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OpenTrials
Completed

NCT Number: NCT03539848

Diagnosis of mTBI in a Community Setting

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Participants must meet one of the following inclusion criteria:

  • 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.
  • 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

  • History of head injury characterized by any of the following:
  • Resulting from penetrating trauma
  • Resulting from an automobile accident with significant associated injuries
  • Associated with a Glasgow Comma Scale Score of less than 13 at the time of injury
  • Associated with a loss of consciousness period greater than 59 minutes
  • Judged to be more than mild by Medical Staff
  • Requiring admission to the hospital for any reason
  • Associated with subdural or epidural hemorrhage
  • Head injury history
  • For control group - history of head injury within the last six months or currently experience any head injury symptoms at time of enrollment
  • 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
  • Presence of severe aphasia
  • History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia)
  • Documented neurodegenerative disorders
  • Pregnancy [Female candidates will be asked if they are pregnant]
  • Prior disorders of hearing and balance including:
  • Meniere's disease
  • Multiple sclerosis
  • Vestibular neuritis
  • Vestibular schwannoma
  • Sudden sensorineural hearing loss
  • History of Cerebrovascular disorders
  • History of ear operation other than myringotomy and tube placement in the past
  • Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis
  • Children
  • Individuals who cannot provide informed consent

Treatment and study plan

I-PAS Goggles

Device

Portable, head-mounted display goggle system with integrated eye capture technology

Primary outcomes

  1. Number of participants with mTBI

    Time frame: 33 months

    How many participants were detected to have mTBI following an injury.

Secondary outcomes

  1. Time to recover

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Neurolign

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
May 29, 2018
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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