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| Name | Class |
|---|---|
| Neurolign | INDUSTRY |
| Sync-Think, Inc. | INDUSTRY |
| Oculogica, Inc. | INDUSTRY |
| TBICoE |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TBI Group | Other | Subjects with history of TBI will undergo testing with all three devices. |
|
| Control Group | Other | Subjects with no history of TBI will undergo testing with all three devices. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuro Kinetics IPAS | Device | Testing with PAS device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) | Determination of sensitivity/specificity measure for each device using known characteristics of arms (i.e., history of TBI vs no history of TBI) | Single test session (1.5 hours) - all testing performed at time of study enrollment, will be reported at conclusion of data collection as all data is required to generate AUCs. |
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All participants must be DEERS eligible, no exceptions!
Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Louis French, PsyD | NICoE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Intrepid Center of Excellence | Bethesda | Maryland | 20889 | United States |
IPD will not be shared. All data from project will be shared in de-identified format as group data, not IPD.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 23, 2023 | Sep 15, 2023 | 4 | ||
| Jan 30, 2024 |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| United States Department of Defense | FED |
All participants undergo testing with the same three devices. The order of devices will be semi-randomized to eliminate order effects.
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| Oculogica EyeBox |
| Device |
Testing with Oculogica EyeBox device |
|
| SyncThink EyeSync Device | Device | Testing with SyncThink EyeSync device |
|
| Feb 27, 2024 |
| 5 |
| Mar 15, 2024 | Apr 9, 2024 | 6 |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |