Assessment of Consciousness With CRS-R and SECONDs

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBDH-Klinik Hessisch Oldendorf

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Simplified Evaluation of CONsciousness Disorders (SECONDs)
  • Coma Recovery Scale-Revised (CRS-R)

Treatment groups

110 Participants
are divided into 1 treatment group

Sponsors and collaborators