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.

NCT Number	NCT07456020
Lead Sponsor	BDH-Klinik Hessisch Oldendorf
Conditions	Disorders of Consciousness Due to Severe Brain Injury, Minimally Conscious State, Unresponsive Wakefulness Syndrome
Enrollment	110 participants
Start Date	2026-02-01
Primary Completion	2027-11-30 (estimated)
Study Completion	2028-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-11