% of MT, 60 x 5 sec trains, 25 sec ITI', 'interventionNames': ['Device: TMS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TMS B', 'description': 'TMS administered over right frontal eye field at 1 Hz, 110% of MT, 7 x 225 sec trains, 30 sec ITI', 'interventionNames': ['Device: TMS']}], 'interventions': [{'name': 'TMS', 'type': 'DEVICE', 'otherNames': ['Magventure MagPro'], 'description': 'TMS will be administered in a pattern that is either excitatory or inhibitory.', 'armGroupLabels': ['TMS A', 'TMS B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36849', 'city': 'Auburn', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'SCAMPI Lab', 'role': 'CONTACT', 'email': 'scampi@auburn.edu', 'phone': '334-521-2807'}, {'name': 'Samantha J Fede, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Auburn University', 'geoPoint': {'lat': 32.60986, 'lon': -85.48078}}], 'centralContacts': [{'name': 'SCAMPI Lab', 'role': 'CONTACT', 'email': 'scampi@auburn.edu', 'phone': '334-521-2807'}], 'overallOfficials': [{'name': 'Samantha J Fede, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'ipdSharing': 'YES', 'description': 'Data will be shared through the NIAAA Data Archive according to standard NIAAA procedures. This will include deidentified behavioral, self-report, and imaging data.\n\nParticipants will have the option to opt out of having their individual data available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Auburn University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Samantha Fede', 'investigatorAffiliation': 'Auburn University'}}}}