Validation of Brain Function Assessment Algorithm for mTBI/Concussion
Validation of Brain Function Assessment Algorithm for mTBI/Concussion
This study is Part 2 of data collection from 13-25 years old subject population for
 validation of previously derived algorithms. This data will be combined with that collected
 under NCT02957461 (Part 1 with subject age range 18-25 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 NCT02957461 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.
Inclusion Criteria:

 For Injured subjects:

 1. Having sustained a traumatic closed head injury within 72 hours (3 days) from time of
 injury at time of BrainScope assessment;

 2. GCS 13-15 at time of BrainScope assessment;

 3. No hospital admission due to either head injury or collateral injuries for >24 hours.

 For Matched Controls:

 1. GCS 15 at time of BrainScope assessment;

 2. No prior history of concussion or TBI in the last year.

 Exclusion Criteria:

 1. Previously enrolled in the BrainScope CAS Studies;

 2. Current CNS active prescription medications taken daily, with the exception of
 medications being taken for the treatment of Attention Deficit Disorder (ADD) or
 Attention Deficit Hyperactivity Disorder (ADHD);

 3. Forehead, scalp or skull abnormalities that prevents headset application or EEG data
 collection;

 4. History of brain surgery or neurological disease;

 5. Pregnant women;

 6. Subjects who do not speak English (non-English speaking parents are allowed to consent
 so long as translation of the consent form in their native language is available);

 7. Acute intoxication;

 8. Evidence of illicit drug usage;

 For Injured subjects:

 1. Loss of consciousness ≥ 20 minutes related to the concussion injury;

 2. Active fever defined as greater than 100ºF or 37.78ºC at time of BrainScope
 assessment;

 3. Evidence of abnormality visible on Computerized Tomography (CT) of the head related to
 the traumatic event (Note: neuroimaging is not required for enrollment).

 For Matched Controls:

 1. Any focal neurological signs including aphasia, apraxia, diplopia, facial droop,
 dysarthria/slurred speech;

 2. History of Motor Vehicle Accident (MVA) requiring an Emergency Department visit within
 the past 1 year.