Validity and Feasibility of the CRSR-FAST

Last updated: August 5, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Completed

Phase

N/A

Condition

Traumatic Brain Injury

Memory Loss

Neurologic Disorders

Treatment

Coma Recovery Scale-Revised

Clinical Study ID

NCT03549572
2015P000147
  • Ages > 18
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

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 byan external mechanical force),

  • Be within 3 weeks of injury

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

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

Exclusion

Exclusion Criteria:

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

  • Physician orders for comfort measures only

Study Design

Total Participants: 56
Treatment Group(s): 1
Primary Treatment: Coma Recovery Scale-Revised
Phase:
Study Start date:
August 28, 2018
Estimated Completion Date:
December 04, 2022

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.