[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597907":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":30,"locations":39,"responsibleParty":67,"collaborators":20,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":20,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":42,"whyStopped":20,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Goethe University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Frontopolar cTBS Intervention","EXPERIMENTAL","Participants in this arm will receive 15 sessions of continuous theta burst stimulation (cTBS) over the left frontopolar cortex across 5 consecutive days (3 sessions\u002Fday) using neuronavigation based on individual MRI. The stimulation intensity is set at 110% of the resting motor threshold. Virtual Reality Cue Exposure and Craving Assessment (VR-CECA) and psychological craving assessment will be performed before and after the TMS intervention. Baseline structural and functional MRI scans will be acquired before stimulation for brain connectivity analysis.",[13],"Device: Transcranial Magnetic Stimulation (TMS)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Transcranial Magnetic Stimulation (TMS)","Patients will receive cTBS, a five-minute protocol with inhibitory effects over the left frontal pole, using an accelerated design comprising three sessions daily for five consecutive days (15 sessions total). Stimulation will be delivered using a Magventure TMS device routinely used in clinical practice at the Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital Frankfurt. TMS is generally well tolerated, with mild headache or scalp discomfort as common side effects. Localization will be based on individual MRI data: after cortical parcellation with FreeSurfer 7.4.1, the left frontal pole centroid will be extracted. Coil placement will be neuronavigated using the Localite Neuronavigator. Stimulation will be applied at 110% resting motor threshold (rMT; 3-pulse bursts at 50 Hz, 5 Hz interburst; 1800 pulses\u002Ftrain; 60 s intertrain). Intensity may be gradually increased until 110% rMT is reached.",[9],null,[22,26,28],{"name":23,"affiliation":24,"role":25},"Jonathan Repple, Prof. Dr.","Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":24,"role":25},"Mathias Luderer, Dr. med.",{"name":29,"affiliation":24,"role":25},"Maren Schmidt-Kassow, Prof. Dr.",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":20,"email":35},"Franka Timm, M.Sc.","CONTACT","+49 171 9225424","f.timm@med.uni-frankfurt.de",{"name":23,"role":33,"phone":37,"phoneExt":20,"email":38},"+49 17641633481","repple@em.uni-frankfurt.de",[40,54],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":20},"Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt, Goethe-Universität","RECRUITING","Frankfurt am Main","Hesse","60528","Germany","DE",{"type":49,"coordinates":50},"Point",[51,52],8.68417,50.11552,{"lat":52,"lon":51},{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":55,"geoPoint":57,"contacts":58},{"type":49,"coordinates":56},[51,52],{"lat":52,"lon":51},[59,62,63,64,65],{"name":60,"role":33,"phone":61,"phoneExt":20,"email":35},"Franka Timm","+491719225424",{"name":23,"role":33,"phone":37,"phoneExt":20,"email":38},{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"name":27,"role":25,"phone":20,"phoneExt":20,"email":20},{"name":29,"role":66,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"type":25,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Jonathan Repple","Prof. Dr.","100597907","effects-of-frontopolar-tms-in-alcohol-craving-100597907",false,"NCT07064590","Effects of Frontopolar TMS in Alcohol Craving","Investigation of Frontopolar Transcranial Magnetic Stimulation on Correlates of Craving in Alcohol Addiction","TMS-SUD","Inclusion Criteria:\n\n* adults aged 18-65\n* ICD-10 diagnosis of alcohol dependence\n* Ability to give consent\n* Sinus rhythm in ECG\n\nExclusion Criteria:\n\n* Current psychotic symptoms in patients with psychotic disorders (F20, F23, F10.5)\n* Contraindication against TMS or MRI\n* Severe neurological disorders such as epilepsy, stroke, neuroinflammatory disorders (e.g., multiple sclerosis). A history of seizures only in the context of alcohol withdrawal does not represent a contraindication, unless the seizure happened in the last 3 weeks before study inclusion.\n* Acute withdrawal symptoms (CIWA-Ar \\> 5)","ALL","18 Years","65 Years",{"count":82,"type":83},34,"ESTIMATED","INTERVENTIONAL",[86],"NA","The goal of this interventional study is to learn if continuous theta burst stimulation (cTBS) applied over the left frontopolar cortex can reduce psychological, physiological, and neurobiological markers of alcohol craving in patients with alcohol dependence (AD).\n\nThe main questions it aims to answer are:\n\n* Does cTBS over the left frontopolar cortex reduce psychological and physiological measures of alcohol craving in individuals with AD?\n* Are baseline structural and functional brain connectivity patterns associated with individual differences in cTBS-induced changes in craving?\n\nThe participants will:\n\n* Receive cTBS over the left frontopolar cortex using an accelerated protocol comprising 15 TMS-sessions on five consecutive days\n* Undergo psychological and physiological assessments of alcohol craving before and after the TMS intervention\n* Complete magnetic resonance imaging (MRI) sessions to assess baseline brain structural and functional connectivity\n\nThis study aims to advance the understanding of the neurophysiological mechanisms underlying craving in AD and the identification of potential biomarkers for predicting psychological and physiological craving reductions.",[89],"Alcohol Addiction",[91,92,93,94,95,96,97,98,99,100,101,102,103,104,105],"frontopolar transcranial magnetic stimulation (TMS)","craving","alcohol addiction","addiction treatment","virtual reality (VR)","magnetic resonance imaging (MRI)","Continuous Theta Burst Stimulation (cTBS)","neuromodulation","structural and functional brain connectivity","connectome","neurophysiological craving markers","prediction","physiological craving markers","psychological craving markers","Neuronavigation","2026-01-19",{"date":108,"type":109},"2026-01-22","ACTUAL",{"date":111,"type":109},"2025-05-16",{"date":113,"type":83},"2027-05",{"name":5,"class":6},2]