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

NCT04279431 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 660

Last updated 2024-09-03

No results posted yet for this study

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.

Conditions

  • TBI (Traumatic Brain Injury)
  • Concussion, Brain
  • MTBI - Mild Traumatic Brain Injury
  • Closed Head Injury

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).

Sponsors & Collaborators

  • BrainScope Company, Inc.

    lead INDUSTRY

Principal Investigators

  • Leslie S Prichep, Ph.D. · BrainScope Company, Inc.

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-25
Primary Completion
2024-09-01
Completion
2024-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04279431 on ClinicalTrials.gov