Traumatic Brain InjuryNCT03156010
Oculomotor Assessment of Traumatic Brain Injury (TBI)
A study testing Neuro Kinetics IPAS, Oculogica EyeBox and SyncThink EyeSync Device in people with Traumatic Brain Injury, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Neuro Kinetics IPAS, Oculogica EyeBox and SyncThink EyeSync Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2017to 19 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Intrepid Center of Excellence
Bethesda, Maryland, 20889
About this study
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Neuro Kinetics IPAS, Oculogica EyeBox, SyncThink EyeSync Device
- Keywords
- oculomotor testing
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro Kinetics IPASDevice
Testing with PAS device
Oculogica EyeBoxDevice
Testing with Oculogica EyeBox device
SyncThink EyeSync DeviceDevice
Testing with SyncThink EyeSync device
| Study group | Role | What they receive |
|---|---|---|
| TBI Group | Other | Subjects with history of TBI will undergo testing with all three devices. Receives: Device: Neuro Kinetics IPAS; Device: Oculogica EyeBox; Device: SyncThink EyeSync Device |
| Control Group | Other | Subjects with no history of TBI will undergo testing with all three devices. Receives: Device: Neuro Kinetics IPAS; Device: Oculogica EyeBox; Device: SyncThink EyeSync Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start18 Sep 2017
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants undergo testing with the same three devices. The order of devices will be semi-randomized to eliminate order effects.
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Neurolign, Sync-Think, Inc., Oculogica, Inc., TBICoE, United States Department of Defense
- Responsible party
- Principal investigator, Dr. John King, Walter Reed National Military Medical Center
- Investigators
- Louis French, PsyD, Principal investigator, NICoE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156010
- Sponsor's protocol ID
- WRNMMC-2017-0045
- Status last verified
- Aug 2023
- First submitted
- 11 May 2017
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared. All data from project will be shared in de-identified format as group data, not IPD.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oculomotor Assessment of Traumatic Brain Injury (TBI)
- ClinicalTrials.gov ID
- NCT03156010
- Acronym / sponsor ID
- WRNMMC-2017-0045
- Conditions
- Traumatic Brain Injury
- Keywords
- oculomotor testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- Neurolign, Sync-Think, Inc., Oculogica, Inc., TBICoE, United States Department of Defense
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants undergo testing with the same three devices. The order of devices will be semi-randomized to eliminate order effects.
| Arm | Type | Receives |
|---|---|---|
| TBI Group | Other | Device: Neuro Kinetics IPAS, Device: Oculogica EyeBox, Device: SyncThink EyeSync DeviceSubjects with history of TBI will undergo testing with all three devices. |
| Control Group | Other | Device: Neuro Kinetics IPAS, Device: Oculogica EyeBox, Device: SyncThink EyeSync DeviceSubjects with no history of TBI will undergo testing with all three devices. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuro Kinetics IPASTesting with PAS device | Device | Control Group, TBI Group |
| Oculogica EyeBoxTesting with Oculogica EyeBox device | Device | Control Group, TBI Group |
| SyncThink EyeSync DeviceTesting with SyncThink EyeSync device | Device | Control Group, TBI Group |
Primary outcome
Area Under the Curve (AUC)
Time frame: 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.
Determination of sensitivity/specificity measure for each device using known characteristics of arms (i.e., history of TBI vs no history of TBI)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis French, PsyD principal investigator
NICoE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro Kinetics IPAS, Oculogica EyeBox and SyncThink EyeSync Device in people with Traumatic Brain Injury, run by Walter Reed National Military Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (AUC) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.