Terminal IllnessNeuroCogPresvNCT07477028
Non-Invasive Detection and Preservation of Neurocognitive Signals in the Peri-Death Period Using Brain-Computer Interface and Artificial Intelligence
An observational study of Terminal Illness and End-of-Life Care, run by Noah Tech, Corp..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Terminal Illness, End-of-Life Care, Death
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Sep 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
Read the 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.
- Conditions
- Terminal Illness, End-of-Life Care, Death, Brain Death, Death Anxiety, Consciousness
- Keywords
- AI, BCI, Brain Computer Interface, Death, Gamma Oscillations, Cognition, Consciousness, Pefi-death, Brain death, Reservation, Memory, Life, Life experience, Transfer, Convergence
- Medical subject headings
- Death, Brain Death, Necrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-120 minutes after clinical death
Secondary outcomes (6)
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.
Measured: Up to 24 hours after clinical death
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).
Measured: Up to 24 hours after clinical death
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).
Measured: Up to 24 hours after clinical death
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).
Measured: Up to 24 hours after clinical death
Temporal Dynamics of Neurocognitive Signals
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.
Measured: Up to 24 hours after clinical death
Informational Content of Neurocognitive Signals
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).
Measured: Up to 24 hours after clinical death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Terminal IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noah Tech, Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Columbia University, Massachusetts Institute of Technology, Stanford University, City of Hope Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477028
- Sponsor's protocol ID
- NeuroCogConPres-NoahTech
- Acronym
- NeuroCogPresv
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Zinn S, Dragovic SZ, Kloka JA, Willems LM, Harder S, Kratzer S, Zacharowski KD, Schneider G, Garcia PS, Kreuzer M. Parametrization of the dying brain: A case report from ICU bed-side EEG monitoring. Neuroimage. 2025 Jan;305:120980. doi: 10.1016/j.neuroimage.2024.120980. Epub 2024 Dec 17.
PubMed 39701335Blundon 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.
PubMed 32587364Xu 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.
PubMed 37126719Vicente 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.
PubMed 35273490
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07477028
- Acronym / sponsor ID
- NeuroCogPresv / NeuroCogConPres-NoahTech
- Conditions
- Terminal Illness, End-of-Life Care, Death, Brain Death, Death Anxiety, Consciousness
- Keywords
- AI, BCI, Brain Computer Interface, Death, Gamma Oscillations, Cognition, Consciousness, Pefi-death
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Noah Tech, Corp.Industry (pharma, biotech, devices)
- Collaborators
- Columbia University, Massachusetts Institute of Technology, Stanford University, City of Hope Medical Center
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2035 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Successful Capture and Preservation of Neurocognitive Signals
Time frame: Up to 24 hours after clinical death
Spectral Power of Neurocognitive Signals
Time frame: Up to 24 hours after clinical death
Functional Connectivity Patterns
Time frame: Up to 24 hours after clinical death
Cross-Frequency Coupling
Time frame: Up to 24 hours after clinical death
Temporal Dynamics of Neurocognitive Signals
Time frame: Up to 24 hours after clinical death
Informational Content of Neurocognitive Signals
Time frame: Up to 24 hours after clinical death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Results publication: PubMed 39701335Zinn S, Dragovic SZ, Kloka JA, Willems LM, Harder S, Kratzer S, Zacharowski KD, Schneider G, Garcia PS, Kreuzer M. Parametrization of the dying brain: A case report from ICU bed-side EEG monitoring. Neuroimage. 2025 Jan;305:120980. doi: 10.1016/j.neuroimage.2024.120980. Epub 2024 Dec 17.
- Results publication: PubMed 32587364Blundon 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.
- Results publication: PubMed 37126719Xu 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.
- Results publication: PubMed 35273490Vicente 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.
- NoahTech Corp. Official Sponsor WebsiteLink provided by the sponsor.
- ClinicalTrials.gov Study RecordLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Terminal Illness and End-of-Life Care, run by Noah Tech, Corp..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Wallace Lynch, Ph.D. (6504895808, info@noahtech.life), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Neurocognitive Signals After Clinical Death Prior to Brain Death (time frame: 0-120 minutes after clinical death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07477028, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.