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Assessment of Consciousness With CRS-R and SECONDs

Recruitingn/aAges 18 Years - anyAllBDH-Klinik Hessisch Oldendorf
NCT07456020 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
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
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What it tests

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

1 site
BDH-Klinik Hessisch Oldendorf
Hessisch Oldendorf, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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