Not Yet RecruitingN/Aketamine

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

Sponsored by Adriaan Dirk van der Wart

NCT ID
NCT07614581
Target Enrollment
5 participants
Start Date
2026-07-15
Est. Completion
2026-09-30

About This Study

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.

Conditions Studied

Post-Traumatic Stress Disorder

Interventions

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

Eligibility

Age:19 Years - 65 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

1. Adults aged 19 to 65 years
2. Currently enrolled in or referred for equine-assisted therapy at the study facility
3. No prior relationship with the therapy horse assigned to their study sessions
4. Able to wear a chest-strap heart rate monitor comfortably for 35 minutes
5. Able to provide written informed consent in English
6. Willing to have sessions video recorded for research purposes

Exclusion Criteria:

1. Diagnosed cardiac arrhythmia of any type
2. Implanted cardiac device including pacemaker or implantable cardioverter-defibrillator
3. Current use of beta-blockers, calcium channel blockers, digoxin, or any other medication known to suppress or significantly alter heart rate variability
4. Active psychosis or acute psychiatric crisis at time of enrolment
5. Inability to provide written informed consent
6. Pregnancy
7. Prior participation in this study under a different horse pairing

Study Locations (1)

Open Medicine Studio
Ganges, British Columbia, Canada

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source