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).
Participants 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.
The 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.
Adults aged 19 to 65 years
Currently enrolled in or referred for equine-assisted therapy at the study facility
No prior relationship with the therapy horse assigned to their study sessions
Able to wear a chest-strap heart rate monitor comfortably for 35 minutes
Diagnosed cardiac arrhythmia of any type
Implanted cardiac device including pacemaker or implantable cardioverter-defibrillator
Current use of beta-blockers, calcium channel blockers, digoxin, or any other medication known to suppress or significantly alter heart rate variability
Active psychosis or acute psychiatric crisis at time of enrolment
Adults aged 19 years or older with a current or previous diagnosis of post-traumatic stress disorder confirmed by CAPS-5 clinical assessment (score 23 or higher), who have independently arranged a ketamine-assisted therapy session with a licensed physician or nurse practitioner in British Columbia, Canada. Participants are recruited through referrals from licensed ketamine-assisted therapy providers in British Columbia. This is a non-probability convenience sample consistent with the pilot and signal characterisation purpose of the study. No healthy volunteers are enrolled.
Cohort
Prospective
Continuous wearable physiological monitoring (EmbracePlus, Empatica)
DeviceParticipants 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.
Ketamine-assisted therapy (independently arranged)
DrugParticipants 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.
Structured pre- and post-session interviews
Other interventionA 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.
Intra-Sessional Autonomic Arc Trajectory Characterisation
Characterisation of the arc-position score trajectory generated by the JungleCODE algorithm applied to continuous HRV interbeat interval stream and electrodermal activity data from the EmbracePlus wearable. Arc position is expressed as the JungleCODE Arc-Position Score (range 0-100), where lower scores indicate greater sympathetic activation and maximal prior precision (aporia) and higher scores indicate greater parasympathetic dominance and regulatory restoration (ataraxia); higher scores represent a better autonomic outcome. Parameters include arc depth, inflection timing, transition event identification, and trajectory classification (progressive, regressive, plateau, or oscillating). The primary question is whether a coherent, characterisable autonomic arc can be detected within a ketamine-assisted therapy session.
Between-dyad variability in pulse event frequency
Intraclass correlation coefficient (ICC, two-way mixed model, absolute agreement) to quantify how much of the variance in the frequency of confirmed simultaneous HRV coherence spikes at rater-marked windows is attributable to the specific horse-human pairing versus session-level or individual-level factors. This outcome addresses whether certain horse-human pairs are systematically more likely to produce detectable pulse events - a finding that would have implications for both therapeutic practice and the design of subsequent studies.
Temporal Correspondence of Arc-Position Events to KAT Session Phases
Mapping of arc-position transition events onto recorded session phase timestamps (preparation, dosing onset, peak, integration onset) to characterise the temporal relationship between autonomic arc trajectory and the structured phases of the ketamine-assisted therapy session.
PCL-5 Score Change from Baseline
PTSD symptom severity as measured by the PTSD Checklist for DSM-5 (PCL-5 the Post-traumatic stress disorder of DSM-5 Checklist; range 0-80), where higher scores indicate greater PTSD symptom severity (worse outcome). Collected as an exploratory measure only. This pilot study is not powered to detect symptom-level change and no inferential analysis is pre-specified for this outcome.
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Adriaan Dirk van der Wart
Lead sponsor
Dr. Adriaan van der Wart Medical Corp.
Sponsor institution
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