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

March 12, 2026 updated by: Noah Tech, Corp.

Feasibility of Non-Invasive Detection and Preservation of Neurocognitive Signals in the Peri-Death Period Using Brain-Computer Interface and Artificial Intelligence: A Prospective Observational Study (NeuroCogPresv)

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).

Study Overview

Detailed Description

This prospective observational feasibility study will use non-invasive high-density EEG combined with a wireless brain-computer interface (BCI) and artificial intelligence analytics to detect, characterize, and archive neurocognitive signals in adult patients during the peri-death period. The study includes individuals with terminal illness or severe acute trauma who have a do-not-resuscitate (DNR/DNI) order. Building on recent human findings of gamma oscillation surges and cross-frequency coupling (Vicente et al., 2022; Xu et al., 2023), the study aims to quantify these signals, test AI-driven real-time classification, and explore technical feasibility for future signal preservation and continuity research. No therapeutic intervention is performed. All monitoring is conducted with surrogate consent under strict ethical oversight.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  1. Adults ≥18 years with terminal illness or severe acute trauma
  2. Do-not-resuscitate (DNR/DNI) order in place
  3. Surrogate decision-maker available and willing to provide informed consent
  4. Expected survival ≤7 days (physician estimate)

Exclusion Criteria:

  1. Brain death already declared > 24 hours prior to enrollment
  2. Contraindication to EEG/BCI headset placement (e.g., severe scalp injury)
  3. Patient lacks a legally authorized representative

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Peri-Death Cohort
Adults (≥18 years) with terminal illness or severe acute trauma who have a do-not-resuscitate (DNR/DNI) order and for whom surrogate informed consent has been obtained. Participants undergo continuous non-invasive high-density EEG monitoring using a wireless brain-computer interface (BCI) headset. Monitoring begins prior to expected clinical death and continues for up to 6 hours after cardiac arrest. This single prospective cohort is followed to characterize neurocognitive signals during the transition from clinical death through brain death to cellular death. No study intervention is administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of Neurocognitive Signals After Clinical Death Prior to Brain Death
Time Frame: 0-120 minutes after clinical 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.
0-120 minutes after clinical death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Capture and Preservation of Neurocognitive Signals
Time Frame: Up to 24 hours after clinical death
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.
Up to 24 hours after clinical death
Spectral Power of Neurocognitive Signals
Time Frame: Up to 24 hours after clinical death
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).
Up to 24 hours after clinical death
Functional Connectivity Patterns
Time Frame: Up to 24 hours after clinical death
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).
Up to 24 hours after clinical death
Cross-Frequency Coupling
Time Frame: Up to 24 hours after clinical death
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).
Up to 24 hours after clinical death
Temporal Dynamics of Neurocognitive Signals
Time Frame: Up to 24 hours after clinical death
Quantitative analysis of the temporal dynamics of neurocognitive signals, including signal duration and onset latency, measured in seconds (s) from the time of clinical death.
Up to 24 hours after clinical death
Informational Content of Neurocognitive Signals
Time Frame: Up to 24 hours after clinical death
Qualitative and quantitative analysis of the potential informational content of captured neurocognitive signals, measured using permutation entropy, reported as a unitless value on a scale from 0 (completely regular/predictable) to 1 (completely random).
Up to 24 hours after clinical death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

September 30, 2035

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified raw EEG data, AI-processed neurocognitive signal files, and limited demographic information will be made available to qualified researchers upon reasonable request. Data will be shared via a secure, public repository (e.g., Zenodo or NIH-compliant platform) to support future research on consciousness and neurocognitive activity in the peri-death period.

IPD Sharing Time Frame

Data will become available beginning 12 months after the primary completion date and will remain available for a period of 5 years.

IPD Sharing Access Criteria

Qualified scientific researchers with an IRB-approved research proposal and relevant scientific background. All requests will be reviewed and approved by the study sponsor (NoahTech Corp.) and the responsible IRB. Access will be granted through a secure data-sharing platform after execution of a data use agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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