[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03918577":3,"trial-entities:NCT03918577":96,"trial-summary:NCT03918577":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":24,"primary_purpose":13,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":36,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":44,"healthy_volunteers":14,"eligibility_criteria":45,"std_ages":57,"locations":60,"central_contacts":80,"overall_officials":85,"references":88,"see_also_links":89},"NCT03918577","45068","Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders","RECRUITING","2026-12-30","2026-01","2026-01-22","2022-05-10","Stanford University","OTHER",false,"This study investigates whether caloric vestibular stimulation can modulate a measure of insight in obsessive-compulsive spectrum disorders.","Obsessive-compulsive and related disorders (OCRD), including obsessive compulsive disorder and body dysmorphic disorder, are chronic and disabling conditions characterized by recurrent intrusive thoughts and associated compulsive behaviors that affect millions of individuals in the US each year. Individuals affected by OCRD differ in insight, or the degree to which they understand their intrusive thoughts to reflect illness. Impairments in insight limit individuals' motivation to engage in care and predict worse outcome in those who access treatment.\n\nThis study seeks to explore whether unilateral stimulation of the vestibular system, which activates cortical areas hypothesized to underlie clinical insight, may beneficially modulate insight in individuals with OCRD.",[18,19,20],"Obsessive-Compulsive Disorder","Body Dysmorphic Disorders","Illness Anxiety Disorder",[22,23],"Caloric Vestibular Stimulation","Insight","INTERVENTIONAL",[26],"NA",{"count":28,"type":29},16,"ESTIMATED",[31],{"type":13,"name":22,"description":32,"armGroupLabels":33},"Cold water creates a convection current in the semicircular canal of the vestibular apparatus, leading to brief (\\\u003C3 min) and typically well tolerated sense of rotational movement. Similar stimulation is routinely used in standard vestibular diagnostic testing.",[34,35],"left cold caloric vestibular stimulation","right cold caloric vestibular stimulation",[37],{"measure":38,"description":39,"timeFrame":40},"change in clinical insight as measured by the Brown Assessment of Beliefs (BABS).","Changes in clinical insight will be rated using the BABS, a gold-standard measure for assessing multiple dimensions of clinical insight across psychiatric disorders. The BABS is a 24 point scale for which scores ≥13 suggest poor or absent insight.","1 hour",[],"ALL","18 Years","65 Years",{"inclusion":46,"exclusion":52,"raw_text":56},[47,48,49,50,51],"Age 18-65","Primary diagnosis of Obsessive-Compulsive Disorder, Body Dysmorphic Disorder, Illness Anxiety Disorder or Somatic Symptom Disorder (excluding \"with predominant pain\")","Strongly held OCRD-related concerns meeting BABS score criterion.","No recent change in psychopharmacological treatment, if any","Capacity to provide informed consent",[53,54,55],"Psychiatric or medical conditions (eg, vertigo, history of otological surgery) that might make participation unsafe","Pregnant or nursing women","Active or recent substance use","Inclusion Criteria:\n\n* Age 18-65\n* Primary diagnosis of Obsessive-Compulsive Disorder, Body Dysmorphic Disorder, Illness Anxiety Disorder or Somatic Symptom Disorder (excluding \"with predominant pain\")\n* Strongly held OCRD-related concerns meeting BABS score criterion.\n* No recent change in psychopharmacological treatment, if any\n* Capacity to provide informed consent\n\nExclusion Criteria:\n\n* Psychiatric or medical conditions (eg, vertigo, history of otological surgery) that might make participation unsafe\n* Pregnant or nursing women\n* Active or recent substance use",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":12,"status":7,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":77},"Stanford","California","94304","United States",[67,72,74],{"name":68,"role":69,"phone":70,"email":71},"Pavithra Makunda, MS","CONTACT","650-723-4095","ocdresearch@stanford.edu",{"name":73,"role":69,"phone":70,"email":71},"Sindu Menon, MBBS",{"name":75,"role":76},"Peter van Roessel, MD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":78,"lon":79},37.42411,-122.16608,[81,83],{"name":82,"role":69,"phone":70,"email":71},"Pavithra Mukunda, MS",{"name":84,"role":69,"phone":70,"email":71},"Maria Filippou-Frye, MD, MBS",[86],{"name":87,"affiliation":12,"role":76},"Peter J van Roessel, MD, PhD",[],[90,93],{"label":91,"url":92},"Stanford Medicine Faculty Page","https:\u002F\u002Fmed.stanford.edu\u002Fprofiles\u002Fpeter-van-roessel",{"label":94,"url":95},"Rodriguez Lab Website","http:\u002F\u002Fmed.stanford.edu\u002Frodriguezlab\u002Fresearch.html",{"nct_id":4,"conditions":97,"biomarkers":102},[98,99,100,101],"Bodily distress disorder","Body dysmorphic disorder","Illness anxiety disorder","Obsessive Compulsive Disorder",[],{"nct_id":4,"found":104,"summary":105,"prompt_version":115},true,{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This is an interventional study with a planned enrollment of 16 participants. The phase of the study is not specified.","completed","Caloric Vestibular Stimulation for Obsessive-Compulsive Spectrum Disorders","This study is exploring if a treatment called Caloric Vestibular Stimulation can improve insight in people with obsessive-compulsive spectrum disorders. This involves using cold water to create a brief, mild sensation of spinning, similar to a test doctors already use. The study is looking for 16 participants aged 18 to 65 who have been diagnosed with Obsessive-Compulsive Disorder, Body Dysmorphic Disorder, or Illness Anxiety Disorder, and who meet specific criteria for their beliefs related to these conditions. The main goal is to see how much your insight changes after one hour, as measured by a specific assessment tool. The current recruitment status is unclear.","The primary endpoint is measured at 1 hour after the intervention.",104,"Not specified in the trial record.","Not stated in the trial record.",[22],"v2"]