Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe Traumatic Brain Injury | We will administer Coma Recovery Scale-Revised (CRS-R) and the Coma Recovery Scale Revised For Accelerated Standardized Testing (CRSR-FAST) to patients in the intensive care unit who have impaired level of consciousness resulting from a severe traumatic brain injury. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coma Recovery Scale-Revised | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. 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, visual function, motor function, oromotor/verbal function, communication and arousal. Evidence of specific behaviors on these subscales provides a diagnosis of vegetative state, minimally conscious state (MCS), or emerged from MCS. The CRSR-FAST is an abbreviated version of the CRS-R. We tested concurrent validity by comparing CRS-R and CRSR-FAST diagnostic ratings using the simple kappa coefficient; values close to 0 indicate no agreement and values close to 1 indicate almost perfect agreement. We established an a priori threshold of ≥ 0.60 to indicate substantial validity | 48 hours |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| CRSR-FAST Test-Retest Reliability | CRSR-FAST test-retest reliability using Mak's ρ. The CRSR-FAST was administered twice by 2 blinded raters. Mak's ρ values close to 0 indicate no agreement and values close to 1 indicate almost perfect reliability. We established an a priori threshold of ≥ 0.60 to indicate substantial reliability | 48 hours |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
We will enroll adults with a impaired level of consciousness resulting from severe traumatic brain injury who are recovering in the intensive care unit.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15605342 | Background | 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. doi: 10.1016/j.apmr.2004.02.033. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Severe Traumatic Brain Injury | We will administer Coma Recovery Scale-Revised (CRS-R) and the Coma Recovery Scale Revised For Accelerated Standardized Testing (CRSR-FAST) to patients in the intensive care unit who have impaired level of consciousness resulting from a severe traumatic brain injury. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Severe Traumatic Brain Injury | We will administer Coma Recovery Scale-Revised (CRS-R) and the Coma Recovery Scale Revised For Accelerated Standardized Testing (CRSR-FAST) to patients in the intensive care unit who have impaired level of consciousness resulting from a severe traumatic brain injury. 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 5 items that address visual, motor and verbal/oromotor systems. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. 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, visual function, motor function, oromotor/verbal function, communication and arousal. Evidence of specific behaviors on these subscales provides a diagnosis of vegetative state, minimally conscious state (MCS), or emerged from MCS. The CRSR-FAST is an abbreviated version of the CRS-R. We tested concurrent validity by comparing CRS-R and CRSR-FAST diagnostic ratings using the simple kappa coefficient; values close to 0 indicate no agreement and values close to 1 indicate almost perfect agreement. We established an a priori threshold of ≥ 0.60 to indicate substantial validity | Posted | Number | Simple Kappa (SE) | 48 hours |
|
48 hours
This is an observational study with no intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Severe Traumatic Brain Injury | We will administer Coma Recovery Scale-Revised (CRS-R) and the Coma Recovery Scale Revised For Accelerated Standardized Testing (CRSR-FAST) to patients in the intensive care unit who have impaired level of consciousness resulting from a severe traumatic brain injury. 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. There were no adverse events. |
Not provided
Not provided
The full-length CRS-R was administered only one time while the CRSR-FAST was administered 3 times. Fluctuations in level of consciousness over 48 hours may have affected the full-length CRS-R assessment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yelena Bodien | Spaulding Rehabilitation Hospital | (617) 643-3956 | ybodien@mgh.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2023 | Jul 26, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| CRSR-FAST Interrater Reliability |
CRSR-FAST interrupter reliability using Mak's ρ. The CRSR-FAST was administered twice by the same rater. Mak's ρ values close to 0 indicate no agreement and values close to 1 indicate almost perfect reliability. We established an a priori threshold of ≥ 0.60 to indicate substantial reliability |
| 48 hours |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Severe Traumatic Brain Injury |
We will administer Coma Recovery Scale-Revised (CRS-R) and the Coma Recovery Scale Revised For Accelerated Standardized Testing (CRSR-FAST) to patients in the intensive care unit who have impaired level of consciousness resulting from a severe traumatic brain injury. 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. |
|
|
| Other Pre-specified | CRSR-FAST Test-Retest Reliability | CRSR-FAST test-retest reliability using Mak's ρ. The CRSR-FAST was administered twice by 2 blinded raters. Mak's ρ values close to 0 indicate no agreement and values close to 1 indicate almost perfect reliability. We established an a priori threshold of ≥ 0.60 to indicate substantial reliability | Posted | Number | Mak's ρ | 48 hours |
|
|
|
| Other Pre-specified | CRSR-FAST Interrater Reliability | CRSR-FAST interrupter reliability using Mak's ρ. The CRSR-FAST was administered twice by the same rater. Mak's ρ values close to 0 indicate no agreement and values close to 1 indicate almost perfect reliability. We established an a priori threshold of ≥ 0.60 to indicate substantial reliability | Posted | Number | Mak's ρ | 48 hours |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
Not provided
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |