Concussion, BrainNCT05527041
A Highly Portable Device for Assessment of Mild Traumatic Brain Injury in Deployed and Far-Forward Settings
An observational study of Concussion, Brain and Mild Traumatic Brain Injury, run by Oculogica, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to develop a highly portable, ruggedized diagnostic tool for concussion, EyeBOX Lens (EBLens), that can be utilized in deployed field and far-forward settings. Read more about this study
- Who is it for?
- Ages 17 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Brain, Mild Traumatic Brain Injury
- What is being tested?
- EyeBOX Lens (EBLens)
- Type of treatment
- Medical device
- How many people
- 1,600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 26 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 17 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants will be young athletes or cadets between the ages of 18-35. Cadets at the USMA who are 17 and are emancipated will also be included. To be included in the algorithm development study, subjects must either be uninjured (to fall into the uninjured cohort) or have experienced a concussive event (to fall into the injured cohort). In the validation study, subjects must be participants who have completed baseline testing and have consented to participate.
Who may be able to join
- Provide documented informed consent.
- Have presented, at any time post injury, for any complaint related to an injury involving either a direct force to the head or a blow to the body that has the potential to transmit a rapid acceleration/deceleration of the head, with or without loss of consciousness, with or without external signs of head injury.
- Be a current cadet/enrolled student age 17-34.
- Have the ability to provide a complete ophthalmologic, medical, and neurologic history as well as report current medications.
- Provide documented informed consent.
- Be a current cadet/enrolled student age 17-34.
- Have the ability to provide a complete ophthalmologic, medical, and neurologic history as well as report current medications.
Who cannot join
- Have penetrating trauma or known skull fracture or intracranial injury.
- Have had a conventional head CT or MRI demonstrating evidence of structural brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read).
- Be blind (no light perception), have missing or non-functional eyes.
- Be unable to open their eyes.
- Have a history of unresolved strabismus, diplopia, amblyopia.
- Have a history of unresolved cranial nerve III, IV, or VI palsy.
Show all 22Show fewer
- Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
- Have a history of extensive prior eye surgery or scarring (examples include strabismus surgery, scleral buckle repair of retinal detachment, repair of blow out fractures of the orbit and any procedures that would interfere with extraocular muscle movements; prior cataract surgery or Lasik are not exclusions).
- Have a prior history of unresolved ocular-motor dysfunctions.
- Be intoxicated.
- CONTROLS:
- Have presented, within the prior six months, for any complaint related to an injury involving either a direct force to the head or a blow to the body that has the potential to transmit a rapid acceleration/deceleration of the head, with or without loss of consciousness, with or without external signs of head injury.
- Have penetrating trauma or known skull fracture or intracranial injury.
- Have had a conventional head CT or MRI demonstrating evidence of structural brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read).
- Be blind (no light perception), have missing or non-functional eyes.
- Be unable to open their eyes.
- Have a history of unresolved strabismus, diplopia, amblyopia.
- Have a history of unresolved cranial nerve III, IV, or VI palsy.
- Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
- Have a history of extensive prior eye surgery or scarring (examples include strabismus surgery, scleral buckle repair of retinal detachment, repair of blow out fractures of the orbit and any procedures that would interfere with extraocular muscle movements; prior cataract surgery or Lasik are not exclusions).
- Have a prior history of unresolved ocular-motor dysfunctions.
- Be intoxicated.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to develop a highly portable, ruggedized diagnostic tool for concussion, EyeBOX Lens (EBLens), that can be utilized in deployed field and far-forward settings. The EBLens will be based on a concussion diagnostic algorithm from the FDA cleared EyeBOX device, developed by Oculogica, and eye-tracking data collected from a wearable set of eye-tracking glasses, developed by Adhawk Microsystems. Once the EBLens is prototyped, an algorithm for diagnosing concussion will be developed that is specifically appropriate for the EBLens via a case-control clinical study comparing 100 concussed to 100 non-concussed subjects (Phase I). Participants, age 18-35 years, will be recruited from the KACH research team and affiliated providers and clinical sites. Concussed individuals will be assessed within 72 hours of concussion. Demographics, basic medical history, symptom severity, a visio-vestibular exam and the EBLens scan will be collected on both injured cases and uninjured controls at a single time point.
The algorithm and the EBLens will be validated in a subsequent, prospective cohort validation study (Phase II) designed for FDA submission. The correlation of the EBLens output with resolution of symptoms will also be observed in longitudinal follow-up of concussed participants in the validation study. The participant population for this study will be cadets recruited from the USMA and young athletes recruited from affiliated sites during baseline concussion testing. Participants will be assessed at baseline at the start of their academic year or sports season. Those participants who experience a concussive injury will be assessed again at three time points; 1) within 72 hours of injury, 2) weekly until and at the time of initiation of a graded return to activity protocol, and 3) upon clearance for unrestricted RTP/RTD.
- Conditions
- Concussion, Brain, Mild Traumatic Brain Injury
- Being tested
- EyeBOX Lens (EBLens)
- Keywords
- Traumatic Brain Injury, Eye-tracking, Far-forward Settings, Return-to-Activity, Diagnostic
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyeBOX Lens (EBLens)Device
The investigational device, EBLens, consists of eye-tracking scanners and sensors, developed by AdHawk Microsystems, embedded into a rugged pair of eye-glasses. The subject will wear the EBLens form factor while seated about 40 cm from a small handheld computer screen. The subject will be instructed to watch a video on the screen, while trying not to move their head. The operator will then initiate the EBLens test sequence. During this test a video will be displayed on only a portion of the screen (aperture about 1/9 the size of the screen) for 90 seconds. The video aperture will begin in the upper left corner, and, after 10 seconds, moves in a clockwise direction around the screen for 2 cycles, each taking 40 seconds. During the scan, the following data are collected at a frame rate from 100 to 500 Hz:
- Gaze coordinates
- Pupil sizes
- Accelerometer data
- Gyroscopic data
- Rotation data
- Blink data
| Study group | Role | What they receive |
|---|---|---|
| Concussed | Subjects age 17-34 years within 72 hours of injury. Receives: Device: EyeBOX Lens (EBLens) | |
| Non-concussed | In Phase I, uninjured, matched controls. In Phase II, subjects completing baseline concussion testing as part of the standard of care or athletics pre-season. Receives: Device: EyeBOX Lens (EBLens) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of acute clinical diagnosis of concussion using EBLens form factor and algorithm
The EBLens will have at least 70% sensitivity and specificity for diagnosis of acute concussion
Measured: Within 72 hours of injury
Secondary outcomes (1)
Diagnostic accuracy of recovery determination for return to activity and duty (RTA / RTD) using EBLens form factor and algorithm
The EBLens will have at least 70% sensitivity and specificity for recovery determination for return to activity and duty (RTA / RTD) without complication.
Measured: Through study completion, up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Jul 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion26 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oculogica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Kenneth Cameron, PhD, Principal investigator, Keller Army Community HospitalChristina Master, MD, Principal investigator, Children's Hospital of PhiladelphiaSadie Buboltz-Dubs, PhD, Principal investigator, University of Wisconsin - Green Bay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527041
- Sponsor's protocol ID
- W81XWH21C0103
- Status last verified
- Mar 2025
- First submitted
- 30 Aug 2022
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Highly Portable Device for Assessment of Mild Traumatic Brain Injury in Deployed and Far-Forward Settings
- ClinicalTrials.gov ID
- NCT05527041
- Acronym / sponsor ID
- W81XWH21C0103
- Conditions
- Concussion, Brain, Mild Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Eye-tracking, Far-forward Settings, Return-to-Activity, Diagnostic
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Oculogica, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 26 Sep 2025 (estimated)
- First posted
- 2 Sep 2022 (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 this study is to develop a highly portable, ruggedized diagnostic tool for concussion, EyeBOX Lens (EBLens), that can be utilized in deployed field and far-forward settings. The EBLens will be based on a concussion diagnostic algorithm from the FDA cleared EyeBOX device, developed by Oculogica, and eye-tracking data collected from a wearable set of eye-tracking glasses, developed by Adhawk Microsystems. Once the EBLens is prototyped, an algorithm for diagnosing concussion will be developed that is specifically appropriate for the EBLens via a case-control clinical study comparing 100 concussed to 100 non-concussed subjects (Phase I). Participants, age 18-35 years, will be recruited from the KACH research team and affiliated providers and clinical sites. Concussed individuals will be assessed within 72 hours of concussion. Demographics, basic medical history, symptom severity, a visio-vestibular exam and the EBLens scan will be collected on both injured cases and uninjured controls at a single time point.
The algorithm and the EBLens will be validated in a subsequent, prospective cohort validation study (Phase II) designed for FDA submission. The correlation of the EBLens output with resolution of symptoms will also be observed in longitudinal follow-up of concussed participants in the validation study. The participant population for this study will be cadets recruited from the USMA and young athletes recruited from affiliated sites during baseline concussion testing. Participants will be assessed at baseline at the start of their academic year or sports season. Those participants who experience a concussive injury will be assessed again at three time points; 1) within 72 hours of injury, 2) weekly until and at the time of initiation of a graded return to activity protocol, and 3) upon clearance for unrestricted RTP/RTD.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concussed | – | Device: EyeBOX Lens (EBLens)Subjects age 17-34 years within 72 hours of injury. |
| Non-concussed | – | Device: EyeBOX Lens (EBLens)In Phase I, uninjured, matched controls. In Phase II, subjects completing baseline concussion testing as part of the standard of care or athletics pre-season. |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants will be young athletes or cadets between the ages of 18-35. Cadets at the USMA who are 17 and are emancipated will also be included. To be included in the algorithm development study, subjects must either be uninjured (to fall into the uninjured cohort) or have experienced a concussive event (to fall into the injured cohort). In the validation study, subjects must be participants who have completed baseline testing and have consented to participate.
Key inclusion criteria (7 listed)
- Provide documented informed consent.
- Have presented, at any time post injury, for any complaint related to an injury involving either a direct force to the head or a blow to the body that has the potential to transmit a rapid acceleration/deceleration of the head, with or without loss of consciousness, with or without external signs of head injury.
- Be a current cadet/enrolled student age 17-34.
- Have the ability to provide a complete ophthalmologic, medical, and neurologic history as well as report current medications.
- Provide documented informed consent.
Key exclusion criteria (22 listed)
- Have penetrating trauma or known skull fracture or intracranial injury.
- Have had a conventional head CT or MRI demonstrating evidence of structural brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read).
- Be blind (no light perception), have missing or non-functional eyes.
- Be unable to open their eyes.
- Have a history of unresolved strabismus, diplopia, amblyopia.
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 |
|---|---|---|
| EyeBOX Lens (EBLens)The investigational device, EBLens, consists of eye-tracking scanners and sensors, developed by AdHawk Microsystems, embedded into a rugged pair of eye-glasses. The subject will wear the EBLens form factor while seated about 40 cm from a small handheld computer screen. The subject will be instructed to watch a video on the screen, while trying not to move their head. The operator will then initiate the EBLens test sequence. During this test a video will be displayed on only a portion of the screen (aperture about 1/9 the size of the screen) for 90 seconds. The video aperture will begin in the upper left corner, and, after 10 seconds, moves in a clockwise direction around the screen for 2 cycles, each taking 40 seconds. During the scan, the following data are collected at a frame rate from 100 to 500 Hz: * Gaze coordinates * Pupil sizes * Accelerometer data * Gyroscopic data * Rotation data * Blink data | Device | Concussed, Non-concussed |
Primary outcome
Diagnostic accuracy of acute clinical diagnosis of concussion using EBLens form factor and algorithm
Time frame: Within 72 hours of injury
The EBLens will have at least 70% sensitivity and specificity for diagnosis of acute concussion
1 secondary outcome
Diagnostic accuracy of recovery determination for return to activity and duty (RTA / RTD) using EBLens form factor and algorithm
Time frame: Through study completion, up to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
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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.
Kenneth Cameron, PhD principal investigator
Keller Army Community Hospital
Christina Master, MD principal investigator
Children's Hospital of Philadelphia
Sadie Buboltz-Dubs, PhD principal investigator
University of Wisconsin - Green Bay
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Brain and Mild Traumatic Brain Injury, run by Oculogica, Inc. 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 7 inclusion and 22 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: enrolling by invitation, as of the sponsor's last update on 31 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Diagnostic accuracy of acute clinical diagnosis of concussion using EBLens form factor and algorithm (time frame: Within 72 hours of injury). 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 31 Jul 2025.