Validation of Brain Function Assessment Algorithm for mTBI/Concussion in College Athletes
Completed
Conditions studied: Brain Injuries, Traumatic, Concussion, Mild, Concussion, Brain, Concussion, Severe, Concussion, Intermediate
In brief
This study is Part 1 of data collection from 18-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT03671083 (Part 2 with subject age range 13-25 years) for the final analyses of validation of the algorithms.
Key facts
- Study ID
- NCT02957461
- Run by
- BrainScope Company, Inc.
- People needed
- 420
- Starts
- 2017-02-03
- Expected to finish
- 2018-03-02
- Last updated by the study team
- 2019-05-23
Who can join
Age: 18 and older, up to 25. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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 only
- Prior history of concussion in the last year - for Matched Control subjects only
Where it is running
- 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 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
Full record on ClinicalTrials.gov
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