Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)

The primary objective of this study is to collect un-blinded BrainPulse recordings from youth
and adults that have a confirmed diagnosis of concussion per protocol guidelines in order to
improve a concussion detection algorithm previously developed by Jan Medical, Inc. In order
to gather sufficient variability, subjects with both confirmed concussion and suspected
concussion will be included in the study as long as they meet eligibility criteria.
BrainPulse recordings from subjects with suspected concussion will be compared to the
recordings of subjects diagnosed with concussion. Subjects will be followed for 21 days after
the initial injury with BrainPulse recordings to study the subject's recovery process. The
symptomatic evaluation, physical examination, and BrainPulse recordings will be entered in a
database to assess clinical outcome and device utilization.

Inclusion Criteria:

1. Age >= 5 years old

2. Suspected or confirmed concussion by medical professional

3. Not more than 3 days since injury/trauma event

4. Willing and able to participate in all required study evaluations and allow access to
medical testing and records

5. Signed informed consent/assent, and/or have a legally authorized representative
willing to provide informed consent on behalf of the subject

6. Demonstrates a minimum of 3 of the following symptoms:

- Headache

- Pressure in head

- Dizziness

- Neck pain

- Fatigue/ low energy

- Nausea or vomiting

- Irritability

- Difficulty in concentrating/performing tasks

- Memory impairment

- Insomnia

- Reduced tolerance to stress

- Sensitivity to light

- Difficulty balancing

- Blurred vision

- Confusion

- More emotional than usual

- Sadness

- Nervous/Anxious

- Vacant stare

- Delayed verbal/motor response

- 'Feeling like in a fog'

- 'Don't feel right'

Exclusion Criteria:

1. Wound or open laceration on the head in the area of one of the BrainPulse sensors that
would impede use of the BrainPulse device

2. Any serious medical condition that in the opinion of the medical professional would
impair ability to provide informed consent/assent or otherwise disqualify a patient
from participation

3. Currently participating in or planning to participate in another clinical study during
the course of the current clinical study

4. Implantation of any medical device in head (e.g. ventriculoperitoneal shunt)