Brain Injuries, Traumatic, Concussion, Brain, Concussion, Intermediate, Concussion, Mild, Concussion, Severe
Conditions
Keywords
Concussion, Mild Traumatic Brain Injury, Sport Related Concussion
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.
Interventions
DEVICEBrainScope Ahead 200iD
The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and a balance/sway measurement. BrainScope Ahead 200iD device will be used to perform EEG.
Diffusion tensor imaging (DTI) is a magnetic resonance imaging technique that enables the measurement of the restricted diffusion of water in tissue in order to produce neural tract images instead of using this data solely for the purpose of assigning contrast or colors to pixels in a cross sectional image.
Sponsors
United States Department of Defense
BrainScope Company, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* 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. 1. If loss of consciousness, total duration less than \<20 minutes 2. No evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment) 3. No hospital admission due to either head injury or collateral injuries for \>24 hours. 4. GCS is between 13-15.
Exclusion criteria
1. Evidence of illicit drug usage 2. Do not speak or read English 3. Current CNS active prescription medications, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD) 4. Skull abnormalities, e.g. metal plate 5. History of brain surgery or neurological disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed