COMPLETED

Diagnosis of mTBI in a Community Setting

Conditions

Traumatic Brain Injury Mild Traumatic Brain Injury Brain Injuries Brain Injuries, Traumatic Head Injury TBI Community Setting Mild TBI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2018-08-01

Study Completion:2025-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03539848

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Principal Investigator

Michael Hoffer, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami Miller School of Medicine

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Michael Hoffer, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-01

Study Completion Date2025-04-30

Study Record Updates

Study Start Date2018-08-01

Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

TBI
Community Setting
Mild TBI

Additional Relevant MeSH Terms

Traumatic Brain Injury
Mild Traumatic Brain Injury
Brain Injuries
Brain Injuries, Traumatic
Head Injury