Validity and Feasibility of the CRSR-FAST

Traumatic Brain Injury Clinical Trial

— CRSR-FAST  

Official title:

Validation and Feasibility of the Coma Recovery Scale-Revised for Accelerated Standardized Assessment (CRSR-FAST): a Brief, Standardized Assessment Instrument to Monitor Recovery of Consciousness in the Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03549572
• Other study ID #: 2015P000147
• Status: Recruiting
• Start date: August 28, 2018
• Est. completion date: October 1, 2022

Study information

• Verified date: December 2018
• Source: Massachusetts General Hospital
• Contact: Yelena Bodien, PhD
• Phone: 6179526308
• Email: ybodien[@]partners.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The CRS-R is a standardized and validated bedside assessment of conscious awareness. It is used routinely for diagnosis and prognosis of patients with disorders of consciousness (DOC) as well as in research settings. One limitation of the CRS-R is the lengthy administration time required to obtain a total score. Administration time can vary from approximately 15-30 minutes, depending on the patient's level of responsiveness. For this reason, the CRS-R is rarely administered in the acute hospital setting. Less time-consuming scales and metrics are used to assess conscious awareness in the acute hospital/ICU setting, but they lack specificity and sensitivity and have not been validated, increasing the potential for misdiagnosis. In conjunction with the developers of the Neuroscore (an unpublished, abbreviated version of the CRS-R), we have developed the CRSR-FAST and aim to test its validity, inter- and intra- rater reliability. We anticipate that, compared with the CRS-R, the CRSR-FAST will be less time-consuming to administer and score, but will maintain a high level of sensitivity to detecting signs of consciousness in severely brain injured patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Fluent in English

• Surrogate available to provide informed consent

• History of severe acquired brain injury

• Sustained a traumatic brain injury (TBI, defined by damage to brain tissue caused by an external mechanical force),

• Be within 3 weeks of injury

• Have a total Glasgow Outcome Scale (GCS) score <9 within the first 48 hours of injury,

• Be unable to follow simple commands consistently at the time of enrollment

Exclusion Criteria:

• History of developmental, neurologic, or major psychiatric disorder resulting in ongoing functional disability up to the time of the current injury

• Physician orders for comfort measures only

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Consciousness Disorders
• Disorder of Consciousness
• Traumatic Brain Injury

Intervention

Behavioral:
• Coma Recovery Scale-Revised
Patients will be assessed using the CRS-R and the CRSR-FAST. The CRS-R is a standardized neurobehavioral rating scale that consists of 23 items organized into six subscales that address arousal, auditory, visual, motor, oromotor/verbal, and communication systems. Each subscale is organized hierarchically, with lower items representing reflexive behaviors and higher items indicative of cognitively-mediated behaviors. Reliability and validity have been demonstrated in multiple studies. The CRSR-FAST consists of 10 items organized into 4 subscales that address arousal, visual, motor and verbal/oromotor systems. Each subscale is organized hierarchically, with lower items representing reflexive behaviors and higher items indicative of cognitively-mediated behaviors.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Giacino JT, Kalmar K, Whyte J. The JFK Coma Recovery Scale-Revised: measurement characteristics and diagnostic utility. Arch Phys Med Rehabil. 2004 Dec;85(12):2020-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Agreement	Diagnostic agreement between the Coma Recovery Scale-Revised (CRS-R) and the CRSR For Accelerated Standardized Testing (CRSR-FAST). The CRS-R is a standardized neurobehavioral rating scale used to monitor recovery of consciousness in persons with severe traumatic brain injury. Total scores on the CRS-R range from 0 to 23 with high scores generally indicating greater recovery. Six subscales on the CRS-R are summed to provide the total score: auditory function (0-4), visual function (0-5), motor function (0-6), oromotor/verbal function (0-3), communication (0-2) and arousal (0-3). Evidence of specific behaviors on these subscales provides a diagnosis of vegetative state, minimally conscious state, or emerged from minimally conscious state. The CRSR-FAST is an abbreviated version of the CRS-R that includes select items from the auditory, visual, motor, and oromotor subscales.	Within 3 weeks of injury