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ACTIVE NOT RECRUITING
NCT04279431

Follow-up of MTBI Patients Discharged from the ED Using Standard Clinical Triage Including BrainScope One

Sponsor: BrainScope Company, Inc.

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

660

Start Date

2020-05-25

Completion Date

2024-09-30

Last Updated

2024-09-03

Healthy Volunteers

No

Interventions

DEVICE

EEG Recording

EEG recording acquired on BrainScope One device.

OTHER

Neurocognitive Tests

Cognitive performance tests performed on BrainScope One device.

OTHER

Clinician Evaluation

Clinician evaluation performed as part of standard of care at the clinical site.

OTHER

22-item CSI

Self assessed 22-item Concussion Symptom Inventory (CSI).

Locations (7)

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