A Highly Portable Device for Assessment of Mild Traumatic Brain Injury in Deployed and Far-Forward Settings

NCT ID: NCT05527041

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 1600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-09-26

Brief 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. 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Concussed

Subjects age 17-34 years within 72 hours of injury.

EyeBOX Lens (EBLens)

Intervention Type: 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

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.

EyeBOX Lens (EBLens)

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Congressionally Directed Medical Research Programs

FED

Sponsor Role: collaborator

Oculogica, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Cameron, PhD

Role: PRINCIPAL_INVESTIGATOR

Keller Army Community Hospital

Christina Master, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Sadie Buboltz-Dubs, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin - Green Bay

Locations

Keller Army Hospital

West Point, New York, United States

Countries

United States

Other Identifiers

W81XWH21C0103

Identifier Type: -

Identifier Source: org_study_id