Brain Injuries, Brain Injuries, Traumatic, Head Injury, Mild Traumatic Brain Injury, Traumatic Brain Injury
Conditions
Keywords
TBI, Community Setting, Mild TBI
Brief 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.
Detailed description
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. The study further looks at current metrics and compares their efficacy in both the diagnosis and prognostic value of individuals with mTBI.
Interventions
DEVICEI-PAS Goggles
Portable, head-mounted display goggle system with integrated eye capture technology
Sponsors
Neurolign
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with mTBI | 33 months | How many participants were detected to have mTBI following an injury. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to recover | 33 months | Measuring the time (days) it takes for readiness to return to normal activity after a head injury for participants with a detected mTBI |
Countries
United States
Outcome results
None listed