- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07477028
Non-Invasive Detection and Preservation of Neurocognitive Signals in the Peri-Death Period Using Brain-Computer Interface and Artificial Intelligence (NeuroCogPresv)
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
Status
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dr. Wallace Lynch, Ph.D.
- Phone Number: 6504895808
- Email: info@noahtech.life
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
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
Publications and helpful links
General Publications
- Zinn S, et al. Parametrization of the dying brain: A case report from ICU bed-side EEG monitoring. NeuroImage. 2025;305:120980.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NeuroCogConPres-NoahTech
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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