Oculomotor Assessment of Traumatic Brain Injury (TBI)
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 5/17/2017 |
| Start Date: | June 2017 |
| End Date: | June 2019 |
| Contact: | John King, Ph.D. |
| Email: | john.e.king328.civ@mail.mil |
| Phone: | 301-204-0277 |
The purpose of the proposed study is to compare the sensitivity and specificity of three
oculomotor test devices in normal subjects versus subjects with history of TBI. The study is
designed as a prospective research project in which a group of 120 normal controls without a
history of TBI will be compared to another group of 120 participants (total of 240) who have
a confirmed history of TBI. Each participant will complete the TBI assessment protocol for
each of three separate devices (Neuro Kinetics, SyncThink, and Oculogica). The order of the
devices will be counter-balanced across participants. Participants will also be screened for
vestibular migraine and visual vertigo, which are two conditions that influence
oculo-vestibular perception in normal and TBI patients and might influence the results from
the three oculomotor devices. Data from each device will be utilized to perform AUC analyses
to determine the respective sensitivity and specificity for each.
oculomotor test devices in normal subjects versus subjects with history of TBI. The study is
designed as a prospective research project in which a group of 120 normal controls without a
history of TBI will be compared to another group of 120 participants (total of 240) who have
a confirmed history of TBI. Each participant will complete the TBI assessment protocol for
each of three separate devices (Neuro Kinetics, SyncThink, and Oculogica). The order of the
devices will be counter-balanced across participants. Participants will also be screened for
vestibular migraine and visual vertigo, which are two conditions that influence
oculo-vestibular perception in normal and TBI patients and might influence the results from
the three oculomotor devices. Data from each device will be utilized to perform AUC analyses
to determine the respective sensitivity and specificity for each.
Inclusion Criteria:
- Must be between 18 and 45 at time of screening (upper age restriction is to prevent
confounding with age-related physiological changes).
- Must be able to provide written informed consent.
- Must be able to read and understand questionnaires and consent forms.
- Must have corrected binocular acuity of at least 20/40 for near distance with or
without single-power corrective lenses or contacts and absent of ocular injury or
disease.
Control Group - No history of TBI or any history of severe or penetrating TBI
TBI Group - Must have a documented history of a TBI occurring within the last 10 years.
Exclusion Criteria:
- Current or previous neurological disease, including: stroke, congenital brain
malformation, degenerative illness such as multiple sclerosis, epilepsy or seizure
(other than febrile seizure).
- Current or previous ocular disease/injury, including: Glaucoma or increased pressure
in the eyes, structural damage to ocular tract and ocular cortex, etc.
- History of vestibular disorder (e.g., with symptoms of clinical vertigo)
- Binocular vision not correctable to 20/40 for near distance
- Use of tobacco or caffeinated products less than four hours before test session
- Consumption of alcohol within past 24 hours
We found this trial at
1
site
8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
Phone: 301-204-0277
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