Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
The multi-center study evaluates BrainPulse recordings from subjects with a suspected or
 confirmed concussion to improve a concussion detection algorithm. Subjects may also consent
 for a 5 additional follow-ups over a 21-day period to compare the progression of change in
 their BrainPulse recordings.
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)