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

Oculogica

Status: Invitation-only

Conditions: Mild Traumatic Brain Injury; Concussion, Brain

Treatments: Device: EyeBOX Lens (EBLens)

Study type: Observational

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT05527041

W81XWH21C0103

Details and patient eligibility

About

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.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 17 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

CONCUSSED:

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.

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:

Inclusion Criteria:

• 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 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 design

1,600 participants in 2 patient groups

Concussed

Description:

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

Treatment:

Device: EyeBOX Lens (EBLens)

Non-concussed

Description:

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.

Treatment:

Device: EyeBOX Lens (EBLens)