[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640217":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":10,"centralContacts":10,"locations":31,"responsibleParty":55,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":86,"whyStopped":10,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Dr. Adriaan van der Wart Medical Corp.","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adults with PTSD Undergoing Ketamine-Assisted Therapy",null,"Adults aged 19 years or older with a confirmed PTSD diagnosis (CAPS-5 score 23 or higher) who have independently arranged a ketamine-assisted therapy session with a licensed British Columbia physician or nurse practitioner. Participants wear a continuous wrist-worn biosensor (EmbracePlus) across preparation, intra-sessional, and integration monitoring phases. No intervention is administered by the researcher.",[13,14,15],"Device: Continuous wearable physiological monitoring (EmbracePlus, Empatica)","Drug: Ketamine-assisted therapy (independently arranged)","Other: Structured pre- and post-session interviews",[17,22,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"DEVICE","Continuous wearable physiological monitoring (EmbracePlus, Empatica)","Participants wear the EmbracePlus wrist-worn biosensor (Empatica Inc.) continuously throughout all study phases: a 3-7 day pre-session baseline period, the full duration of the KAT session, and 3-5 day monitoring windows at 1, 2, and 4 weeks post-session. The device records the interbeat interval stream, electrodermal activity (phasic and tonic components), skin temperature, and accelerometry. Both the HRV and EDA channels are required for valid arc-detection output. Data is streamed via Bluetooth to a secured local device and transferred to the study data layer within 24 hours of each monitoring session. Sessions with confirmed EDA channel loss exceeding 15% of the intra-sessional recording window are flagged and excluded from primary analysis.",[9],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"DRUG","Ketamine-assisted therapy (independently arranged)","Participants independently arrange their own ketamine-assisted therapy sessions with a licensed physician or nurse practitioner in British Columbia or Alberta prior to enrolment. Ketamine is administered solely by the licensed treating provider under existing clinical frameworks. The researcher does not administer, possess, or dispense ketamine in connection with this study and has no clinical role during the session. All clinical decisions and participant safety oversight remain entirely with the treating provider. This exposure is observed, not researcher-administered.",[9],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"Structured pre- and post-session interviews","A structured pre-session interview (30-45 minutes) is conducted within 48 hours before the KAT session, audio-recorded with participant consent, focusing on self-narrative and subjective state rather than trauma content. A structured post-session interview (30-45 minutes) is conducted within 4 hours of session end, mapping subjective experience to the session timeline and administering the Post-Session Subjective Integration Scale. Trauma-informed communication is used throughout. Interviews are conducted by the PI or Co-Investigator only; the right to pause or end the interview at any time is explicitly communicated to participants.",[9],[32],{"facility":33,"status":10,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Open Medicine Studio","Ganges","British Columbia","V8K 1R1","Canada","CA",{"type":40,"coordinates":41},"Point",[42,43],-123.50032,48.85342,{"lat":43,"lon":42},[46,51],{"name":47,"role":48,"phone":49,"phoneExt":10,"email":50},"Adriaan D van der Wart, MBChB","CONTACT","7789513194","doctor@medicinestudio.com",{"name":52,"role":48,"phone":53,"phoneExt":10,"email":54},"Natalie Moore","+1 4165756565","natalie@openmedicinestudio.com",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Adriaan Dirk van der Wart","Doctor","100640217","intra-sessional-autonomic-arc-detection-in-ketamine-assisted-therapy-for-ptsd-a-signal-characterisation-pilot-study-100640217",false,"NCT07614581","Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study","Intra-Sessional Autonomic Arc Detection Using Continuous HRV and EDA Monitoring in Adults Undergoing Ketamine-Assisted Therapy for PTSD: A Prospective Observational Signal Characterisation Pilot Study","OMS-KAT","Inclusion Criteria:\n\n1. Adults aged 19 to 65 years\n2. Currently enrolled in or referred for equine-assisted therapy at the study facility\n3. No prior relationship with the therapy horse assigned to their study sessions\n4. Able to wear a chest-strap heart rate monitor comfortably for 35 minutes\n5. Able to provide written informed consent in English\n6. Willing to have sessions video recorded for research purposes\n\nExclusion Criteria:\n\n1. Diagnosed cardiac arrhythmia of any type\n2. Implanted cardiac device including pacemaker or implantable cardioverter-defibrillator\n3. Current use of beta-blockers, calcium channel blockers, digoxin, or any other medication known to suppress or significantly alter heart rate variability\n4. Active psychosis or acute psychiatric crisis at time of enrolment\n5. Inability to provide written informed consent\n6. Pregnancy\n7. Prior participation in this study under a different horse pairing","ALL","19 Years","65 Years",{"count":71,"type":72},5,"ESTIMATED","OBSERVATIONAL","This study examines whether a continuous wearable biosensor and a proprietary signal detection algorithm (JungleCODE, Open Medicine Studio) can detect and characterise the autonomic nervous system arc - a trajectory from a state of high physiological arousal (aporia) to a state of regulated calm (ataraxia) - during ketamine-assisted therapy (KAT) sessions in adults with post-traumatic stress disorder (PTSD).\n\nParticipants independently arrange their own ketamine-assisted therapy sessions with a licensed British Columbia provider. The researcher does not administer ketamine or any other substance. The researcher's role is continuous physiological monitoring via a wrist-worn biosensor (EmbracePlus, Empatica) and a structured post-session interview only.\n\nThe primary purpose is to determine whether the JungleCODE arc-position detection algorithm can identify a consistent, characterisable autonomic trajectory within KAT sessions, and to assess the feasibility of this monitoring protocol. This is a pilot signal characterisation study (N=2-6); no therapeutic outcomes are assessed and no clinical claims are made.",[76],"Post-Traumatic Stress Disorder",[78,79,80,81,82,83,84,85],"Heart Rate Variability","Autonomic Nervous System","Neuroplasticity","Physiological Synchrony","Electrodermal Activity","Ketamine-Assisted Therapy","Signal Characterization","Wearable Biosensor","NOT_YET_RECRUITING","2026-05-28",{"date":89,"type":90},"2026-05-29","ACTUAL",{"date":92,"type":72},"2026-07-15",{"date":94,"type":72},"2026-09-30",{"name":57,"class":6},1]