Disorder of ConsciousnessUnresponsive Wakefulness SyndromeMinimally Conscious State
Investigational drug(s) / intervention(s)
Coma Recovery Scale-Revised (CRS-R)Electroencephalography (EEG)
Coma Recovery Scale-Revised (CRS-R): The Coma Recovery Scale-Revised (CRS-R) is a standardized behavioral assessment instrument used to determine the level of consciousness in patients with severe brain injury. It comprises six subscales evaluating auditory, visual, motor, oromotor/verbal, communication, and arousal functions, with hierarchically structured items to identify the highest level of behavioral responsiveness.
Electroencephalography (EEG): Electroencephalography (EEG) is a non-invasive neurophysiological method used to record spontaneous and stimulus-related electrical brain activity via scalp electrodes. In this study, bedside EEG recordings are performed using structured auditory stimulation paradigms designed to elicit event-related potentials (ERPs). These include hierarchical paradigms assessing different levels of auditory processing, ranging from basic sensory discrimination (e.g., mismatch negativity, MMN) to higher-order cognitive processing (e.g., N400 responses). EEG-derived ERP markers are analyzed to determine the highest detectable level of auditory processing and to evaluate their association with clinical diagnosis and long-term functional outcome.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
Highest Detectable Hierarchical Level of Auditory Processing — 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).
Trial sites (1)
Facility
City
Region
Status
BDH-Klinik Hessisch Oldendorf
Hessisch Oldendorf
Lower Saxony
More BDH-Klinik Hessisch Oldendorf trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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