Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Intra-Sessional Autonomic Arc Trajectory Characterisation — During KAT session (up to 6 hours)
  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.

Trial sites (1)

Other trials for the same condition