Diagnosis of mTBI in a Community Setting

Not Applicable

Recruiting

• Conditions: Brain Injuries; Head Injury; Traumatic Brain Injury; Mild Traumatic Brain Injury; Brain Injuries, Traumatic
• Interventions: Device: I-PAS Goggles

• Registration Number: NCT03539848
• Lead Sponsor: University of Miami

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-16
• Study First Posted: 2018-05-29
• Study Start: 2018-08-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of participants with mTBI	33 months	How many participants were detected to have mTBI following an injury.

Secondary Outcome Measures

Name	Time	Method
Time to recover	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

Trial Locations

Locations (1)

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States