Diagnosis of mTBI in a Community Setting

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.

Conditions

Traumatic Brain Injury, Mild Traumatic Brain Injury, Brain Injuries, Brain Injuries, Traumatic, Head Injury

Study Overview

Study Details

Study overview

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 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

Diagnosis of mTBI in a Community Setting

Condition
Traumatic Brain Injury
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami Miller School of Medicine, Miami, Florida, United States, 33136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Miami,

Michael Hoffer, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

2026-09-30