NCT07455682

Auditory Processing in DOC Patients

Hierarchical Auditory Processing in Disorders of Consciousness: From Basic Deviance Detection to Semantic Integration

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 42 (estimated)
• Sponsor: BDH-Klinik Hessisch Oldendorf · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Disorder of Consciousness
• Unresponsive Wakefulness Syndrome
• Minimally Conscious State

Interventions

Type	Name	Description
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 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.

Timeline

• Start date: 2026-04-15
• Primary completion: 2027-11-30
• Completion: 2028-03-31
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: Germany