Checking consciousness using the CRS-R and a shorter SECONDs checklist
Official title: Assessment of Consciousness After Severe Brain Injury: Comparison of CRS-R and SECONDs
Run by BDH-Klinik Hessisch Oldendorf · NCT07456020 · Data updated 2026-11-12
This tests whether a shorter checklist called SECONDs can help doctors quickly and accurately determine consciousness level in people recovering from severe brain injury.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | BDH-Klinik Hessisch Oldendorf Academic / other |
| Locations | 1 site (Hessisch Oldendorf, Lower Saxony) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | November 30, 2027 |
| Study ends | March 31, 2028 |
| Registry record updated | March 11, 2026 |
| Trial ID | NCT07456020 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients within 90 days of a severe anoxic, traumatic, or vascular brain injury admitted to ICU or high-dependency care with low early rehabilitation scores (ERBI < 30), who are not sedated, have no prior brain injury or major psychiatric disorder, and have sufficient language comprehension.
✕Probably not a fit
Patients with prior brain injury, major psychiatric disorders, impaired language comprehension (or insufficient German), ongoing sedation, prolonged interruptions in rehabilitation, or isolation precautions are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational study in a neurological rehabilitation setting comparing a shorter bedside tool (SECONDs) with the established Coma Recovery Scale-Revised (CRS-R). Patients in the subacute phase after severe acquired brain injury receive structured behavioral assessments with SECONDs as part of routine care, and diagnostic classifications are analyzed for internal consistency and clinical plausibility. Functional outcome is measured 12 months after the initial evaluation using structured telephone interviews with relatives or legal representatives. The goal is to determine whether SECONDs classifications predict long-term outcomes and could make routine consciousness screening more time-efficient.
Why it matters
Potential benefit: If successful, SECONDs could make accurate consciousness checks faster and easier in rehabilitation, helping guide care decisions and prognosis.
How similar studies have gone: The CRS-R is an established gold standard and repeated behavioral testing has improved diagnostic accuracy in prior work, but SECONDs is a newer, shorter tool with limited prior validation.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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BDH-Klinik Hessisch Oldendorf
Hessisch Oldendorf, Lower Saxony, Germany Recruiting
Study contacts
- Principal investigator: Melanie Boltzmann, PhD — BDH-Klinik Hessisch Oldendorf
- Study coordinator: Melanie Boltzmann, PhD
- Email: m.boltzmann@bdh-klinik-hessisch-oldendorf.de
- Phone: +49 5152781256
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.