NCT07477028

Brief Summary

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).

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
111mo left

Started Sep 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2030

5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2035

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

4.1 years

First QC Date

March 6, 2026

Last Update Submit

March 12, 2026

Conditions

Keywords

AIBCIBrain Computer InterfaceDeathGamma OscillationsCognitionConsciousnessPefi-deathBrain deathReservationMemoryLifeLife experienceTransferConvergence

Outcome Measures

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.

    0-120 minutes after clinical death

Secondary Outcomes (6)

  • Successful Capture and Preservation of Neurocognitive Signals

    Up to 24 hours after clinical death

  • Spectral Power of Neurocognitive Signals

    Up to 24 hours after clinical death

  • Functional Connectivity Patterns

    Up to 24 hours after clinical death

  • Cross-Frequency Coupling

    Up to 24 hours after clinical death

  • Temporal Dynamics of Neurocognitive Signals

    Up to 24 hours after clinical death

  • +1 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Zinn S, et al. Parametrization of the dying brain: A case report from ICU bed-side EEG monitoring. NeuroImage. 2025;305:120980.

    RESULT
  • Blundon EG, Gallagher RE, Ward LM. Electrophysiological evidence of preserved hearing at the end of life. Sci Rep. 2020 Jun 25;10(1):10336. doi: 10.1038/s41598-020-67234-9.

  • Xu G, Mihaylova T, Li D, Tian F, Farrehi PM, Parent JM, Mashour GA, Wang MM, Borjigin J. Surge of neurophysiological coupling and connectivity of gamma oscillations in the dying human brain. Proc Natl Acad Sci U S A. 2023 May 9;120(19):e2216268120. doi: 10.1073/pnas.2216268120. Epub 2023 May 1.

  • Vicente R, Rizzuto M, Sarica C, Yamamoto K, Sadr M, Khajuria T, Fatehi M, Moien-Afshari F, Haw CS, Llinas RR, Lozano AM, Neimat JS, Zemmar A. Enhanced Interplay of Neuronal Coherence and Coupling in the Dying Human Brain. Front Aging Neurosci. 2022 Feb 22;14:813531. doi: 10.3389/fnagi.2022.813531. eCollection 2022.

Related Links

MeSH Terms

Conditions

DeathBrain DeathNecrophobia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic Manifestations

Central Study Contacts

Dr. Wallace Lynch, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 17, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

September 30, 2035

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will become available beginning 12 months after the primary completion date and will remain available for a period of 5 years.
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.