NCT07456020 Assessment of Consciousness With CRS-R and SECONDs
| NCT ID | NCT07456020 |
| Status | Recruiting |
| Phase | — |
| Sponsor | BDH-Klinik Hessisch Oldendorf |
| Condition | Disorders of Consciousness Due to Severe Brain Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2026-02-01 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Melanie Boltzmann, PhD
PRINCIPAL INVESTIGATOR
BDH-Klinik Hessisch Oldendorf
Frequently Asked Questions
Who can join the NCT07456020 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Disorders of Consciousness Due to Severe Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07456020 currently recruiting?
Yes, NCT07456020 is actively recruiting participants. Contact the research team at m.boltzmann@bdh-klinik-hessisch-oldendorf.de for enrollment information.
Where is the NCT07456020 trial being conducted?
This trial is being conducted at Hessisch Oldendorf, Germany.
Who is sponsoring the NCT07456020 clinical trial?
NCT07456020 is sponsored by BDH-Klinik Hessisch Oldendorf. The principal investigator is Melanie Boltzmann, PhD at BDH-Klinik Hessisch Oldendorf. The trial plans to enroll 110 participants.