Auditory Processing in DOC Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coma Recovery Scale-Revised (CRS-R), Electroencephalography (EEG).
- Who it may be relevant to
- Registry conditions: Disorder of Consciousness, Unresponsive Wakefulness Syndrome, Minimally Conscious State. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Hierarchical Auditory Processing in Disorders of Consciousness: From Basic Deviance Detection to Semantic Integration
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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. - Behavioral 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
Primary outcome measures
- Highest Detectable Hierarchical Level of Auditory Processing [Time frame: week 2-3 after admission to neurological rehabilitation]
Secondary outcome measures (2)
- Association Between Clinical Level of Consciousness and Neurophysiological Cognitive Processing [Time frame: week 2-3 after admission to neurological rehabilitation]
- Prognostic Validity of ERP-Based Hierarchical Processing Level [Time frame: 12 months after EEG measurement]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- BDH-Klinik Hessisch Oldendorf — Hessisch Oldendorf
Publications
- Wannez S, Heine L, Thonnard M, Gosseries O, Laureys S; Coma Science Group collaborators. The repetition of behavioral assessments in diagnosis of disorders of consciousness. Ann Neurol. 2017 Jun;81(6):883-889. doi: 10.1002/ana.24962. PMID 28543735
- Young MJ, Bodien YG, Giacino JT, Fins JJ, Truog RD, Hochberg LR, Edlow BL. The neuroethics of disorders of consciousness: a brief history of evolving ideas. Brain. 2021 Dec 16;144(11):3291-3310. doi: 10.1093/brain/awab290. PMID 34347037
- Kotchoubey B. Event-related potential measures of consciousness: two equations with three unknowns. Prog Brain Res. 2005;150:427-44. doi: 10.1016/S0079-6123(05)50030-X. PMID 16186040
- Kondziella D, Bender A, Diserens K, van Erp W, Estraneo A, Formisano R, Laureys S, Naccache L, Ozturk S, Rohaut B, Sitt JD, Stender J, Tiainen M, Rossetti AO, Gosseries O, Chatelle C; EAN Panel on Coma, Disorders of Consciousness. European Academy of Neurology guideline on the diagnosis of coma and other disorders of consciousness. Eur J Neurol. 2020 May;27(5):741-756. doi: 10.1111/ene.14151. Epub PMID 32090418
- Engemann DA, Raimondo F, King JR, Rohaut B, Louppe G, Faugeras F, Annen J, Cassol H, Gosseries O, Fernandez-Slezak D, Laureys S, Naccache L, Dehaene S, Sitt JD. Robust EEG-based cross-site and cross-protocol classification of states of consciousness. Brain. 2018 Nov 1;141(11):3179-3192. doi: 10.1093/brain/awy251. PMID 30285102
- Cruse D, Chennu S, Chatelle C, Bekinschtein TA, Fernandez-Espejo D, Pickard JD, Laureys S, Owen AM. Bedside detection of awareness in the vegetative state: a cohort study. Lancet. 2011 Dec 17;378(9809):2088-94. doi: 10.1016/S0140-6736(11)61224-5. Epub 2011 Nov 9. PMID 22078855
Identifiers
NCT: NCT07455682 · AUD-DOC