This prospective observational pilot study (n=5) will assess whether continuous wearable physiological monitoring can characterise an intra-sessional autonomic arc during ketamine-assisted therapy in adults with post-traumatic stress disorder (PTSD). It will evaluate the feasibility of detecting a consistent autonomic trajectory, using continuous heart rate variability (HRV) and electrodermal activity (EDA) data collected during independently arranged ketamine sessions. Participants aged 19 years or older with confirmed PTSD will wear an EmbracePlus wrist-worn biosensor across a 3–7 day pre-session baseline period, the full ketamine-assisted therapy session, and 3–5 day follow-up monitoring windows at 1, 2 and 4 weeks after the session. The study also includes a structured pre-session interview within 48 hours before treatment and a structured post-session interview within 4 hours after session end, including administration of the Post-Session Subjective Integration Scale. Ketamine is administered solely by the participant’s licensed treating provider, and no drug is given by the researcher. The primary outcome is intra-sessional autonomic arc trajectory characterisation during the ketamine session, with sessions showing EDA channel loss exceeding 15% of the recording window excluded from primary analysis.
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 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.
Unmatched intervention treated as placebo placeholder: Continuous wearable physiological monitoring (EmbracePlus, Empatica)
Unmatched intervention treated as placebo placeholder: Structured pre- and post-session interviews