Auditory Processing in DOC Patients (NCT07455682) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Auditory Processing in DOC Patients
Germany42 participantsStarted 2026-04-15
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Highest Detectable Hierarchical Level of Auditory Processing
Timeframe: week 2-3 after admission to neurological rehabilitation