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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 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.

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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.

Interventions

  • BEHAVIORAL Coma Recovery Scale-Revised

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2018-08-28
Est. Completion 2022-12-04

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT03549572

The ClinicalTrials.gov registry entry for NCT03549572 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (80% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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