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NCT Number: NCT07456020

Assessment of Consciousness With 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.

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Key information

Conditions

Disorders of Consciousness Due to Severe Brain Injury Brain Damage, Chronic Brain Diseases Brain Injuries Central Nervous System Diseases Consciousness Disorders Craniocerebral Trauma Mental Disorders Minimally Conscious State Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Persistent Vegetative State Signs and Symptoms Trauma, Nervous System Unconsciousness Unresponsive Wakefulness Syndrome Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simplified Evaluation of CONsciousness Disorders (SECONDs)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Melanie Boltzmann, PhD

CONTACT

[email protected]

+49 5152781256

Simone B. Jenner

CONTACT

[email protected]

+49 5152781215

Sponsors and collaborators

Lead sponsor

BDH-Klinik Hessisch Oldendorf

Other

Registry information

Official study title

Assessment of Consciousness After Severe Brain Injury: Comparison of CRS-R and SECONDs

Acronym: AssessConsc

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 6, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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