Assessment of Consciousness With CRS-R and SECONDs

NCT07456020 | Recruiting

• 1 other identifier: 12079-BO-S-2025
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Unresponsive Wakefulness Syndrome; Disorders of Consciousness Due to Severe Brain Injury; Minimally Conscious State

Keywords

Disorders of consciousness; Coma Recovery Scale-Revised; SECONDs; Acquired Brain Injury; Neurological rehabilitation; Critical ill patients

Outcome Measures

Primary Outcomes (1)

• 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).

  6-8 days after admission to neurological rehabilitation

Secondary Outcomes (3)

• Diagnostic Stability in Patients Initially Classified as UWS

  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

  12 months after admission.

• Feasibility of the Simplified Evaluation of CONsciousness Disorders (SECONDs)

  6-8 days after admission to neurological rehabilitation

Study Arms (1)

Patients with Disorders of Consciousness

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)

Interventions

Simplified Evaluation of CONsciousness Disorders (SECONDs) BEHAVIORAL

The Simplified Evaluation of CONsciousness Disorders (SECONDs) is a structured behavioral assessment tool designed for the rapid evaluation of patients with disorders of consciousness.

Patients with Disorders of Consciousness

Coma Recovery Scale-Revised (CRS-R) BEHAVIORAL

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.

Patients with Disorders of Consciousness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BDH-Klinik Hessisch Oldendorf: lead

Study Sites (1)

BDH-Klinik Hessisch Oldendorf

Hessisch Oldendorf, Lower Saxony, 31840, Germany

RECRUITING

Related Publications (2)

• Wannez S, Heine L, Thonnard M, Gosseries O, Laureys S; Coma Science Group collaborators. The repetition of behavioral assessments in diagnosis of disorders of consciousness. Ann Neurol. 2017 Jun;81(6):883-889. doi: 10.1002/ana.24962.

  PMID: 28543735 BACKGROUND

• Schnakers C, Vanhaudenhuyse A, Giacino J, Ventura M, Boly M, Majerus S, Moonen G, Laureys S. Diagnostic accuracy of the vegetative and minimally conscious state: clinical consensus versus standardized neurobehavioral assessment. BMC Neurol. 2009 Jul 21;9:35. doi: 10.1186/1471-2377-9-35.

  PMID: 19622138 BACKGROUND

MeSH Terms

Conditions

Persistent Vegetative State; Consciousness Disorders; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Unconsciousness; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Melanie Boltzmann, PhD

  BDH-Klinik Hessisch Oldendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie Boltzmann, PhD

CONTACT

+49 5152781256; m.boltzmann@bdh-klinik-hessisch-oldendorf.de

Simone B. Jenner

CONTACT

+49 5152781215; s.jenner@bdh-klinik-hessisch-oldendorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)