Objective Brain Function Assessment of mTBI/Concussion in College Athletes

Completed

Conditions studied: Brain Injuries, Traumatic, Concussion, Mild, Concussion, Brain, Concussion, Intermediate, Concussion, Severe

In brief

This study (Part 1) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery. In addition, neuroimaging will be conducted at time of injury and following Return to Play (RTP).

Key facts

Study ID: NCT02477943
Run by: BrainScope Company, Inc.
People needed: 520
Starts: 2015-08-08
Expected to finish: 2017-07-31
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 qualify if…

Concussion-Injury subjects will be defined as follows: Any player who, based on independent clinical impression, is suspected of having suffered a concussion of any severity level, and on whom a routine clinical examination for concussion or head injury would have been conducted prior to implementation of this research protocol according to current standard practice.
If loss of consciousness, total duration less than <20 minutes
No evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment)
No hospital admission due to either head injury or collateral injuries for >24 hours.
GCS is between 13-15.

You may not qualify if…

Evidence of illicit drug usage
Do not speak or read English
Current CNS active prescription medications, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD)
Skull abnormalities, e.g. metal plate
History of brain surgery or neurological disease.

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 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

Full record on ClinicalTrials.gov

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