Status:
RECRUITING
Assessment of Consciousness With CRS-R and SECONDs
Lead Sponsor:
BDH-Klinik Hessisch Oldendorf
Conditions:
Disorders of Consciousness Due to Severe Brain Injury
Minimally Conscious State
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
This prospective observational study is designed to evaluate the clinical utility and diagnostic performance of the Simplified Evaluation of CONsciousness Disorders (SECONDs) in a neurological rehabil...
Eligibility Criteria
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
Key Trial Info
Start Date :
February 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07456020
Start Date
February 1 2026
End Date
March 31 2028
Last Update
March 11 2026
Active Locations (1)
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1
BDH-Klinik Hessisch Oldendorf
Hessisch Oldendorf, Lower Saxony, Germany, 31840