Clinical trial NCT05527041: A Highly Portable Device for Assessment of Mild Traumatic Brain Injury in Deployed and Far-Forward Settings
Official title: A Highly Portable Device for Assessment of Mild Traumatic Brain Injury in Deployed and Far-Forward Settings
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Concussion, Brain
Mild Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Eye-tracking
Far-forward Settings
Return-to-Activity
Diagnostic
Lead sponsor: Oculogica, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Congressionally Directed Medical Research Programs
First posted: 2022-09-02
Enrollment: 1600
Sex: ALL
Minimum age (years): 17
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Diagnostic accuracy of acute clinical diagnosis of concussion using EBLens form factor and algorithm
timeFrame: Within 72 hours of injury
Secondary outcomes:
measure: Diagnostic accuracy of recovery determination for return to activity and duty (RTA / RTD) using EBLens form factor and algorithm
timeFrame: Through study completion, up to one year
Other outcomes:
Locations:
city: West Point
country: United States
facility: Keller Army Hospital
state: New York
Study officials:
affiliation: Keller Army Community Hospital
name: Kenneth Cameron, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Christina Master, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin - Green Bay
name: Sadie Buboltz-Dubs, PhD
role: PRINCIPAL_INVESTIGATOR
References: