[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539795":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":39,"centralContacts":50,"locations":56,"responsibleParty":75,"collaborators":79,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":34,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":34,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":34,"overallStatus":59,"whyStopped":34,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Active transcutaneous vagus nerve stimulation","ACTIVE_COMPARATOR","The tVNS device consisted of two titan electrodes mounted on a gel frame and connected to a wired neurostimulation device (tVNS Health GmbH, Germany). Electrodes were placed on the cymba conchae. Stimulation intensity of 0.5 mA, delivered with a pulse width of 200-300 μs at 25 Hz.",[13],"Device: Transcutaneous vagus nerve stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham transcutaneous vagus nerve stimulation","SHAM_COMPARATOR","Stimulation parameters equivalent to active but sham stimulation was administered by positioning the electrodes on the central part of the left earlobe rather than the outer auditory canal, as the earlobe lacks vagus innervation.",[13],{"label":20,"type":10,"description":21,"interventionNames":22},"Closed-loop AM-tACS increase frontal midline theta oscillation","We will deliver amplitude-modulated transcranial alternating current stimulation (AM-tACS) using two circular rubber electrodes (4 cm diameter) positioned at the Fpz and Cz locations of the international 10-20 system. The AM-tACS stimulation waveform features a carrier signal frequency of 10 kHz, an amplitude of ±1 mA, and a signal that is real-time synchronized with theta oscillations of the frontal midline. In the active condition target oscillations (frontal midline theta) will be increased.",[23],"Device: Closed-loop AM-tACS",{"label":25,"type":16,"description":26,"interventionNames":27},"Closed-loop AM-tACS decrease frontal midline theta oscillation","Equivalent to the active comparator - except here the target oscillation will be suppressed.",[23],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DEVICE","Transcutaneous vagus nerve stimulation","Patients that are enrolled in a MBRP program will be subjected to weekly tVNS stimulation during a 30-minute audio guided mindfulness exercise.",[9,15],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Closed-loop AM-tACS","Patients that are enrolled in a MBRP program will be subjected to weekly CLAM-tACS stimulation during a 30-minute audio guided mindfulness exercise.",[25,20],[40,44,47],{"name":41,"affiliation":42,"role":43},"Anne Beck, Prof. Dr.","Faculty of Health Sciences, Health and Medical University, University of Potsdam, Potsdam, Germany","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":46,"role":43},"Nina Romanczuk-Seiferth, Prof. Dr.","Department of Psychology, Clinical Psychology and Psychotherapy, MSB Medical School Berlin, Berlin, Germany",{"name":48,"affiliation":49,"role":43},"Surjo Soekadar, Prof. Dr.","Department of Psychiatry and Psychotherapy, Charité - Berlin University of Medicine, Berlin, Germany",[51],{"name":52,"role":53,"phone":54,"phoneExt":34,"email":55},"Annika Rosenthal","CONTACT","030 450 517040","annika.rosenthal@charite.de",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Charité - Berlin University of Medicine","RECRUITING","Berlin","State of Berlin","10117","Germany","DE",{"type":66,"coordinates":67},"Point",[68,69],13.41053,52.52437,{"lat":69,"lon":68},[72],{"name":73,"role":53,"phone":74,"phoneExt":34,"email":34},"Rosenthal","0049 30 450 517040",{"type":43,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":78,"oldNameTitle":34,"oldOrganization":34},"Anne Beck","Prof. Dr. Anne Beck","Health and Medical University Potsdam",[80],{"name":81,"class":6},"Medical School Berlin","100539795","neuromodulation-and-mindfulness-patients-with-aud-100539795",false,"NCT06308484","Neuromodulation and Mindfulness Patients With AUD","Neuromodulation and Mindfulness as Therapeutic Treatment in Detoxified Patients With AUD","Inclusion Criteria:\n\n* Alcohol Dependence (ICD-10)\n* abstinence between 3 days and 12 months\n\nExclusion Criteria:\n\n* current (last 12 months) substance use disorder\u002Fdependence\n* neurological disorders (e.g. epilepsy, neuropathy, multiple sclerosis)\n* current severe major depressive disorder, manic episode or schizophreniform disorder\n* intake of anticonvulsive or high-potency antipsychotic medication","ALL","18 Years","70 Years",{"count":93,"type":94},140,"ESTIMATED","INTERVENTIONAL",[97],"NA","Our primary objective is to integrate tVNS and mindfulness meditation within a structured mindfulness-based relapse prevention (MBRP) program for detoxified alcohol-dependent patients (AD). We aim to determine whether neuromodulation can enhance mindfulness-based relapse prevention compared to mindfulness practice alone. In this context, we will investigate potential changes in the interaction of top-down control and cue reactivity, as well as assess the severity of AUD. Measurements of drinking behavior, cravings, and abstinence rates will be conducted up to three months post-treatment. Our second objective is to examine the causal role of frontal midline theta oscillations (FMΘ) in MBRP and cognitive control. To achieve this, we will first establish closed-loop amplitude-modulated transcranial alternating current stimulation (CLAM-tACS) to selectively modulate FMΘ oscillations during MBRP meditation exercises in AUD patients (2).",[100],"Alcohol Dependence","2026-03-18",{"date":103,"type":104},"2026-03-20","ACTUAL",{"date":106,"type":104},"2024-03-20",{"date":108,"type":94},"2027-06-30",{"name":5,"class":6},1]