Hierarchical Auditory Processing in Disorders of Consciousness: From Basic Deviance Detection to Semantic Integration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Highest Detectable Hierarchical Level of Auditory Processing
研究概览
简要总结
This prospective observational study investigates whether electroencephalography (EEG) can improve the differentiation between unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) in patients with severe acquired brain injury. The study further examines the association between EEG markers of auditory processing and long-term functional outcome at 12 months.
详细描述
Accurate classification of disorders of consciousness remains challenging in neurological early rehabilitation. Behavioral assessment is the clinical standard, yet misclassification persists, particularly in patients with severe motor impairment or fluctuating arousal. Neurophysiological measures may provide complementary information beyond observable behavior.
This study applies event-related potential (ERP) paradigms during bedside EEG recording to assess hierarchical levels of auditory processing in patients with disorders of consciousness in the subacute phase after brain injury. The paradigms are designed to detect neural responses reflecting basic auditory discrimination as well as higher-order cognitive processing.
The primary objective is to determine the highest neurophysiologically detectable level of auditory processing and to examine whether it differs between clinically defined consciousness groups. Secondary objectives include evaluating the relationship between EEG-derived markers and standardized behavioral assessments, as well as assessing the prognostic value of EEG findings for functional outcome one year after admission.
The study aims to clarify the diagnostic and prognostic relevance of EEG-based measures in routine neurorehabilitation settings.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of a disorder of consciousness (Unresponsive Wakefulness Syndrome [UWS] or Minimally Conscious State [MCS]), classified using the Coma Recovery Scale-Revised (CRS-R) based on three assessments conducted on at least two separate days
- •Age between 18 and 80 years
- •Written informed consent provided by the patient's legal representative
- •Preserved brainstem auditory evoked potentials (BAEPs) on at least one side
排除标准
- •Ongoing sedation at the time of EEG assessment
- •Current treatment with medications known to significantly affect cortical functional state, including barbiturates, neuroleptics (antipsychotics), antiepileptic drugs, benzodiazepines, or comparable agents
- •Colonization with multidrug-resistant organisms requiring isolation precautions (e.g., 4MRGN)
- •Pregnancy
- •Impaired language comprehension (e.g., insufficient German language proficiency or aphasia)
- •Temporal bone fractures or severe infratentorial brain injury associated with unilateral or bilateral absence of auditory evoked potentials (AEPs)
- •Bilateral hearing impairment or deafness, or presence of a cochlear implant
- •Scalp wounds or conditions preventing placement of an EEG electrode cap
研究组 & 干预措施
UWS patients
Patients classified as unresponsive wakefulness syndrome (UWS) with the Coma Recovery Scale-Revised (CRS-R)
干预措施: Coma Recovery Scale-Revised (CRS-R) (Behavioral)
UWS patients
Patients classified as unresponsive wakefulness syndrome (UWS) with the Coma Recovery Scale-Revised (CRS-R)
干预措施: Electroencephalography (EEG) (Behavioral)
MCS patients
Patients classified as minimally conscious state (MCS) with the Coma Recovery Scale-Revised (CRS-R)
干预措施: Coma Recovery Scale-Revised (CRS-R) (Behavioral)
MCS patients
Patients classified as minimally conscious state (MCS) with the Coma Recovery Scale-Revised (CRS-R)
干预措施: Electroencephalography (EEG) (Behavioral)
结局指标
主要结局
Highest Detectable Hierarchical Level of Auditory Processing
时间窗: week 2-3 after admission to neurological rehabilitation
The primary endpoint is the highest neurophysiologically detectable hierarchical level of auditory processing, operationalized by the presence of significant auditory event-related potential (ERP) effects. For each ERP paradigm, analyses are conducted at the individual patient level to determine whether a statistically significant ERP effect is present within predefined time windows and electrode regions. The highest hierarchy level showing a significant effect defines the individual outcome (ordinal scale: levels 1-4).
次要结局
- Association Between Clinical Level of Consciousness and Neurophysiological Cognitive Processing(week 2-3 after admission to neurological rehabilitation)
- Prognostic Validity of ERP-Based Hierarchical Processing Level(12 months after EEG measurement)