Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment, Young Adults and Adults

Mild traumatic brain injury, also known as concussion, occurs commonly in sport. The Centers
for Disease Control and Prevention estimate that as many as 3.8 million sport-related
concussions occur annually in the United States. Although many concussions resolve completely
and spontaneously, almost 1 in 4 patients will go on to experience post-concussion syndrome
(PCS). In the United States, PCS diagnoses have increased 100% from 2010-2015. Concurrently,
recent advances in EEG evoked response potential analysis have led to a novel technique for
assessing brain network activation (BNA) patterns. The purpose of this study is to explore
the use of BNA in individuals who are diagnosed with PCS or have the risk of experiencing PCS
due to a recent injury.

ElMindA, the sponsor of this study, has developed a novel method to automatically reveal
functional networks of brain activity based on analysis of EEG Event Related Potential (ERP)
data. This technological platform is capable of providing new metrics of brain function which
can assist in patient evaluation and management. The analysis is done in two separate
processes which are entirely separate and are performed independently of one another. First
EEG data are recorded and analyzed from a group, or several groups, of subjects to establish
a set of group patterns which characterized the brain network activity of the group. Second,
EEG data from a single subject are processed to enable subject evaluation, as compared to the
established group patterns. This individual analysis is the basis of the BNA scores computed
for an individual subject.

Primary Objective:

• Exploratory (e.g. Hypothesis-generating) study designed to collect data that will aid in
future understanding of the relationship between Post Concussion Syndrome and
Electrophysiology. The results are primarily intended for scientific inquiry and development
purposes.

Additional objectives:

- Exploring the relationship between the characteristics of early/acute stage Mild
Traumatic Brain Injury and the subsequent development of PCS

- Collecting electrophysiological and clinical data that will serve as the basis for
athlete brain health case studies.

Arm 1: Study staff will contact subjects tested in the past with BNA and were diagnosed with
Post-Concussion Syndrome at their medical facility.

Arm 2: Eligible subjects treated at the study medical facility for acute concussion or Post
Concussion Syndrome will be approached by the study staff.

Interested volunteers will complete a brief initial in person or phone consultation with a
member of the study team and those who meet eligibility criteria and wish to participate will
be invited for a study visit in the testing facility. During this visit, a member of the
study team will describe the study in greater detail, verify subject eligibility, obtain
informed written consent/assent for study participation, and record relevant demographic,
medical history information, concussion history and clinical assessment questioners as
provided by the subject or as available from subject's medical records. The subject will then
have the EEG electrode cap placed on their head and will undergo the BNA test after a brief
training and instructional session.

Inclusion Criteria:

- Males and females Aged 12-50

- Willingness to participate in the study and the ability to give informed assent (for
children) and/or consent (for the parent of a minor or adults aged 18 years of age or
older for themselves).

- Subjects that are or were diagnosed with mTBI according to the standard diagnostic
procedures at the investigational site in a timeframe that meets enrollment criteria.

- Subjects that are experiencing symptoms of concussion or Post-concussion Syndrome at
the time of their initial test session.

Exclusion Criteria:

- Subjects that have undergone neuroimaging with identification of intracranial
structural pathology.

- Self-reported history of central nervous system injury other than mTBI, or disease
(examples will include, but will not be limited to, moderate or severe traumatic brain
injury (TBI with a Glasgow Coma Scale < 13) epilepsy, seizures, brain surgery)

- Neuropsychological disorder such as autistic spectrum disorder

- Any history of a learning disability (examples include, but will not be limited to,
dyslexia, dysgraphia, dyscalculia, or a nonverbal learning disorder)

- Use of any medication affecting central nervous system (CNS) in the past 3 months
prior to their BNA (i.e. antidepressants, anticonvulsants, psychostimulants, first
generation antihistamines, etc.)

- Active head lice infection

- Open scalp wound

- baldness, dread locks or hair that is otherwise sufficiently long and thick so as to
preclude appropriate scalp electrode cap fit

- Deafness, and/or blindness