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

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ClinicalTrials.gov Identifier: NCT02367300
Recruitment Status : Completed
First Posted : February 20, 2015
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
BrainScope Company, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Brain Injuries Device: BrainScope Ahead 200

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 Design
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Study Type : Observational
Actual Enrollment : 981 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation Of Point-Of-Care TBI Detection System For Head Injured Patients
Study Start Date : February 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016
Groups and Cohorts
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Intervention Details:
  • Device: BrainScope Ahead 200
    A single-use, proprietary headset containing pre-gelled electrodes will be placed on the subject's forehead according to the standard locations of the modified International 10/20 system. Subjects will undergo approximately 5 minutes of eyes closed brain electrical activity recording.

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate the utility of creating a three-tier system for CT+ (CT-, Equivocal Zone (require close observation), and CT+). [ Time Frame: 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02367300


Locations
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United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Georgia
Emory University- Grady Hospital
Atlanta, Georgia, United States, 30303
United States, Maryland
R Cowley Shock Trauma Hospital
Baltimore, Maryland, United States, 21201
United States, Michigan
Wayne State University - Detroit Receiving Hospital
Detroit, Michigan, United States, 48235
Wayne State University - Sinai Grace Hospital
Detroit, Michigan, United States, 48235
United States, Missouri
Washington University - Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
UT-Houston Health Science Center
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
BrainScope Company, Inc.
Investigators
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Principal Investigator: Douglas C Oberly BrainScope Company, Inc.
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: BrainScope Company, Inc.
ClinicalTrials.gov Identifier: NCT02367300    
Other Study ID Numbers: 22-Ahead
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries