Mild Traumatic Brain Injury
Conditions
Keywords
mTBI, TBI, brain injury, concussion
Brief summary
This study aims to determine the validity and safety of disparity driven vergence using a portable goggle system (I-PAS) using a pseudorandom ternary sequence of frequencies for testing.
Interventions
DEVICEI-PAS Goggles
Portable, head-mounted display goggle system with integrated eye capture technology
Sponsors
University of Miami
Neurolign
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18 to 65 * Both females and males
Exclusion criteria
* Central processing disorder * Impaired vision without corrective lenses (max 20/60 uncorrected) * Moderate to severe hearing loss (\>55 decibels (dB) pure tone audiometry (PTA), \<50% word identification) * Vestibular disorder except for patients recruited for subjects recruited with a history of mild traumatic brain injury to compare to normal participants * History of ear surgery other than myringotomy with or without tube placement * Pregnant women * Prisoners * Adults unable to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pseudorandom Ternary Sequence of Frequency | 15 minutes | Pseudorandom Ternary Sequence of Frequency (reported in Hertz) will be measured via mergence testing using the IPAS goggles. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael Hoffer, MD
University of Miami
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Injured Participants Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles
I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology | 14 |
| Uninjured Participants Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles
I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology | 26 |
| Total | 40 |
Baseline characteristics
| Characteristic | Injured Participants | Uninjured Participants | Total |
|---|---|---|---|
| Age, Continuous | 33.4 years STANDARD_DEVIATION 9.7 | 36.3 years STANDARD_DEVIATION 16.9 | 34.05 years STANDARD_DEVIATION 12.2 |
| Race/Ethnicity, Customized Caucsian Caucasian | 4 Participants | 6 Participants | 10 Participants |
| Race/Ethnicity, Customized Caucsian Hispanic | 8 Participants | 16 Participants | 24 Participants |
| Race/Ethnicity, Customized Caucsian Other | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Female | 8 Participants | 19 Participants | 27 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 26 |
| other Total, other adverse events | 0 / 14 | 0 / 26 |
| serious Total, serious adverse events | 0 / 14 | 0 / 26 |
Outcome results
Primary
Pseudorandom Ternary Sequence of Frequency
Pseudorandom Ternary Sequence of Frequency (reported in Hertz) will be measured via mergence testing using the IPAS goggles.
Time frame: 15 minutes
Population: All participants
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Injured Participants | Pseudorandom Ternary Sequence of Frequency | 0.07 Hertz | Standard Deviation 0.69 |
| Uninjured Participants | Pseudorandom Ternary Sequence of Frequency | 0.1 Hertz | Standard Deviation 0.54 |