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Assessment of Consciousness With CRS-R and SECONDs

NCT07456020 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2026-03-11

No results posted yet for this study

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 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.

Conditions

  • Disorders of Consciousness Due to Severe Brain Injury
  • Minimally Conscious State
  • Unresponsive Wakefulness Syndrome

Interventions

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.

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.

Sponsors & Collaborators

  • BDH-Klinik Hessisch Oldendorf

    lead OTHER

Principal Investigators

  • Melanie Boltzmann, PhD · BDH-Klinik Hessisch Oldendorf

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-11-30
Completion
2028-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07456020 on ClinicalTrials.gov