Traumatic Brain Injury
Conditions
Keywords
Traumatic Brain Injury, Eye movement recording
Brief summary
The study investigates whether the use of eye movement recordings can provide a reliable diagnostic of previously undiagnosed mild traumatic brain injury (blast and impact) in Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans.
Detailed description
Eye movements are recorded for Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans with mild traumatic brain injury (mTBI) and compared to the eye movements of those without mTBI. By analyzing and characterizing the differences between the two groups, a diagnostic measure of mTBI through the use of eye movements can be developed.
Interventions
None listed
Sponsors
VA Office of Research and Development
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* OIF/OEF Veteran; * Neuropsych diagnosis of MTBI
Exclusion criteria
* chronically abusing alcohol or illicit drugs. * uncorrected vision prevents subject from effectively viewing the stimuli, unless they can wear contact lenses during the recording session. * inability to make normal eye movements (i.e.: saccades, smooth pursuit) required by study paradigms. Note: Deficit can be caused by taking medications that can potentially affect eye movements or any neurological condition that can interfere with making normal eye movement. * psychological or psychiatric conditions that preclude sustained concentration or ability to perform the tasks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stability of Fixation | During eye movement recording session (20 sec). | The ability to keep eye position fixed on a visual target, measured by the distance between the target and eye fixation point averaged over 20 sec. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Controls Control Group - subjects with no Mild Traumatic Brain Injury (MTBI) | 15 |
| MTBI MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI) | 11 |
| Total | 26 |
Baseline characteristics
| Characteristic | Controls | MTBI | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 11 Participants | 26 Participants |
| Sex: Female, Male Female | 8 Participants | 2 Participants | 10 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 11 |
| serious Total, serious adverse events | 0 / 15 | 0 / 11 |
Outcome results
Primary
Stability of Fixation
The ability to keep eye position fixed on a visual target, measured by the distance between the target and eye fixation point averaged over 20 sec.
Time frame: During eye movement recording session (20 sec).
Population: Although there were 15 participants in the Control arm, data were only analyzed for a cohort of 11 that were age-matched to the MTBI arm participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Controls | Stability of Fixation | 0.8 degrees | Standard Deviation 0.01 |
| MTBI | Stability of Fixation | 1.1 degrees | Standard Deviation 0.1 |