Using portable goggles to diagnose mild traumatic brain injury in the community
The Use of a Portable 3D Head Mounted Display (HMD) With Integrated Eye Capture Technology (IPAS Goggles) for the Diagnosis of Mild Traumatic Brain Injury (mTBI) in a Community Setting
This study is testing a new pair of portable goggles to see if they can help doctors diagnose mild traumatic brain injuries more effectively in places like urgent care and emergency rooms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT03539848 on ClinicalTrials.gov |
What this trial studies
This research tests the effectiveness of a portable goggle system called I-PAS for diagnosing mild traumatic brain injury (mTBI) in community settings such as urgent care or emergency departments. The study aims to evaluate the reliability of the I-PAS goggles compared to current diagnostic methods and assess their prognostic value for individuals with mTBI. Participants will include those diagnosed with mTBI and a control group with minor injuries, all recruited from specific medical facilities in Miami.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-50 who have experienced a head injury with symptoms consistent with mTBI.
Not a fit: Patients with a history of significant head injuries or those not presenting with mTBI symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a rapid and reliable diagnostic tool for mild traumatic brain injuries in community settings.
How similar studies have performed: Other studies have explored portable diagnostic tools for brain injuries, but the specific use of the I-PAS system in community settings is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Miami, Florida
- University of Miami Miller School of Medicine — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Michael Hoffer, MD — University of Miami
- Study coordinator: Erin Williams
- Email: ecw44@med.miami.edu
- Phone: 305-243-8959
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.