Objective Brain Function Assessment of mTBI/Concussion in College Athletes
- Conditions
- Concussion, SevereBrain Injuries, TraumaticConcussion, BrainConcussion, MildConcussion, Intermediate
- Interventions
- Device: BrainScope Ahead 200iDDevice: Advanced MRI Neuroimaging
- Registration Number
- NCT02477943
- Lead Sponsor
- BrainScope Company, Inc.
- Brief Summary
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).
- Detailed Description
Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. Matched controls will be tested following the same schedule as the injured athletes. In addition, the study will include an additional pool of contact and non-contact athletes who are not head injured and will be assessed prior to the season and then after the season has ended. This data will be used to populate a database for the purpose of deriving a multimodal concussion index.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 520
-
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Injured and Matched Control Subject Pool Advanced MRI Neuroimaging 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. Injured and Matched Control Subject Pool BrainScope Ahead 200iD 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. Pre-Season and Post-Season Subject Pool BrainScope Ahead 200iD 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.
- Primary Outcome Measures
Name Time Method Algorithm for Likelihood of being concussed 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP Create a database of brain electrical activity (EEG) and clinical information collected from athletes who sustain a concussion during organized sports.
- Secondary Outcome Measures
Name Time Method Advanced Neuroimaging in concussion 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP Exploration of changes in functional neuroimaging which occur with concussion and change in these measures over time.
Trial Locations
- Locations (11)
University of Texas - Austin
🇺🇸Austin, Texas, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
University of South Carolina
🇺🇸Columbia, South Carolina, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
University of Arkansas
🇺🇸Fayetteville, Arkansas, United States
University of Connecticut
🇺🇸Storrs, Connecticut, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of South Florida
🇺🇸Tampa, Florida, United States