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 range

18 Years – 80 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is measuring something called the 'highest detectable hierarchical level of auditory processing' — can you explain in plain terms what that means for my loved one's condition, and whether understanding their level of auditory processing could actually change how their care is managed?
2Since this study isn't recruiting yet, how long might we realistically wait before it opens, and are there other options — like standard diagnostic assessments — we should pursue in the meantime rather than waiting?
3This trial involves patients with disorders of consciousness ranging from unresponsive wakefulness syndrome to minimally conscious state — given my loved one's specific diagnosis, would they likely be a candidate when the study does open, and what criteria might include or exclude them?
4Because this study is listed as Phase NA, it appears to be a diagnostic or observational study rather than a treatment trial — does that mean there's no experimental intervention involved, and if so, what are the actual risks or burdens of participation for someone in their current state?
5Could the results from this kind of auditory processing study help clarify whether my loved one has any level of awareness that current bedside assessments might be missing, and how would that information be used to guide decisions about their ongoing care?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Highest Detectable Hierarchical Level of Auditory Processing

Timeframe: week 2-3 after admission to neurological rehabilitation

Trial details

NCT IDNCT07455682

SponsorBDH-Klinik Hessisch Oldendorf

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-11-30

View on ClinicalTrials.gov More Disorder of Consciousness trials