Non-Invasive Detection and Preservation of Neurocognitive Signals in the Peri-Death Period Using Brain-Computer Interface and Artificial Intelligence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Terminal Illness, End-of-Life Care, Death, Brain Death. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
Primary outcome measures
- Detection of Neurocognitive Signals After Clinical Death Prior to Brain Death [Time frame: 0-120 minutes after clinical death]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 39701335
- 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. PMID 32587364
- 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. PMID 37126719
- 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. PMID 35273490
Identifiers
NCT: NCT07477028 · NeuroCogConPres-NoahTech