Further Psychometric Data for the Reliability and the Diagnostic Validity of CRS-R

NCT03126929 | Completed DMC

• 1 other identifier: 2012/026/B
• Study Type: observational
• Target: 169
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to provide, in a large sample, further psychometric data as regards the internal consistency, the test-retest reliability and the diagnostic validity of the Coma Recovery Scale-Revised (CRS-R).

Conditions

Minimally Conscious State; Vegetative State

Keywords

disorders of consciousness; Vegetative state; Minimally conscious state; Emergence from MCS; Coma Recovery Scale-Revised

Outcome Measures

Primary Outcomes (1)

• Coma Recovery Scale-Revised for assess the level of consciousness

  Rater Measured the score of Coma Recovery Scale-Revised(CRS-R) within 24h. The CRS-R consists of 23 items grouped in six subscales addressing auditory, visual, motor, oromotor, communication and arousal functions. The lowest item on each subscale represents reflexive activity while the highest items represent cognitively-mediated behaviors.

  24 hours(1 day)

Study Arms (3)

Vegetative state

patients lack awareness of self and environment even in the presence for eye-opening and sleep-wake cycles using CRS-R and GCS

Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma Scale

Minimally conscious state

Patients display inconsistent, but reproducible and discernible signs of awareness using CRS-R and GCS

Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma Scale

Emergence from MCS

Patients regain accurate communication and/or functional use of objects using CRS-R and GCS

Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma Scale

Interventions

Coma Recovery Scale-Revised and Glasgow Coma Scale DIAGNOSTIC_TEST

Patients have been assessed with both the Coma Recovery Scale-Revised(CRS-R) and the Glasgow Coma Scale(GCS)

Emergence from MCS; Minimally conscious state; Vegetative state

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators chosen patients with VS, MCS, EMCS

You may qualify if:

• age above 18 years old
• any etiology
• pre-screening performed by the referent physician comforting the presence of a disorder of consciousness in accordance with international diagnostic criteria for VS, MCS or emergence from MCS (EMCS)

You may not qualify if:

• neuromuscular blocking agents or sedative drugs administered within the prior 24 hours
• no documented history of a prior coma
• critical illness or unstable medical condition

Sponsors & Collaborators

• Hangzhou Normal University: lead

MeSH Terms

Conditions

Persistent Vegetative State; Consciousness Disorders

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nurse-in-charge

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 25, 2017
• Study Start: March 1, 2012
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share