Diagnosis of mTBI in a Community Setting

Launched by UNIVERSITY OF MIAMI · May 16, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new portable goggle system called I-PAS, which is designed to help diagnose mild traumatic brain injuries (mTBI) in emergency settings, like urgent care or emergency departments. The researchers want to see if this goggle system can reliably identify mTBI in patients who have had a blow to the head and experienced symptoms such as confusion or loss of consciousness.

To participate, individuals must be between 18 and 50 years old and have recently been treated for a head injury that led to a diagnosis of mTBI. There is also a control group for comparison, which includes people with minor injuries unrelated to the head. Participants will have their condition assessed using the goggle system, and the study aims to gather information to improve how mTBI is diagnosed in the future. It's important to note that certain medical histories, like severe head injuries or specific health conditions, may exclude someone from joining the trial.

Gender

ALL

Eligibility criteria

• 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