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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-65
SponsorAdriaan Dirk van der Wart

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Continuous wearable physiological monitoring (EmbracePlus, Empatica)
  • Ketamine-assisted therapy (independently arranged)
  • Structured pre- and post-session interviews

Treatment groups

5 Participants
are divided into 1 treatment group

Sponsors and collaborators

Adriaan Dirk van der Wart

Lead sponsor

Dr. Adriaan van der Wart Medical Corp.

Sponsor institution