Auditory Processing in DOC Patients

NCT07455682 | Not Yet Recruiting

• 1 other identifier: AUD-DOC
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Disorder of Consciousness; Unresponsive Wakefulness Syndrome; Minimally Conscious State

Keywords

Disorders of Consciousness; Electroencephalography (EEG); Event-related potential (ERP); Coma Recovery Scale-Revised (CRS-R); Acquired Brain Injury; Critically ill patients; Neurological rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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).

  week 2-3 after admission to neurological rehabilitation

Secondary Outcomes (2)

• Association Between Clinical Level of Consciousness and Neurophysiological Cognitive Processing

  week 2-3 after admission to neurological rehabilitation

• Prognostic Validity of ERP-Based Hierarchical Processing Level

  12 months after EEG measurement

Study Arms (2)

UWS patients

Patients classified as unresponsive wakefulness syndrome (UWS) with the Coma Recovery Scale-Revised (CRS-R)

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)

Behavioral: Coma Recovery Scale-Revised (CRS-R); Behavioral: Electroencephalography (EEG)

Interventions

Electroencephalography (EEG) BEHAVIORAL

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.

MCS patients; UWS patients

Coma Recovery Scale-Revised (CRS-R) BEHAVIORAL

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.

MCS patients; UWS patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BDH-Klinik Hessisch Oldendorf: lead

Study Sites (1)

BDH-Klinik Hessisch Oldendorf

Hessisch Oldendorf, Lower Saxony, 31840, Germany

Location

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 2020 Feb 23.

  PMID: 32090418 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Consciousness Disorders; Persistent Vegetative State; Brain Injuries

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Unconsciousness; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 6, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)