Assessment of Consciousness With CRS-R and SECONDs (AssessConsc)

March 9, 2026 updated by: BDH-Klinik Hessisch Oldendorf

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Behavioral: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6-8 days after admission to neurological rehabilitation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Stability in Patients Initially Classified as UWS
Time Frame: 6-8 days after admission to neurological rehabilitation
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.
6-8 days after admission to neurological rehabilitation
Feasibility of the Simplified Evaluation of CONsciousness Disorders (SECONDs)
Time Frame: 6-8 days after admission to neurological rehabilitation
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.
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.
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).
12 months after admission.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BDH-Klinik Hessisch Oldendorf

Investigators

  • Principal Investigator: Melanie Boltzmann, PhD, BDH-Klinik Hessisch Oldendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12079-BO-S-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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