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NCT03549572 · ClinicalTrials.gov registry record
Validity and Feasibility of the CRSR-FAST
A clinical trial of Traumatic Brain Injury and Disorder of Consciousness, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 56
- Enrollment target
- 1
- Study location
NCT03549572: Completed study of Traumatic Brain Injury and Disorder of Consciousness, sponsored by Massachusetts General Hospital.
NCT03549572 is a study of Traumatic Brain Injury and Disorder of Consciousness that has completed, run by Massachusetts General Hospital. The registered enrollment target is 56 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03549572, a study of Traumatic Brain Injury and Disorder of Consciousness, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 56 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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 arous
Conditions Studied
Interventions
- BEHAVIORAL Coma Recovery Scale-Revised
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2018-08-28 |
| Est. Completion | 2022-12-04 |
What the finished NCT03549572 record still lists
NCT03549572 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which Coma Recovery Scale-Revised is the first listed.
NCT03549572 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03549572 about?
NCT03549572 is a clinical study titled "Validity and Feasibility of the CRSR-FAST". 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...
What is the current status of trial NCT03549572?
This trial is currently completed. The enrollment target is 56 participants. The study started on 2018-08-28. Estimated completion is 2022-12-04.
What conditions does trial NCT03549572 study?
This clinical trial studies the following conditions: Traumatic Brain Injury, Disorder of Consciousness.
What interventions are being tested in trial NCT03549572?
The interventions under investigation include: Coma Recovery Scale-Revised (BEHAVIORAL).
Who is sponsoring clinical trial NCT03549572?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03549572 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03549572's enrollment target sits among peer trials
56 113th of 171 higher than 59 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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