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Validation of Brain Function Assessment Algorithm for mTBI From Injury to Rehabilitation in College Athletes
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.
EEG, neurocognitive performance and clinical data will be collected at time of injury (within 3 days) at clinically determined Return to Play (RTP) and 45 days after RTP, for the purpose of independently validating the performance of the algorithms developed in prior studies (NCT02477943, NCT02661633 and NCTXXXXXX). Data collected under this study will be combined with that collected under NCT03671083 for the final analyses of prospective algorithm performance in an independent population ages 13-25 years. Subjects will come from the sports and other populations of concussed individuals. They will be matched with controls i.e. not head injured subjects who will also undergo the same set of tests and the same time intervals as the injured subjects. An additional pool of uninjured (not head injured) subjects will be collected who will be assessed at a single time point.
Age
18 - 25 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
February 3, 2017
Primary Completion Date
January 31, 2018
Completion Date
March 2, 2018
Last Updated
May 23, 2019
420
ACTUAL participants
BrainScope Ahead 200iD
DEVICE
Lead Sponsor
BrainScope Company, Inc.
Collaborators
Data Source & Attribution
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