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

NCT07614581 · OMS-KAT · Adriaan Dirk van der Wart

Closed to entry
Status
Not accepting participants
Not applicable
Phase
5
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Intra-Sessional Autonomic Arc Trajectory Characterisation

    Measured over During KAT session (up to 6 hours)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

19 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Open Medicine StudioGangesBritish ColumbiaCanada

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07614581 on ClinicalTrials.gov →

Last updated in the registry 2026-05-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance