Actively Recruiting

Age: 18Years +
All Genders
ID07456020

Assessment of Consciousness After Severe Brain Injury: Comparison of CRS-R and SECONDs

Led by BDH-Klinik Hessisch Oldendorf · Updated on 2026-03-11

110

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating diagnostic methods to better assess consciousness levels in patients with severe brain injury. This study focuses on improving the accuracy and feasibility of evaluating consciousness disorders, such as coma, Unresponsive Wakefulness Syndrome (UWS), and Minimally Conscious State (MCS). The study compares two behavioral assessment tools: the widely used Coma Recovery Scale-Revised (CRS-R) and a newer, shorter tool called the Simplified Evaluation of CONsciousness Disorders (SECONDs). Participants will undergo structured behavioral assessments using both the SECONDs and CRS-R tools during a neurological rehabilitation phase. The study will analyze the diagnostic consistency and clinical relevance of SECONDs compared to CRS-R, aiming to confirm whether SECONDs offers a reliable and quicker alternative for routine clinical use. The study also includes a follow-up 12 months later to evaluate long-term functional outcomes based on initial SECONDs assessments. During the study, patients will be assessed shortly after admission to rehabilitation (6-8 days) using both tools. Follow-up information will be collected via structured telephone interviews with relatives or legal representatives to monitor patients' functional status one year later. Researchers will measure agreement between SECONDs and CRS-R scores, diagnostic stability, prognostic value for long-term outcomes, and the practical feasibility of SECONDs in clinical settings.

CONDITIONS

Brief Title

Assessment of Consciousness With CRS-R and SECONDs

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admission to an intensive care unit (ICU) or intermediate/high-dependency care unit
  • Brain injury caused by anoxic, traumatic, or vascular events
  • Time since brain injury less than 90 days
  • Early Rehabilitation Barthel Index (ERBI) score below 30 points
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • History of prior brain injury
  • Major psychiatric disorder before brain injury
  • Difficulty understanding language (e.g., insufficient German proficiency or aphasia)
  • Current sedation during assessment
  • Rehabilitation interrupted for more than 14 days due to hospital transfer
  • Isolation precautions for multidrug-resistant infections

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 6 to 8 days after admission to neurological rehabilitation

Participants undergo structured behavioral assessments using the Simplified Evaluation of CONsciousness Disorders (SECONDs) and the Coma Recovery Scale-Revised (CRS-R) to evaluate consciousness levels during neurological rehabilitation.

1 to 2 visits depending on assessments

Long-term Monitoring

Duration - 12 months after admission

Participants’ functional outcomes are assessed through structured telephone interviews with relatives or legal representatives to evaluate prognostic validity of the SECONDs classification.

1 follow-up telephone interview

Trial Site Locations

Total: 1 location

1

BDH-Klinik Hessisch Oldendorf

Hessisch Oldendorf, Lower Saxony, Germany, 31840

Actively Recruiting

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Research Team

M

Melanie Boltzmann, PhD

S

Simone B. Jenner

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Diagnostic accuracy of the vegetative and minimally conscious state: clinical consensus versus standardized neurobehavioral assessment.

Caroline Schnakers, Audrey Vanhaudenhuyse, Joseph Giacino...

https://pubmed.ncbi.nlm.nih.gov/19622138