Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The purpose of this research study is to test whether a portable goggle system (I-PAS) is
good at diagnosing mild traumatic brain injury (mTBI) in a community setting. The goal is to
determine whether the IPAS goggle system can be used reliably in an urgent care or emergency
department setting.
Phase
N/A
Funding Agency/Sponsor
Other
Disease
Other
Enrollment Eligibility
Participants must meet one of the following inclusion criteria:
1. Males and females from 18-50 years of age who present to the emergency department or
urgent/acute care facility at the University of Miami Hospital, Jackson Memorial
Hospital, or by direct referral to the clinic with a history of all of the following:
1) Blow or impact to head, 2) Period of loss or alteration of consciousness, 3)
Neurosensory symptoms, and 4) Diagnosis by Emergency Room Staff or Medical Staff of
having suffered an mTBI/Concussion.
2. An age- and sex- matched control group also recruited from emergency department or
urgent/acute care facility at the University of Miami Hospital, Jackson Memorial
Hospital, or by direct referral to the clinic. These will include individuals with
minor injuries (e.g ankle sprains, minor knee injuries, etc.) not involving the head
and not requiring admission to the hospital.
Exclusion Criteria:
1. History of head injury characterized by any of the following:
1. Resulting from penetrating trauma
2. Resulting from an automobile accident with significant associated injuries
3. Associated with a Glasgow Comma Scale Score of less than 13 at the time of injury
4. Associated with a loss of consciousness period greater than 59 minutes
5. Judged to be more than mild by Medical Staff
6. Requiring admission to the hospital for any reason
7. Associated with subdural or epidural hemorrhage
2. Head injury history
1. For control group - history of head injury within the last six months or
currently experience any head injury symptoms at time of enrollment
2. For head injured group - history of head injury within the last three months or
experiencing head injury symptoms immediately prior to the current head injury
3. Presence of severe aphasia
4. History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major
depression, schizophrenia)
5. Documented neurodegenerative disorders
6. Pregnancy [Female candidates will be asked if they are pregnant]
7. Prior disorders of hearing and balance including:
1. Meniere's disease
2. Multiple sclerosis
3. Vestibular neuritis
4. Vestibular schwannoma
5. Sudden sensorineural hearing loss
8. History of Cerebrovascular disorders
9. History of ear operation other than myringotomy and tube placement in the past
10. Systemic disorders to include chronic renal failure, cirrhosis of the liver,
autoimmune disease, heart disease, lung disease, or severe arthritis
11. Children
12. Individuals who cannot provide informed consent