Actively Recruiting
Assessment of Consciousness With CRS-R and SECONDs
Led by BDH-Klinik Hessisch Oldendorf · Updated on 2026-03-11
110
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Assessment of Consciousness With CRS-R and SECONDs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admission to an intensive care unit (ICU) or intermediate/high-dependency care unit
- Brain injury caused by anoxic, traumatic, or vascular events
- Less than 90 days since the brain injury event
- Early Rehabilitation Barthel Index (ERBI) score less than 30 points
You will not qualify if you...
- History of prior brain injury
- Pre-existing major psychiatric disorder
- Impaired language comprehension such as insufficient German proficiency or aphasia
- Ongoing sedation during assessment
- Rehabilitation treatment interrupted for more than 14 days due to transfer to acute care hospital
- Isolation precautions because of multidrug-resistant organisms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
BDH-Klinik Hessisch Oldendorf
Hessisch Oldendorf, Lower Saxony, Germany, 31840
Actively Recruiting
Research Team
M
Melanie Boltzmann, PhD
CONTACT
S
Simone B. Jenner
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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