[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616310":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":24,"responsibleParty":33,"collaborators":35,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":24,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":24,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":64,"whyStopped":24,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":24},{"fullName":5,"class":6},"Rhode Island Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ACB","EXPERIMENTAL","DBS of the anterior cingulate bundle (ACB)",[13],"Device: Medtronic Percept system and 3391 3387 Medtronic DBS electrodes",{"label":15,"type":10,"description":16,"interventionNames":17},"vALIC arms","DBS of the ventral anterior limb of the internal capsule (vALIC)",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Medtronic Percept system and 3391 3387 Medtronic DBS electrodes","Surgical implantation of deep brain stimulation electrodes with stimulation at one of two intracranial targets depending on randomization and crossover status.",[9,15],null,[26,31],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Owen Leary, BS","CONTACT","401-444-4362","memory.stimulation@lifespan.org",{"name":32,"role":28,"phone":29,"phoneExt":24,"email":30},"Darlene Gaudet, MS",{"type":34,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[36,38,40],{"name":37,"class":6},"Brown University",{"name":39,"class":6},"Baylor College of Medicine",{"name":41,"class":6},"Butler Hospital","100616310","deep-brain-stimulation-of-the-anterior-cingulate-bundle-acb-and-the-ventral-anterior-limb-of-the-internal-capsule-valic-in-patients-with-intractable-obsessive-compulsive-disorder-ocd-100616310",false,"NCT07303946","Deep Brain Stimulation of the Anterior Cingulate Bundle (ACB) and the Ventral Anterior Limb of the Internal Capsule (vALIC) in Patients With Intractable Obsessive Compulsive Disorder (OCD)","Double-Blind, Crossover, Feasibility Study of Deep Brain Stimulation of the Anterior Cingulate Bundle (ACB) and the Ventral Anterior Limb of the Internal Capsule (vALIC) in Patients With Intractable Obsessive Compulsive Disorder (OCD)","Inclusion Criteria:\n\n1. OCD, diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 30 and a Global Assessment of Functioning (GAF) score of 45 or less.\n2. Persistence of severe symptoms and impairment for five or more years despite at least three adequate (≥3 months at the maximum tolerated dose) serotonin transporter inhibitor trials (fluoxetine, sertraline, fluvoxamine, paroxetine, citalopram, escitalopram, or clomipramine) alone or in combination with ii. Adequate behavior therapy (≥20 sessions of expert exposure and response prevention), and iii. Augmentation of one of the selective SRIs with clomipramine, a neuroleptic, and clonazepam.\n3. Age between 21 and 65 years.\n4. Able to understand and comply with instructions.\n5. Able to give fully informed, written consent in the judgment of the site Consent Monitor.\n6. Either drug free or on a stable drug regimen for at least 6 weeks.\n7. Good general health.\n8. A family member or significant other, in contact with the patient every 1-3 days, is available and willing to communicate with the research team if the patient's clinical status worsens, and if necessary to accompany patients to study visits.\n9. The local referring psychiatrist is willing to provide ongoing care during and after the trial\n\nExclusion Criteria:\n\n1. personal\u002Ffamily history (1st\u002F2nd degree relatives) of schizophrenia or schizoaffective disorder, other primary psychotic disorder, bipolar disorder;\n2. present PTS;\n3. present acute suicidality or suicidal ideation;\n4. personal history of head injury, epilepsy, tic or other neurological disorders, neurodevelopmental (e.g., autism), systemic medical (metabolic, endocrine, chronic inflammatory, vascular, autoimmune) disease from medical records and self-report (all of which may confound interpretation of neuroimaging measures);\n5. MMSE score \\\u003C 24;\n6. premorbid IQ estimate \\\u003C 85;\n7. visual disturbance (\\\u003C20\u002F40 Snellen visual acuity, corrected);\n8. left\u002Fmixed handedness;\n9. current, or alcohol or illicit substance abuse\u002Fdependence in the last 3 months, determined by clinical assessment and urine toxicology;\n10. contraindications to MRI,: metallic foreign objects, e.g., aneurysm clips\u002Fpacemakers, or questionable history of metal fragments, claustrophobia raising the risk of panicking in enclosed spaces;\n11. positive pregnancy test for women of reproductive age, or women not using medically acceptable birth control throughout the study (barrier and\u002For oral contraceptives);\n12. current psychotic symptoms (potential confounding effect on neuroimaging measures; see above);\n13. an increased risk of seizure, determined by history;\n\n4\\) potentially proconvulsant medications (e.g., bupropion, tricyclic antidepressants, first-generation antipsychotics, lithium), and medications reducing cortical excitability (e.g., anticonvulsants, benzodiazepines, atypical antipsychotics).","ALL","21 Years","65 Years",{"count":53,"type":54},4,"ESTIMATED","INTERVENTIONAL",[57],"NA","This is a double blind pilot feasibility study, with a within subject crossover design of DBS of the anterior cingulate bundle(ACB) and the ventral anterior limb of the internal capsule(vALIC) in four patients with intractable OCD. Patients will be screened according to inclusion exclusion criteria listed above, approved by an independent Neuropsychiatric review board and informed consent obtained.",[60],"Obsessive-Compulsive Disorder",[62,63],"deep brain stimulation","intractable OCD","NOT_YET_RECRUITING","2025-12-23",{"date":67,"type":68},"2025-12-26","ACTUAL",{"date":70,"type":54},"2026-01",{"date":72,"type":54},"2031-01",{"name":5,"class":6}]