An observational study in Disorders of Consciousness Due to Severe Brain Injury, Minimally Conscious State and Unresponsive Wakefulness Syndrome, sponsored by BDH-Klinik Hessisch Oldendorf. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by BDH-Klinik Hessisch Oldendorf · Observational
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.
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 rehabilitation setting. The study aims to assess whether the implementation of SECONDs improves diagnostic accuracy in patients with disorders of consciousness during the subacute phase after severe acquired brain injury.
Participants will undergo structured behavioral assessment using SECONDs as part of the study protocol. Diagnostic classifications derived from SECONDs will be analyzed with regard to their internal consistency and clinical plausibility within the rehabilitation context.
To examine prognostic validity, functional outcome will be assessed 12 months after the initial evaluation. Follow-up data will be collected through structured telephone interviews with relatives or legal representatives. Functional status will be systematically documented in order to determine the predictive value of SECONDs classifications for long-term clinically relevant outcomes.
The study seeks to contribute to optimizing diagnostic procedures in disorders of consciousness and to strengthen the evidence base for time-efficient behavioral assessment tools in routine neurorehabilitation practice.
88 studies on the registry are indexed under Persistent Vegetative State; 20 are open to participants now.
This study's planned enrollment of 110 is above the median of 80 across 31 observational studies indexed under Persistent Vegetative State.
Browse Persistent Vegetative State studies →BDH-Klinik Hessisch Oldendorf is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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The study population consists of adult patients with severe acquired brain injury admitted to a neurological early rehabilitation program. Eligible participants present with a disorder of consciousness in the subacute phase (within 90 days after the index event) and require intensive or monitored medical care. Underlying etiologies include anoxic, traumatic, or vascular brain injury. Patients are characterized by severe functional impairment, as reflected by a low Early Rehabilitation Barthel Index score at admission.
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Exclusion Criteria:
Adult patients with severe acquired brain injury diagnosed with a disorder of consciousness (e.g., unresponsive wakefulness syndrome or minimally conscious state) undergoing structured behavioral assessment in a neurological rehabilitation setting.
Behavioral: Simplified Evaluation of CONsciousness Disorders (SECONDs) · Behavioral: Coma Recovery Scale-Revised (CRS-R)
The Simplified Evaluation of CONsciousness Disorders (SECONDs) is a structured behavioral assessment tool designed for the rapid evaluation of patients with disorders of consciousness.
The Coma Recovery Scale-Revised (CRS-R) is a standardized behavioral assessment tool used to evaluate the level of consciousness in patients with severe brain injury. It consists of six subscales assessing auditory, visual, motor, oromotor/verbal, communication, and arousal functions.
Agreement Between the "Simplified Evaluation of CONsciousness Disorders" (SECONDs; Range: 0-8) and the "Coma Recovery Scale-Revised" (CRS-R; Range: 0-23)
Categorical agreement in clinical classification of level of consciousness (Unresponsive Wakefulness Syndrome \[UWS\], Minimally Conscious State \[MCS\], Emerged from Minimally Conscious State \[eMCS\], No Disorder of Consciousness \[non-DoC\]) between the Simplified Evaluation of CONsciousness Disorders (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).
Time frame: 6-8 days after admission to neurological rehabilitation
Diagnostic Stability in Patients Initially Classified as UWS
Rate of diagnostic reclassification following repeated behavioral assessment on two consecutive days in patients initially diagnosed with Unresponsive Wakefulness Syndrome (UWS). Misdiagnosis rate is defined as the proportion of patients whose level of consciousness is reclassified into a different diagnostic category (e.g., from UWS to Minimally Conscious State \[MCS\]) upon repeat measurement.
Time frame: 6-8 days after admission to neurological rehabilitation
Prognostic Validity of the "Simplified Evaluation of CONsciousness Disorders" (SECONDs; Range: 0-8) for Long-Term Functional Outcome
Predictive value of baseline classification using the Simplified Evaluation of CONsciousness Disorders (SECONDs; ; Range: 0-8) for functional outcome at 12 months after admission, as measured by the Glasgow Outcome Scale-Extended (GOSE; Range: 1-8).
Time frame: 12 months after admission.
Feasibility of the Simplified Evaluation of CONsciousness Disorders (SECONDs)
Assessment of clinical feasibility of SECONDs in a neurological rehabilitation setting, including test completion rate, administration time per assessment, and occurrence of premature test termination or technical/practical difficulties.
Time frame: 6-8 days after admission to neurological rehabilitation
Plan to share: No
Started Feb 2026 (actual). Primary completion is estimated for Nov 2027, 21 months after the start.
Of 16 observational studies under Persistent Vegetative State, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 60. This study's planned 21 months is below that.
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