Validation of Brain Function Assessment Algorithm for mTBI From Injury to Rehabilitation in College Athletes

Description

This study is designed to validate the performance of the algorithms to be used in future commercial device.

Study Start Date

February, 09 2017

Estimated Completion Date

March 2018

Interventions

  • Device: BrainScope Battery

Study ID

BrainScope Company, Inc. -- 18-Ahead

Status

Unknown

Trial ID

NCT02957461

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

220

Sponsor

BrainScope Company, Inc.

  • Inclusion Criteria

    • Age 18
    • 29 years old
    • Time of injury within 72 hours of BrainScope Battery
    • for injured subjects
    • No evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment)
    • for injured subjects
    • No hospital admission due to either head injury or collateral injuries for >24 hours
    • for injured subjects

    Exclusion Criteria

    • Previously enrolled as an Injured or Matched Control subject in the BrainScope Algorithm Development Study
    • Current CNS active prescription medications taken daily, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD)
    • Forehead, scalp or skull abnormalities that prevents headset application or EEG data collection
    • History of brain surgery or neurological disease
    • Pregnant women
    • Do not speak or read English
    • Loss of consciousness ? 20 minutes related to the concussion injury
    • for injured subjects
    • Prior history of concussion in the last year
    • for Matched Control subjects only
  • Gender

    All

    Ages

    18 Years to 29 Years

    Accepts Healthy Volunteers

    No

    Study Locations and Contact Information (29)

    Study Location Distance Name Phone Email
    University of Connecticut - Storrs, Connecticut 70.2 miles Douglas Casa PhD 860-429-7720 douglas.casa@uconn.edu
    University of Connecticut - Storrs, Connecticut 70.2 miles Douglas Casa PhD 860-429-7720 douglas.casa@uconn.edu
    University of Connecticut - Storrs, Connecticut 70.2 miles Douglas Casa PhD 860-429-7720 douglas.casa@uconn.edu
    University of Connecticut - Storrs, Connecticut 70.2 miles Douglas Casa PhD 860-429-7720 douglas.casa@uconn.edu
    SUNY Upstate Medical University - Syracuse, New York 259.8 miles Christopher Neville PhD 315-464-9966 nevillec@upstate.edu
    SUNY Upstate Medical University - Syracuse, New York 259.8 miles Christopher Neville PhD 315-464-9966 nevillec@upstate.edu
    SUNY Upstate Medical University - Syracuse, New York 259.8 miles Christopher Neville PhD 315-464-9966 nevillec@upstate.edu
    SUNY Upstate Medical University - Syracuse, New York 259.8 miles Christopher Neville PhD 315-464-9966 nevillec@upstate.edu
    University of Rochester Medical Center - Rochester, New York 335.8 miles Kian MerchantBorna 585-275-2909 None
    University of Rochester Medical Center - Rochester, New York 335.8 miles Kian MerchantBorna 585-275-2909 None
    University of Rochester Medical Center - Rochester, New York 335.8 miles Kian MerchantBorna 585-275-2909 None
    University of Rochester Medical Center - Rochester, New York 335.8 miles Kian MerchantBorna 585-275-2909 None
    Michigan State University - East Lansing, Michigan 683.3 miles Tracey Covassin PhD 517-353-2010 covassin@msu.edu
    Michigan State University - East Lansing, Michigan 683.3 miles Tracey Covassin PhD 517-353-2010 covassin@msu.edu
    Michigan State University - East Lansing, Michigan 683.3 miles Tracey Covassin PhD 517-353-2010 covassin@msu.edu
    Michigan State University - East Lansing, Michigan 683.3 miles Tracey Covassin PhD 517-353-2010 covassin@msu.edu
    University of South Carolina - Columbia, South Carolina 791.8 miles Susan Yeargin PhD ATC 803-777-3169 syeargin@mailbox.sc.edu
    University of South Carolina - Columbia, South Carolina 791.8 miles Susan Yeargin PhD ATC 803-777-3169 syeargin@mailbox.sc.edu
    University of South Carolina - Columbia, South Carolina 791.8 miles Susan Yeargin PhD ATC 803-777-3169 syeargin@mailbox.sc.edu
    University of South Carolina - Columbia, South Carolina 791.8 miles Susan Yeargin PhD ATC 803-777-3169 syeargin@mailbox.sc.edu
    University of South Florida - Tampa, Florida 1,178.7 miles Gianluca Del Rossi 813-396-9094 None
    University of Arkansas - Fayetteville, Arkansas 1,306.5 miles Robert J Elbin PhD 479-575-5262 rjelbin@uark.edu
    University of Arkansas - Fayetteville, Arkansas 1,306.5 miles Robert J Elbin PhD 479-575-5262 rjelbin@uark.edu
    University of Arkansas - Fayetteville, Arkansas 1,306.5 miles Robert J Elbin PhD 479-575-5262 rjelbin@uark.edu
    University of Arkansas - Fayetteville, Arkansas 1,306.5 miles Robert J Elbin PhD 479-575-5262 rjelbin@uark.edu
    University of Texas Austin - Austin, Texas 1,695.2 miles David Schnyer PhD 512-475-8499 schnyer@utexas.edu
    University of Texas Austin - Austin, Texas 1,695.2 miles David Schnyer PhD 512-475-8499 schnyer@utexas.edu
    University of Texas Austin - Austin, Texas 1,695.2 miles David Schnyer PhD 512-475-8499 schnyer@utexas.edu
    University of Texas Austin - Austin, Texas 1,695.2 miles David Schnyer PhD 512-475-8499 schnyer@utexas.edu

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