Follow-up of MTBI Patients Discharged from the ED Using Standard Clinical Triage Including BrainScope One
Running, not enrolling
Conditions studied: TBI (Traumatic Brain Injury), Concussion, Brain, MTBI - Mild Traumatic Brain Injury, Closed Head Injury
In brief
The purpose of the study is to validate the clinical outcome in patients with closed head injuries (GCS 14-15, ages 18-85) who are being evaluated for head trauma, integrating the BrainScope One structural injury classifier (SIC) algorithm, with focus on SIC negative classification. In addition, to assess functional impairment (concussion) in these patients, results from Brain Function Index (BFI) or Concussion Index (CI) algorithms will be used for analysis.
Key facts
- Study ID
- NCT04279431
- Run by
- BrainScope Company, Inc.
- People needed
- 660
- Starts
- 2020-05-25
- Expected to finish
- 2024-09-30
- Last updated by the study team
- 2024-09-03
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Wayne State University - Detroit Receiving Hospital — Detroit, Michigan, United States
- Henry Ford Health System — Detroit, Michigan, United States
- Wayne State University - Sinai Grace Hospital — Detroit, Michigan, United States
- Beaumont Hospital — Royal Oak, Michigan, United States
- Beaumont Hospital — Troy, Michigan, United States
- Washington University - Barnes Jewish Hospital — St Louis, Missouri, United States
- El Paso Medical Center — El Paso, Texas, United States
Full record on ClinicalTrials.gov
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