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临床试验/NCT06321146
NCT06321146尚未招募不适用

Evaluation of EEG Power Spectrum in Patients With Traumatic Coma

RenJi Hospital5 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
210
试验地点
5
主要终点
EEG power spectrum

研究概览

简要总结

Development of objective, reliable, and convenient assessment methods of disorders of consciousness is crucial. We aim to conduct multicenter prospective observational study and non-invasively collect EEG from patients with traumatic coma to analyze the sequential characteristics of EEG power spectrum, and explore their prognostic value for consciousness recovery.

详细描述

Trauma brain injury is a leading cause of chronic disorders of consciousness (DoC), posing significant socioeconomic burdens due to the extensive resources required for long-term medical care. DoC patients are clinically categorized into coma, Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS), with the latter further subdivided into MCS- and MCS+. The Coma Recovery Scale-Revised (CRS-R) remains a cornerstone for diagnosis and assessment of DoC, despite its susceptibility to fluctuations caused by various factors such as comorbidities and medication. Given these challenges, the development of objective, reliable, and convenient assessment methods of DoC is crucial. Electroencephalography (EEG) stands out for its accessibility and is recommended by guidelines. The mesocircuit model underscores the role of central thalamic neurons and their frontostriatal connections in maintaining consciousness. Based on this mechanism, EEG power spectra were categorized into 4 patterns, i.e. the ABCD model, which can be used to understand the varying levels of structural or functional deafferentation that occur in patients with DoC. Preliminary studies have shown the potential of corticothalamic EEG classification in correlating with CRS-R scores and neurological outcomes, suggesting its value in monitoring treatment effects and predicting prognosis. This multicenter prospective observational study aims to enroll patients with traumatic coma, analyze the sequential characteristics of corticothalamic EEG power spectrum, and explore their prognostic value for consciousness recovery.

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

入选标准

  • Coma over 28 days due to closed traumatic brain injury
  • Age above 18 years old
  • Consented by legal representative

排除标准

  • Unstable vital signs
  • History of mental disorder or neurodegenerative diseases
  • Uncontrolled epilepsy
  • Unable to record scalp EEG
  • Pregnancy

结局指标

主要结局

EEG power spectrum

时间窗: within 6 months after discharge

Sequential characteristics of spectral features for EEG in terms of frequency content (the 'ABCD' spectral categories)

次要结局

  • Coma Recovery Scale-Revised (CRS-R)(within 6 months after discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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