An Evaluation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Patients After Concussion

Concussion diagnosis and assessment suffers from lack of a gold-standard measurement,
leaving physicians to rely on physical and neurological examinations, neurocognitive/mental
status testing, and balance examination, which can be time-consuming and influenced by
subjective factors. In order to address this significant drawback, there is a need for novel
modalities that diagnose and monitor concussion in a quick easy-to-use and non-invasive
manner.

Based on our previous analysis of the physiological processes using acoustic signals that
were collected and analyzed so far, our hypothesis is that the HS-1000 is capable of
diagnosing and monitoring concussed patients, based on the acoustic raw data derived from
the generated acoustic signal along with the analysis of the acoustic signals that derive
from the physiological processes in the brain. These processes, e.g. cerebral blood-flow and
the respiratory cycle, are impaired during changes in intracranial pressure (ICP) and are
hypothesized to change as well once the patient is concussed.

Concussed athletes will be identified through routine visits at the Vanderbilt Sports
Concussion Center. Controls will be identified among non-concussed athletes being seen at
Vanderbilt Sports Medicine and will be offered participation.

After signing informed consent, both healthy subjects and patients will undergo screening
assessments for this study. Eligible patients and healthy subjects will be enrolled into the
study and HS-1000 headset portion of the device will be placed in their ears. HS-1000
monitoring intervals will last from 20 minutes continuously. Following completion of data
collection, HS-1000 will be removed.

Safety evaluation will include monitoring of adverse events throughout the study.

The study duration for each patient will be up to 1 hour. Healthy subjects will undergo two
recordings approximately two weeks apart.

Post-concussion patients will have multiple sessions:

- Session #1 Baseline recording as soon as possible

- Session #2 48 hours after session #1

- Session #3 1 week after session #1

- Session #4 1 month after session #1

Inclusion Criteria:

- Healthy subjects with no previous concussions:

1. Male or female subjects, aged 13 - 25 years old at screening visit

2. Subjects who were previously diagnosed by standard methods as healthy subjects
with no previous concussions

3. Subject is able and willing to comply with the requirements of the protocol

4. Subject is able to understand and sign written informed consent to participate
in the study

- Post-concussion diagnosed patients:

1. Male or female subjects, aged 13-25 years at screening visit

2. Subjects who were previously diagnosed by standard methods as suffering from
concussion

3. Subject is able and willing to comply with the requirements of the protocol

4. Subject is able to understand and sign written informed consent to participate
in the study

Exclusion Criteria:

1. Local ear infection

2. Known allergy or hypersensitivity to any of the test materials or contraindication to
test materials

3. Subjects currently enrolled in or less than 30 days post-participation in other
investigational device or drug study(s), or receiving other investigational agent(s)

4. Any condition that may jeopardize study participation (e.g., abnormal clinical or
laboratory finding) or interpretation of study results, or may impede the ability to
obtain informed consent

5. History of psychiatric illness, chemical dependency, Attention-Deficit Hyperactivity
Disorder (ADHD), Learning Disability, seizure disorder, prior neurosurgical
intervention

6. Current use of psychotropic medication