[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487012":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":57,"centralContacts":61,"locations":67,"responsibleParty":84,"collaborators":87,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":35,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":69,"whyStopped":35,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Auburn University","OTHER",[8,15,21,26,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Neurofeedback-active + TMS-active","EXPERIMENTAL","4 sessions of: TMS (protocol: 10 Hz pulses delivered at 110% of MT in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of own brain activity from multiple ROIs measured using fMRI)",[13,14],"Behavioral: Realtime fMRI Neurofeedback - Active","Device: TMS - Active",{"label":16,"type":17,"description":18,"interventionNames":19},"Neurofeedback-active + TMS-sham","ACTIVE_COMPARATOR","4 sessions of: TMS (protocol: 10 Hz pulses delivered using the Sham TMS coil in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of own brain activity from multiple ROIs measured using fMRI)",[13,20],"Device: TMS - Sham",{"label":22,"type":17,"description":23,"interventionNames":24},"Neurofeedback-sham + TMS-active","4 sessions of: TMS (protocol: 10 Hz pulses delivered at 110% of MT in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of other's brain activity from multiple ROIs measured using fMRI)",[14,25],"Behavioral: Realtime fMRI Neurofeedback - Yoked Sham",{"label":27,"type":28,"description":29,"interventionNames":30},"Neurofeedback-sham + TMS-sham","SHAM_COMPARATOR","4 sessions of: TMS (protocol: 10 Hz pulses delivered using the Sham TMS coil in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of other's brain activity from multiple ROIs measured using fMRI)",[25,20],{"label":32,"type":33,"description":34,"interventionNames":35},"Check-In Only","NO_INTERVENTION","4 sessions of: Completing typical pre-TMS\u002FMRI procedures Being prompted to reflect on outside treatment (TAU)",null,[37,42,49,53],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":35},"BEHAVIORAL","Realtime fMRI Neurofeedback - Active","fMRI aided reinforcement of craving regulation",[9,16],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"DEVICE","TMS - Active","rTMS to right dorsolateral prefrontal cortex to reduce craving",[9,22],[48],"Magventure Magpro",{"type":38,"name":50,"description":51,"armGroupLabels":52,"otherNames":35},"Realtime fMRI Neurofeedback - Yoked Sham","Display of feedback from other participant's sessions to serve as a sham for fMRI aided reinforcement of craving regulation",[22,27],{"type":43,"name":54,"description":55,"armGroupLabels":56,"otherNames":35},"TMS - Sham","rTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex",[16,27],[58],{"name":59,"affiliation":5,"role":60},"Samantha J Fede, PhD","PRINCIPAL_INVESTIGATOR",[62],{"name":63,"role":64,"phone":65,"phoneExt":35,"email":66},"SCAMPI Lab","CONTACT","334-521-2807","scampi@auburn.edu",[68],{"facility":5,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"RECRUITING","Auburn","Alabama","36849","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-85.48078,32.60986,{"lat":79,"lon":78},[82,83],{"name":63,"role":64,"phone":65,"phoneExt":35,"email":66},{"name":59,"role":60,"phone":35,"phoneExt":35,"email":35},{"type":60,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Samantha Fede","Assistant Professor",[88],{"name":89,"class":90},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100487012","a-combined-neurofeedback-tms-intervention-for-alcohol-use-disorder-100487012",false,"NCT05621538","A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder","CNT","Inclusion Criteria:\n\n1. Age 19-65\n2. Receiving treatment for Alcohol Use Disorder\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","ALL","19 Years","65 Years",{"count":102,"type":103},90,"ESTIMATED","INTERVENTIONAL",[106],"NA","The goal of this clinical study is to test the effectiveness of a supplemental fMRI neurofeedback and\u002For TMS intervention in individuals seeking treatment for Alcohol Use Disorder.\n\nAfter an initial visit, participants will come in once a week for four (4) weeks for an intervention session, which may or may not include TMS and MRI. Participants will be contacted for monthly follow-ups (remotely) for up to 12 months and will be asked to come in for two MRI follow-ups at 6 and 12 months.",[109],"Alcohol Use Disorder",[111,112,113,114,115,116,117],"treatment seeking","alcohol","TMS","neurofeedback","supplemental intervention","heavy drinking","problems with drinking","2025-10-02",{"date":120,"type":121},"2025-10-07","ACTUAL",{"date":123,"type":121},"2025-10-01",{"date":125,"type":103},"2026-03-31",{"name":5,"class":6},1]