Last updated on February 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Mild Traumatic Brain Injury
  • Age: Between 13 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Age > 13 years old and not part of any other vulnerable population such as pregnant women.
  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)
  5. An alternative diagnosis is made other than concussion

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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