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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Detection of Neurocognitive Signals After Clinical Death Prior to Brain Death
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Detection of Neurocognitive Signals After Clinical Death Prior to Brain Death
时间窗: 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.
次要结局
- 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)
- Informational Content of Neurocognitive Signals(Up to 24 hours after clinical death)