Objective Brain Function Assessment of mTBI/Concussion in College Athletes
NCT ID: NCT02477943
Last Updated: 2019-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
520 participants
OBSERVATIONAL
2015-08-08
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Injured and Matched Control Subject Pool
Injured subjects consist of athletes who are head injured and meet the inclusion/exclusion criteria. Injured subjects will be tested within 72 hours (3 days) of injury and at specified time points post injury. Matched control subjects will be tested at the same time intervals as the injured subject. BrainScope Battery will be performed at each time point and consists of the following components: brain electrical activity (EEG), neurocognitive performance assessment, balance/sway measurement, and clinical symptoms/assessments. In addition, a subset of injured and matched control subjects will receive advanced MRI/DTI neuroimaging at time of injury and following RTP.
BrainScope Ahead 200iD
The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and a balance/sway measurement. BrainScope Ahead 200iD device will be used to perform EEG.
Advanced MRI Neuroimaging
Diffusion tensor imaging (DTI) is a magnetic resonance imaging technique that enables the measurement of the restricted diffusion of water in tissue in order to produce neural tract images instead of using this data solely for the purpose of assigning contrast or colors to pixels in a cross sectional image.
Pre-Season and Post-Season Subject Pool
This subject pool will consist of uninjured (not head injured) contact and non-contact athletes and will be tested at two time points - pre-season and post-season. These subjects will perform the same BrainScope Battery as the injured and matched control subjects at each time points.
BrainScope Ahead 200iD
The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and a balance/sway measurement. BrainScope Ahead 200iD device will be used to perform EEG.
Interventions
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BrainScope Ahead 200iD
The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and a balance/sway measurement. BrainScope Ahead 200iD device will be used to perform EEG.
Advanced MRI Neuroimaging
Diffusion tensor imaging (DTI) is a magnetic resonance imaging technique that enables the measurement of the restricted diffusion of water in tissue in order to produce neural tract images instead of using this data solely for the purpose of assigning contrast or colors to pixels in a cross sectional image.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. If loss of consciousness, total duration less than \<20 minutes
2. No evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment)
3. No hospital admission due to either head injury or collateral injuries for \>24 hours.
4. GCS is between 13-15.
Exclusion Criteria
2. Do not speak or read English
3. Current CNS active prescription medications, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD)
4. Skull abnormalities, e.g. metal plate
5. History of brain surgery or neurological disease.
18 Years
25 Years
ALL
No
Sponsors
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United States Department of Defense
FED
BrainScope Company, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Leslie Prichep, Ph.D.
Role: STUDY_DIRECTOR
BrainScope Company, Inc.
Locations
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University of Arkansas
Fayetteville, Arkansas, United States
University of Connecticut
Storrs, Connecticut, United States
University of South Florida
Tampa, Florida, United States
Michigan State University
East Lansing, Michigan, United States
University of New Mexico
Albuquerque, New Mexico, United States
University of Rochester Medical Center
Rochester, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
University of South Carolina
Columbia, South Carolina, United States
University of Texas - Austin
Austin, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Countries
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References
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Covassin T, McGowan AL, Bretzin AC, Anderson M, Petit KM, Savage JL, Katie SL, Elbin RJ, Pontifex MB. Preliminary investigation of a multimodal enhanced brain function index among high school and collegiate concussed male and female athletes. Phys Sportsmed. 2020 Nov;48(4):442-449. doi: 10.1080/00913847.2020.1745717. Epub 2020 Mar 31.
Other Identifiers
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14-Ahead
Identifier Type: -
Identifier Source: org_study_id
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