Diagnosis of mTBI in a Community Setting

University of Miami

Status: Completed

Conditions: Brain Injuries; Head Injury; Traumatic Brain Injury; Brain Injuries, Traumatic; Mild Traumatic Brain Injury

Treatments: Device: I-PAS Goggles

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03539848

20180012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Subjects with mTBI

Experimental group

Description:

Individuals who come to the emergency department or urgent/acute care facility with an mTBI will undergo testing with the I-PAS Goggles.

Treatment:

Device: I-PAS Goggles

Subjects with minor injuries

Active Comparator group

Description:

Individuals who come to the emergency department or urgent/acute care facility with minor injuries (such as ankle sprains or knee sprains) will undergo testing with the I-PAS Goggles.

Treatment:

Device: I-PAS Goggles