Auditory Processing in DOC Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorBDH-Klinik Hessisch Oldendorf
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population consists of adult patients (18-80 years) with severe acquired brain injury in the subacute phase who are diagnosed with a disorder of consciousness (Unresponsive Wakefulness Syndrome or Minimally Conscious State) in a neurological rehabilitation setting.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Coma Recovery Scale-Revised (CRS-R)
BehavioralThe 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)
BehavioralElectroencephalography (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.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: UWS patients2 interventions
Group B: MCS patients2 interventions
Trial outcomes
Primary outcomes
1
Highest Detectable Hierarchical Level of Auditory Processing
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).
Time frame
week 2-3 after admission to neurological rehabilitationSecondary outcomes
1
Association Between Clinical Level of Consciousness and Neurophysiological Cognitive Processing
Relationship between clinically determined consciousness status (e.g., UWS vs. MCS) and the highest achieved hierarchical level of auditory processing as measured by ERP responses.
Time frame
week 2-3 after admission to neurological rehabilitation2
Prognostic Validity of ERP-Based Hierarchical Processing Level
Predictive value of the highest achieved hierarchical level of auditory processing for functional outcome at 12 months after admission. Functional status will be assessed using a standardized outcome measure.
Time frame
12 months after EEG measurementSponsors and contacts
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Source ClinicalTrials.gov
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