Non-Invasive Detection and Preservation of Neurocognitive Signals in the Peri-Death Period Using Brain-Computer Interface and Artificial Intelligence

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNoah Tech, Corp.

About this trial

Background: Recent electroencephalography (EEG) data indicate that the transition from clinical death to cellular death is marked by highly organized neurophysiological events, including significant surges in gamma-band power, cross-frequency coupling, and distinct spreading depolarization waves. This prospective, observational feasibility study utilizes rapid-deployment, high-density, noninvasive BCI hardware paired with proprietary AI analytics to detect, classify, and securely archive these terminal neurocognitive signals.

Objectives: (1) Quantify transient gamma-band activity and cross-frequency connectivity post-clinical death; (2) Validate the efficacy of machine learning models for real-time signal classification in high-noise clinical environments; (3) Establish a highly secure, encrypted bio-informational archive of peri-life EEG data.

Design: Prospective, open-label, multicenter, observational cohort (n\>20).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults ≥18 years with terminal illness or severe acute trauma

Do-not-resuscitate (DNR/DNI) order in place

Surrogate decision-maker available and willing to provide informed consent

Expected survival ≤7 days (physician estimate)

Disqualifiers

Brain death already declared > 24 hours prior to enrollment

Contraindication to EEG/BCI headset placement (e.g., severe scalp injury)

Patient lacks a legally authorized representative

Trial population

Adults (≥18 years) with terminal illness or severe acute trauma who have a do-not-resuscitate (DNR/DNI) order and for whom a legally authorized surrogate has provided informed consent. Participants are recruited from hospice, palliative care units, and intensive care units at three U.S. academic medical centers. The study focuses on individuals with physician-estimated survival of 7 days or less. All participants receive continuous non-invasive EEG/BCI monitoring during the peri-death period.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

20 Participants
are grouped into 1 trial group
Group A: Peri-Death Cohort

Trial outcomes

Primary outcomes

1

Detection of Neurocognitive Signals After Clinical Death Prior to Brain Death

Presence or absence of organized neurocognitive signals and measurable brain activity, as recorded by non-invasive high-density electroencephalography (EEG), in the human brain during the period immediately following clinical death (cessation of circulation) but prior to declaration of brain death. The primary outcome will be reported as the proportion of participants with detectable organized neural activity (yes/no) meeting predefined signal thresholds.

Time frame
0-120 minutes after clinical death

Secondary outcomes

1

Successful Capture and Preservation of Neurocognitive Signals

Proportion of participants for whom real-time neurocognitive signals were successfully captured, recorded in high quality, and securely preserved for long-term storage using non-invasive high-density EEG and wireless brain-computer interface (BCI) technology. Reported as the number and percentage of participants with complete, artifact-free recordings suitable for analysis.

Time frame
Up to 24 hours after clinical death
2

Spectral Power of Neurocognitive Signals

Quantitative analysis of spectral power of captured neurocognitive signals, measured in microvolts squared per hertz (µV²/Hz), across standard EEG frequency bands (delta, theta, alpha, beta, gamma).

Time frame
Up to 24 hours after clinical death
3

Functional Connectivity Patterns

Quantitative analysis of functional connectivity patterns among brain regions, measured using coherence and phase-locking value (PLV) indices, reported on a scale from 0 (no connectivity) to 1 (perfect connectivity).

Time frame
Up to 24 hours after clinical death
4

Cross-Frequency Coupling

Quantitative analysis of cross-frequency coupling between EEG frequency bands, measured using the modulation index (MI), reported as a unitless value ranging from 0 (no coupling) to 1 (maximum coupling).

Time frame
Up to 24 hours after clinical death

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Noah Tech, Corp.

Lead sponsor

Columbia University

Collaborator

Massachusetts Institute of Technology

Collaborator

Stanford University

Collaborator

City of Hope Medical Center

Collaborator

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