Clinical trial NCT03539848: Diagnosis of mTBI in a Community Setting
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Mild Traumatic Brain Injury
Brain Injuries
Brain Injuries, Traumatic
Head Injury
Keywords: TBI
Community Setting
Mild TBI
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Neurolign
First posted: 2018-05-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Number of participants with mTBI
timeFrame: 33 months
Secondary outcomes:
measure: Time to recover
timeFrame: 33 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Michael Hoffer, MD
role: PRINCIPAL_INVESTIGATOR
References: