CompletedNot Applicable

Diagnosis of mTBI in a Community Setting

United States120 participantsStarted 2018-08-01

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

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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

What they're measuring

Number of participants with mTBI

Timeframe: 33 months

Trial details

NCT IDNCT03539848

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Traumatic Brain Injury trials