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



Status:Active, not recruiting
Conditions:Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 29
Updated:8/15/2018
Start Date:February 9, 2017
End Date:March 2019

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

Performance will be assessed by comparing the output of the algorithms, which were developed
by correlating changes in brain electrical activity (EEG) and other measures of brain
function to mTBI (e.g. concussion) in the sports environment.

Injured athletes will be studied during the season at time of injury, and then longitudinally
weeks after injury. Matched controls will be tested following the same schedule as the
injured athletes.

- 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
We found this trial at
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Storrs, Connecticut 06269
Phone: 860-429-7720
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Phone: 585-275-2909
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Phone: 813-396-9094
University of South Florida The University of South Florida is a high-impact, global research university...
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Austin, Texas 78712
Phone: 512-475-8499
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Columbia, South Carolina 29208
Phone: 803-777-3169
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East Lansing, Michigan 48824
Phone: 517-353-2010
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Fayetteville, Arkansas 72701
Phone: 479-575-5262
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750 East Adams Street
Syracuse, New York 13210
Phone: 315-464-9966
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Syracuse, NY
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