Objective Brain Function Assessment of mTBI From Initial Injury to Rehabilitation and Treatment Optimization in College Athletes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Injuries, Traumatic
- Sponsor
- BrainScope Company, Inc.
- Enrollment
- 520
- Locations
- 11
- Primary Endpoint
- Algorithm for Likelihood of being concussed
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Algorithm for Likelihood of being concussed
Time Frame: 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 Outcomes
- Advanced Neuroimaging in concussion(6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP)