Disorders of Consciousness Due to Severe Brain InjuryAssessConscNCT07456020
Assessment of Consciousness With CRS-R and SECONDs
An observational study of Disorders of Consciousness Due to Severe Brain Injury and Minimally Conscious State, run by BDH-Klinik Hessisch Oldendorf at 1 site in Germany.
Trial summary
Accurately determining the level of consciousness in patients with severe brain injury is essential for treatment planning, prognosis, and ethical decision-making. Clinically, levels of consciousness are differentiated into coma, Unresponsive Wakefulness Syndrome (UWS), and Minimally Conscious State (MCS) based on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorders of Consciousness Due to Severe Brain Injury, Minimally Conscious State, Unresponsive Wakefulness Syndrome
- What is being tested?
- Simplified Evaluation of CONsciousness Disorders (SECONDs) and Coma Recovery Scale-Revised (CRS-R)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients with severe acquired brain injury admitted to a neurological early rehabilitation program. Eligible participants present with a disorder of consciousness in the subacute phase (within 90 days after the index event) and require intensive or monitored medical care. Underlying etiologies include anoxic, traumatic, or vascular brain injury. Patients are characterized by severe functional impairment, as reflected by a low Early Rehabilitation Barthel Index score at admission.
Who may be able to join
- Admission to an intensive care unit (ICU) or intermediate/high-dependency care unit
- Underlying etiology of brain injury: anoxic, traumatic, or vascular
- Time since index event < 90 days
- Early Rehabilitation Barthel Index (ERBI) score < 30 points
Who cannot join
- History of prior brain injury
- Pre-existing major psychiatric disorder
- Impaired language comprehension (e.g., insufficient German language proficiency or aphasia)
- Ongoing sedation at the time of assessment
- Interruption of rehabilitation treatment (transfer to an acute care hospital) for more than 14 days
- isolation precautions due to multidrug-resistant organisms
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, 1 recruiting
- Recruiting
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: Assessment of Consciousness After Severe Brain Injury: Comparison of CRS-R and SECONDs
Accurately determining the level of consciousness in patients with severe brain injury is essential for treatment planning, prognosis, and ethical decision-making. Clinically, levels of consciousness are differentiated into coma, Unresponsive Wakefulness Syndrome (UWS), and Minimally Conscious State (MCS) based on behavioral signs. Although behavioral assessment is considered the clinical gold standard, it is prone to misclassification. Research has shown that a substantial proportion of patients initially diagnosed with UWS may actually show signs of minimal consciousness, which is associated with better cognitive abilities and a more favorable prognosis.
The Coma Recovery Scale-Revised (CRS-R) is internationally recommended for diagnosing disorders of consciousness, but it is time-consuming and not free from diagnostic error. Repeated assessments can significantly improve diagnostic accuracy. To enhance feasibility in routine clinical practice, a shorter and more time-efficient assessment tool, the Simplified Evaluation of CONsciousness Disorders (SECONDs), was developed. This scale focuses on the behavioral signs most strongly associated with MCS and uses optimized testing procedures while maintaining high diagnostic accuracy.
The aim of this study is to further evaluate diagnostic approaches for assessing consciousness in patients with severe brain injury and to improve the reliability and clinical applicability of these assessments.
Read the detailed description
This prospective observational study is designed to evaluate the clinical utility and diagnostic performance of the Simplified Evaluation of CONsciousness Disorders (SECONDs) in a neurological rehabilitation setting. The study aims to assess whether the implementation of SECONDs improves diagnostic accuracy in patients with disorders of consciousness during the subacute phase after severe acquired brain injury.
Participants will undergo structured behavioral assessment using SECONDs as part of the study protocol. Diagnostic classifications derived from SECONDs will be analyzed with regard to their internal consistency and clinical plausibility within the rehabilitation context.
To examine prognostic validity, functional outcome will be assessed 12 months after the initial evaluation. Follow-up data will be collected through structured telephone interviews with relatives or legal representatives. Functional status will be systematically documented in order to determine the predictive value of SECONDs classifications for long-term clinically relevant outcomes.
The study seeks to contribute to optimizing diagnostic procedures in disorders of consciousness and to strengthen the evidence base for time-efficient behavioral assessment tools in routine neurorehabilitation practice.
- Conditions
- Disorders of Consciousness Due to Severe Brain Injury, Minimally Conscious State, Unresponsive Wakefulness Syndrome
- Being tested
- Simplified Evaluation of CONsciousness Disorders (SECONDs), Coma Recovery Scale-Revised (CRS-R)
- Keywords
- Disorders of consciousness, Coma Recovery Scale-Revised, SECONDs, Acquired Brain Injury, Neurological rehabilitation, Critical ill patients
- Medical subject headings
- Persistent Vegetative State, Consciousness Disorders, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplified Evaluation of CONsciousness Disorders (SECONDs)Behavioural
The Simplified Evaluation of CONsciousness Disorders (SECONDs) is a structured behavioral assessment tool designed for the rapid evaluation of patients with disorders of consciousness.
Coma Recovery Scale-Revised (CRS-R)Behavioural
The Coma Recovery Scale-Revised (CRS-R) is a standardized behavioral assessment tool used to evaluate the level of consciousness in patients with severe brain injury. It consists of six subscales assessing auditory, visual, motor, oromotor/verbal, communication, and arousal functions.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Disorders of Consciousness | Adult patients with severe acquired brain injury diagnosed with a disorder of consciousness (e.g., unresponsive wakefulness syndrome or minimally conscious state) undergoing structured behavioral assessment in a neurological rehabilitation setting. Receives: Behavioral: Simplified Evaluation of CONsciousness Disorders (SECONDs); Behavioral: Coma Recovery Scale-Revised (CRS-R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Between the "Simplified Evaluation of CONsciousness Disorders" (SECONDs; Range: 0-8) and the "Coma Recovery Scale-Revised" (CRS-R; Range: 0-23)
Categorical agreement in clinical classification of level of consciousness (Unresponsive Wakefulness Syndrome [UWS], Minimally Conscious State [MCS], Emerged from Minimally Conscious State [eMCS], No Disorder of Consciousness [non-DoC]) between the Simplified Evaluation of CONsciousness Disorders (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).
Measured: 6-8 days after admission to neurological rehabilitation
Secondary outcomes (3)
Diagnostic Stability in Patients Initially Classified as UWS
Rate of diagnostic reclassification following repeated behavioral assessment on two consecutive days in patients initially diagnosed with Unresponsive Wakefulness Syndrome (UWS). Misdiagnosis rate is defined as the proportion of patients whose level of consciousness is reclassified into a different diagnostic category (e.g., from UWS to Minimally Conscious State [MCS]) upon repeat measurement.
Measured: 6-8 days after admission to neurological rehabilitation
Prognostic Validity of the "Simplified Evaluation of CONsciousness Disorders" (SECONDs; Range: 0-8) for Long-Term Functional Outcome
Predictive value of baseline classification using the Simplified Evaluation of CONsciousness Disorders (SECONDs; ; Range: 0-8) for functional outcome at 12 months after admission, as measured by the Glasgow Outcome Scale-Extended (GOSE; Range: 1-8).
Measured: 12 months after admission.
Feasibility of the Simplified Evaluation of CONsciousness Disorders (SECONDs)
Assessment of clinical feasibility of SECONDs in a neurological rehabilitation setting, including test completion rate, administration time per assessment, and occurrence of premature test termination or technical/practical difficulties.
Measured: 6-8 days after admission to neurological rehabilitation
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 start1 Feb 2026
- 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 (2)Papers the sponsor has linked to this study.
- Other trials for Disorders of Consciousness Due to Severe Brain InjuryStudies 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BDH-Klinik Hessisch Oldendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie Boltzmann, PhD, Principal investigator, BDH-Klinik Hessisch Oldendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456020
- Sponsor's protocol ID
- 12079-BO-S-2025
- Acronym
- AssessConsc
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 11 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 28543735Schnakers C, Vanhaudenhuyse A, Giacino J, Ventura M, Boly M, Majerus S, Moonen G, Laureys S. Diagnostic accuracy of the vegetative and minimally conscious state: clinical consensus versus standardized neurobehavioral assessment. BMC Neurol. 2009 Jul 21;9:35. doi: 10.1186/1471-2377-9-35.
PubMed 19622138
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Consciousness After Severe Brain Injury: Comparison of CRS-R and SECONDs
- ClinicalTrials.gov ID
- NCT07456020
- Acronym / sponsor ID
- AssessConsc / 12079-BO-S-2025
- Conditions
- Disorders of Consciousness Due to Severe Brain Injury, Minimally Conscious State, Unresponsive Wakefulness Syndrome
- Keywords
- Disorders of consciousness, Coma Recovery Scale-Revised, SECONDs, Acquired Brain Injury, Neurological rehabilitation, Critical ill patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- BDH-Klinik Hessisch OldendorfUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- 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.
Accurately determining the level of consciousness in patients with severe brain injury is essential for treatment planning, prognosis, and ethical decision-making. Clinically, levels of consciousness are differentiated into coma, Unresponsive Wakefulness Syndrome (UWS), and Minimally Conscious State (MCS) based on behavioral signs. Although behavioral assessment is considered the clinical gold standard, it is prone to misclassification. Research has shown that a substantial proportion of patients initially diagnosed with UWS may actually show signs of minimal consciousness, which is associated with better cognitive abilities and a more favorable prognosis.
The Coma Recovery Scale-Revised (CRS-R) is internationally recommended for diagnosing disorders of consciousness, but it is time-consuming and not free from diagnostic error. Repeated assessments can significantly improve diagnostic accuracy. To enhance feasibility in routine clinical practice, a shorter and more time-efficient assessment tool, the Simplified Evaluation of CONsciousness Disorders (SECONDs), was developed. This scale focuses on the behavioral signs most strongly associated with MCS and uses optimized testing procedures while maintaining high diagnostic accuracy.
The aim of this study is to further evaluate diagnostic approaches for assessing consciousness in patients with severe brain injury and to improve the reliability and clinical applicability of these assessments.
Detailed description
This prospective observational study is designed to evaluate the clinical utility and diagnostic performance of the Simplified Evaluation of CONsciousness Disorders (SECONDs) in a neurological rehabilitation setting. The study aims to assess whether the implementation of SECONDs improves diagnostic accuracy in patients with disorders of consciousness during the subacute phase after severe acquired brain injury.
Participants will undergo structured behavioral assessment using SECONDs as part of the study protocol. Diagnostic classifications derived from SECONDs will be analyzed with regard to their internal consistency and clinical plausibility within the rehabilitation context.
To examine prognostic validity, functional outcome will be assessed 12 months after the initial evaluation. Follow-up data will be collected through structured telephone interviews with relatives or legal representatives. Functional status will be systematically documented in order to determine the predictive value of SECONDs classifications for long-term clinically relevant outcomes.
The study seeks to contribute to optimizing diagnostic procedures in disorders of consciousness and to strengthen the evidence base for time-efficient behavioral assessment tools in routine neurorehabilitation practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Disorders of Consciousness | – | Behavioral: Simplified Evaluation of CONsciousness Disorders (SECONDs), Behavioral: Coma Recovery Scale-Revised (CRS-R)Adult patients with severe acquired brain injury diagnosed with a disorder of consciousness (e.g., unresponsive wakefulness syndrome or minimally conscious state) undergoing structured behavioral assessment in a neurological rehabilitation setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients with severe acquired brain injury admitted to a neurological early rehabilitation program. Eligible participants present with a disorder of consciousness in the subacute phase (within 90 days after the index event) and require intensive or monitored medical care. Underlying etiologies include anoxic, traumatic, or vascular brain injury. Patients are characterized by severe functional impairment, as reflected by a low Early Rehabilitation Barthel Index score at admission.
Key inclusion criteria (4 listed)
- Admission to an intensive care unit (ICU) or intermediate/high-dependency care unit
- Underlying etiology of brain injury: anoxic, traumatic, or vascular
- Time since index event < 90 days
- Early Rehabilitation Barthel Index (ERBI) score < 30 points
Key exclusion criteria (6 listed)
- History of prior brain injury
- Pre-existing major psychiatric disorder
- Impaired language comprehension (e.g., insufficient German language proficiency or aphasia)
- Ongoing sedation at the time of assessment
- Interruption of rehabilitation treatment (transfer to an acute care hospital) for more than 14 days
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 |
|---|---|---|
| Simplified Evaluation of CONsciousness Disorders (SECONDs)The Simplified Evaluation of CONsciousness Disorders (SECONDs) is a structured behavioral assessment tool designed for the rapid evaluation of patients with disorders of consciousness. | Behavioural | Patients with Disorders of Consciousness |
| Coma Recovery Scale-Revised (CRS-R)The Coma Recovery Scale-Revised (CRS-R) is a standardized behavioral assessment tool used to evaluate the level of consciousness in patients with severe brain injury. It consists of six subscales assessing auditory, visual, motor, oromotor/verbal, communication, and arousal functions. | Behavioural | Patients with Disorders of Consciousness |
Primary outcome
Agreement Between the "Simplified Evaluation of CONsciousness Disorders" (SECONDs; Range: 0-8) and the "Coma Recovery Scale-Revised" (CRS-R; Range: 0-23)
Time frame: 6-8 days after admission to neurological rehabilitation
Categorical agreement in clinical classification of level of consciousness (Unresponsive Wakefulness Syndrome [UWS], Minimally Conscious State [MCS], Emerged from Minimally Conscious State [eMCS], No Disorder of Consciousness [non-DoC]) between the Simplified Evaluation of CONsciousness Disorders (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).
3 secondary outcomes
Diagnostic Stability in Patients Initially Classified as UWS
Time frame: 6-8 days after admission to neurological rehabilitation
Prognostic Validity of the "Simplified Evaluation of CONsciousness Disorders" (SECONDs; Range: 0-8) for Long-Term Functional Outcome
Time frame: 12 months after admission.
Feasibility of the Simplified Evaluation of CONsciousness Disorders (SECONDs)
Time frame: 6-8 days after admission to neurological rehabilitation
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 11 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 19622138Schnakers C, Vanhaudenhuyse A, Giacino J, Ventura M, Boly M, Majerus S, Moonen G, Laureys S. Diagnostic accuracy of the vegetative and minimally conscious state: clinical consensus versus standardized neurobehavioral assessment. BMC Neurol. 2009 Jul 21;9:35. doi: 10.1186/1471-2377-9-35.
- 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.
Melanie Boltzmann, PhD principal investigator
BDH-Klinik Hessisch Oldendorf
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 Disorders of Consciousness Due to Severe Brain Injury and Minimally Conscious State, 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 6 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: looking for participants now, as of the sponsor's last update on 11 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?
Contact Melanie Boltzmann, PhD (+49 5152781256, m.boltzmann@bdh-klinik-hessisch-oldendorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between the "Simplified Evaluation of CONsciousness Disorders" (SECONDs; Range: 0-8) and the "Coma Recovery Scale-Revised" (CRS-R; Range: 0-23) (time frame: 6-8 days 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 NCT07456020, which also lists 2 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 11 Mar 2026.