Disorder of ConsciousnessAUD-DOCNCT07455682
Auditory Processing in DOC Patients
An observational study of Disorder of Consciousness and Unresponsive Wakefulness Syndrome, run by BDH-Klinik Hessisch Oldendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disorder of Consciousness, Unresponsive Wakefulness Syndrome, Minimally Conscious State
- What is being tested?
- Coma Recovery Scale-Revised (CRS-R) and Electroencephalography (EEG)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2026to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
BDH-Klinik Hessisch Oldendorf
Hessisch Oldendorf, Lower Saxony, 31840
Melanie Boltzmann, PhD, +49 5152781256, m.boltzmann@bdh-klinik-hessisch-oldendorf.de
Simone B. Jenner, +49 5152781215, s.jenner@bdh-klinik-hessisch-oldendorf.de
About this study
Official title: Hierarchical Auditory Processing in Disorders of Consciousness: From Basic Deviance Detection to Semantic Integration
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.
Read the 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.
- Being tested
- Coma Recovery Scale-Revised (CRS-R), Electroencephalography (EEG)
- Keywords
- Disorders of Consciousness, Electroencephalography (EEG), Event-related potential (ERP), Coma Recovery Scale-Revised (CRS-R), Acquired Brain Injury, Critically ill patients, Neurological rehabilitation
- Medical subject headings
- Consciousness Disorders, Persistent Vegetative State, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coma Recovery Scale-Revised (CRS-R)Behavioural
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.
Electroencephalography (EEG)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| UWS patients | Patients classified as unresponsive wakefulness syndrome (UWS) with the Coma Recovery Scale-Revised (CRS-R) Receives: Behavioral: Coma Recovery Scale-Revised (CRS-R); Behavioral: Electroencephalography (EEG) | |
| MCS patients | Patients classified as minimally conscious state (MCS) with the Coma Recovery Scale-Revised (CRS-R) Receives: Behavioral: Coma Recovery Scale-Revised (CRS-R); Behavioral: Electroencephalography (EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: week 2-3 after admission to neurological rehabilitation
Secondary outcomes (2)
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.
Measured: week 2-3 after admission to neurological rehabilitation
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.
Measured: 12 months after EEG measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BDH-Klinik Hessisch Oldendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455682
- Sponsor's protocol ID
- AUD-DOC
- Acronym
- AUD-DOC
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28543735Young 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.
PubMed 34347037Kotchoubey 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.
PubMed 16186040Kondziella 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 2020 Feb 23.
PubMed 32090418Engemann 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.
PubMed 30285102Cruse 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.
PubMed 22078855
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hierarchical Auditory Processing in Disorders of Consciousness: From Basic Deviance Detection to Semantic Integration
- ClinicalTrials.gov ID
- NCT07455682
- Acronym / sponsor ID
- AUD-DOC / AUD-DOC
- Keywords
- Disorders of Consciousness, Electroencephalography (EEG), Event-related potential (ERP), Coma Recovery Scale-Revised (CRS-R), Acquired Brain Injury, Critically ill patients, Neurological rehabilitation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- BDH-Klinik Hessisch OldendorfUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UWS patients | – | Behavioral: Coma Recovery Scale-Revised (CRS-R), Behavioral: Electroencephalography (EEG)Patients classified as unresponsive wakefulness syndrome (UWS) with the Coma Recovery Scale-Revised (CRS-R) |
| MCS patients | – | Behavioral: Coma Recovery Scale-Revised (CRS-R), Behavioral: Electroencephalography (EEG)Patients classified as minimally conscious state (MCS) with the Coma Recovery Scale-Revised (CRS-R) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | MCS patients, UWS patients |
| 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. | Behavioural | MCS patients, UWS patients |
Primary outcome
Highest Detectable Hierarchical Level of Auditory Processing
Time frame: week 2-3 after admission to neurological rehabilitation
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).
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background: PubMed 28543735Wannez 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.
- Background: PubMed 34347037Young 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.
- Background: PubMed 16186040Kotchoubey 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.
- Background: PubMed 32090418Kondziella 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 2020 Feb 23.
- Background: PubMed 30285102Engemann 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.
- Background: PubMed 22078855Cruse 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BDH-Klinik Hessisch Oldendorf
Hessisch Oldendorf, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder of Consciousness and Unresponsive Wakefulness Syndrome, run by BDH-Klinik Hessisch Oldendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highest Detectable Hierarchical Level of Auditory Processing (time frame: week 2-3 after admission to neurological rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07455682, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.