Validation Of TBI Detection System For Head Injured Patients (B-AHEAD III)

June 17, 2016 updated by: BrainScope Company, Inc.

Validation Of Point-Of-Care TBI Detection System For Head Injured Patients

A prospective, non-randomized trial to validate the database of brain electrical activity recordings and clinical information collected from patients who present to the ED following closed head injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to validate the clinical utility of the BrainScope technology for the acute identification of structural brain injuries in a TBI population presenting to the ED with mild symptoms, following closed head injury.

Study Type

Observational

Enrollment (Actual)

981

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University- Grady Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • R Cowley Shock Trauma Hospital
    • Michigan
      • Detroit, Michigan, United States, 48235
        • Wayne State University - Sinai Grace Hospital
      • Detroit, Michigan, United States, 48235
        • Wayne State University - Detroit Receiving Hospital
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University - Barnes Jewish Hospital
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Houston, Texas, United States, 77030
        • UT-Houston Health Science Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who are suspected of a traumatic, closed head injury within 72 hours will be recruited from patients who enter the Emergency Department at hospitals that are participating as clinical sites for this study.

Description

Inclusion Criteria:

  • Subjects who are admitted to the ED and are suspected of a traumatic, closed head injury within 72 hours. The patient will have a GCS 12-15 upon arrival to the ED even if GCS was lower prior to arrival to the ED (e.g., at the time of injury).

Exclusion Criteria:

  • Subjects will be excluded who have forehead, scalp, or skull abnormalities or other conditions that would prevent correct application of the electrode headset on the skin.

  • In addition,

    • subjects with dementia,
    • Parkinson's Disease,
    • multiple sclerosis,
    • seizure disorder,
    • brain tumors,
    • history of brain surgery,
    • evidence of acute psychosis,
    • substance dependence,
    • history of TIA or stroke within the last year,
    • currently receiving dialysis or in end-stage renal disease,
    • active fever defined as greater than 100 degrees F or 37.7 degrees C,
    • current condition is "critical" in the opinion of the investigator,
    • subject is suffering from an open head injury,
    • subject requires advanced airway management (i.e. mechanical ventilation),
    • currently receiving procedural sedation medications.
  • Subjects below the age of 18 years, and prisoners will not be eligible for study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary objective of this study is to validate the clinical utility of the BrainScope Ahead 300 device for the acute identification of structural brain injuries in the TBI population, following closed head injury.
Time Frame: 30 days
The co-primary endpoints for this study are the sensitivity/specificity pair for CT+ identified by the Ahead 300 algorithm classification.
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To demonstrate the utility of the EEG normality indicator (NI) score from a given subject presented as a percentile of the normal population and an indicator score.
Time Frame: 30 days
30 days
To evaluate the utility of creating a three-tier system for CT+ (CT-, Equivocal Zone (require close observation), and CT+).
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BrainScope Company, Inc.

Investigators

  • Principal Investigator: Douglas C Oberly, BrainScope Company, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

February 19, 2015

First Posted (Estimate)

February 20, 2015

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 17, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-Ahead

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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