[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619177":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":37,"centralContacts":37,"locations":50,"responsibleParty":108,"collaborators":111,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":37,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":53,"whyStopped":37,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"University of Cambridge","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Dual Stimulation (Nucleus Accumbens + Ventral Internal Capsule)","EXPERIMENTAL","Participants receive active deep brain stimulation simultaneously targeting both the nucleus accumbens and the ventral internal capsule.",[13],"Device: Dual-Target Deep Brain Stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Single Stimulation - Nucleus Accumbens Only","ACTIVE_COMPARATOR","Participants receive active deep brain stimulation targeting the nucleus accumbens only, with ventral internal capsule stimulation inactive.",[19],"Device: Nucleus Accumbens Deep Brain Stimulation",{"label":21,"type":16,"description":22,"interventionNames":23},"Single Stimulation - Ventral Internal Capsule Only","Participants receive active deep brain stimulation targeting the ventral internal capsule only, with nucleus accumbens stimulation inactive.",[24],"Device: Ventral Internal Capsule Deep Brain Stimulation",{"label":26,"type":27,"description":28,"interventionNames":29},"Sham Stimulation (Inactive)","SHAM_COMPARATOR","Participants receive sham (inactive) deep brain stimulation. The implanted device is turned off; no therapeutic stimulation is provided.",[30],"Device: Sham Deep Brain Stimulation",[32,38,42,46],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DEVICE","Dual-Target Deep Brain Stimulation","A surgically implanted deep brain stimulation (DBS) system delivers active stimulation simultaneously to the nucleus accumbens and the ventral internal capsule. Stimulation parameters are based on individualized optimization performed prior to randomization and remain constant throughout this condition.",[9],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Nucleus Accumbens Deep Brain Stimulation","A surgically implanted deep brain stimulation (DBS) system delivers active stimulation to the nucleus accumbens only. Ventral internal capsule stimulation is inactive. Stimulation parameters are based on individualized optimization performed prior to randomization and remain constant throughout this condition.",[15],{"type":33,"name":43,"description":44,"armGroupLabels":45,"otherNames":37},"Ventral Internal Capsule Deep Brain Stimulation","A surgically implanted deep brain stimulation (DBS) system delivers active stimulation to the ventral internal capsule only. Nucleus accumbens stimulation is inactive. Stimulation parameters are based on individualized optimization performed prior to randomization and remain constant throughout this condition.",[21],{"type":33,"name":47,"description":48,"armGroupLabels":49,"otherNames":37},"Sham Deep Brain Stimulation","A surgically implanted deep brain stimulation (DBS) system is present but no therapeutic stimulation is delivered during this condition. All stimulation remains inactive.",[26],[51,87],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Cambridge University Hospitals (Addenbrooke's Hospital)","RECRUITING","Cambridge","Cambridgeshire","CB2 0QQ","United Kingdom","UK",{"type":60,"coordinates":61},"Point",[62,63],0.11667,52.2,{"lat":63,"lon":62},[66,71,74,76,78,81,83,85],{"name":67,"role":68,"phone":69,"phoneExt":37,"email":70},"Samantha N Sallie, PhD","CONTACT","01223 245151","info@brain-pacer.com",{"name":72,"role":73,"phone":37,"phoneExt":37,"email":37},"Valerie Voon, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":75,"role":73,"phone":37,"phoneExt":37,"email":37},"Peter Hutchinson, PhD, FRCS",{"name":77,"role":73,"phone":37,"phoneExt":37,"email":37},"John Strang, MBBS, FRCPsych, FRCP, MD",{"name":79,"role":80,"phone":37,"phoneExt":37,"email":37},"Harry Bulstrode, BMBCh, PhD, FRCSI","SUB_INVESTIGATOR",{"name":82,"role":80,"phone":37,"phoneExt":37,"email":37},"Jonathon Wood, MBChB, MRCPsych",{"name":84,"role":80,"phone":37,"phoneExt":37,"email":37},"David Christmas, MBChB, MD, MRCPsych",{"name":86,"role":80,"phone":37,"phoneExt":37,"email":37},"Robert Morris, MA, MBChB, FRCS",{"facility":88,"status":53,"city":89,"state":90,"zip":91,"country":57,"countryCode":58,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"King's College Hospital","London","Greater London","SE5 9RS",{"type":60,"coordinates":93},[94,95],-0.12574,51.50853,{"lat":95,"lon":94},[98,102,104,106],{"name":99,"role":68,"phone":100,"phoneExt":37,"email":101},"Peter Kosa, MBBS","02032999000","peter.kosa@nhs.net",{"name":103,"role":73,"phone":37,"phoneExt":37,"email":37},"David Okai, MD, MRCPsych",{"name":105,"role":73,"phone":37,"phoneExt":37,"email":37},"Keyoumars Ashkan, MBE",{"name":107,"role":80,"phone":37,"phoneExt":37,"email":37},"Nicola Kalk, MBChB, MRCPsych, PhD",{"type":73,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Valerie Voon","Professor Valerie Voon, Professor of Neuropsychiatry and Neuromodulation, Department of Psychiatry, University of Cambridge",[112,114],{"name":113,"class":6},"Cambridge University Hospitals NHS Foundation Trust",{"name":115,"class":6},"King's College Hospital NHS Trust","100619177","deep-brain-stimulation-to-understand-and-treat-addiction-100619177",false,"NCT07341230","Deep Brain Stimulation to Understand and Treat Addiction","Deep Brain Stimulation for Disorders of Addiction: Mechanisms and a Pilot Blinded Randomized Cross-over Placebo Controlled Trial","Brain-PACER","Inclusion Criteria:\n\n* Adults aged 18 to 60 years\n* Diagnosed with Alcohol Use Disorder (AUD) according to DSM-5 criteria\n* Primary diagnosis of treatment-refractory AUD (comorbid nicotine dependence, other psychoactive substance use disorders, moderate major depressive disorder, anxiety disorders or obsessive-compulsive disorder are permissible if AUD is principal)\n* Disorder duration of AUD ≥ 5 years\n* At least 3 unsuccessful attempts at achieving abstinence\n* Failed prior psychotherapy and standard pharmacotherapy for AUD\n* Medically and neurologically suitable for surgery and MRI-compatible\n* Capable of providing informed consent and willing to comply with study procedures\n\nExclusion Criteria:\n\n* Severe psychiatric disorder other than Alcohol Use Disorder (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)\n* Severe major depressive disorder (moderate depression acceptable)\n* Current active suicidal ideation or history of serious suicide attempts\n* Previous treatment with electroconvulsive therapy (ECT)\n* Presence of implanted electrical devices, including:\n* Cardiac pacemaker or defibrillator (or clinical indication for pacemaker placement)\n* Implanted vagus nerve stimulator (VNS)\n* Any other chronically implanted neurostimulation device\n* Significant neurological history, including prior hemorrhagic or ischemic stroke, subarachnoid hemorrhage, or other major neurological illness\n* Any significant medical condition that, in the opinion of the clinical team, would increase surgical or anesthetic risk\n* Current pregnancy\n* Contraindications to deep brain stimulation or neurosurgery, including:\n* Inability to tolerate general anesthesia (as assessed by anesthesiology)\n* Increased risk of bleeding (as determined by hepatology\u002Fhematology review)\n* History of coagulopathy\n* Current or previous anticoagulant use\n* Uncontrolled hypertension (controlled hypertension with medication is acceptable)\n* Stage 4 liver cirrhosis\n* History of major cardiac arrhythmia (e.g., atrial fibrillation) or need for anti-arrhythmic medication\n* History of requiring cardioversion\n* History of repeated falls\n* History of major head injury\n* Marked cognitive impairment\n* Seizure history, including multiple alcohol withdrawal seizures\n* Marked cortical atrophy on neuroimaging\n* Inadequate logistical or social support that would impair the safe conduct of deep brain stimulation therapy, including inability to reliably attend scheduled visits, lack of reasonable access to the study site, or inadequate home or caregiver support necessary for postoperative care, device management and follow-up.","ALL","18 Years","60 Years",{"count":128,"type":129},9,"ESTIMATED","INTERVENTIONAL",[132],"NA","This study is testing whether deep brain stimulation (DBS) can safely help people with severe alcohol use disorder who have not improved with standard treatments. DBS uses small electrical signals to change activity in brain areas linked to craving, self-control, and emotion. The study will test whether this treatment can reduce how often people drink and how much they drink each day. Researchers will also record brain activity to better understand how DBS affects craving and relapse.",[135],"Alcohol Use Disorder",[137,138,139],"Alcohol use disorder (AUD)","Deep brain stimulation (DBS)","Addiction","2026-03-22",{"date":142,"type":143},"2026-03-24","ACTUAL",{"date":145,"type":143},"2025-07-01",{"date":147,"type":129},"2027-10-31",{"name":5,"class":6},2]