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

Part of paid clinical trials in West Point, New York.

Sponsor
Oculogica, Inc.
Study ID
NCT05527041
Status
Enrolling By Invitation

Conditions

  • Concussion, Brain
  • Mild Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
17 Years - 35 Years
Healthy Volunteers
Accepted

Interventions

  • 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 Details

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.

Key Dates

Start date
Jul 1, 2023
Status verified
Mar 2025
Primary completion
Aug 1, 2025
Completion
Sep 26, 2025

Study Design

Enrollment
1,600 participants (estimated)

Arms

  • Arm: Concussed
    Subjects age 17-34 years within 72 hours of injury.
  • Arm: 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.

Primary Outcome Measure

Diagnostic accuracy of acute clinical diagnosis of concussion using EBLens form factor and algorithm [ Time Frame: Within 72 hours of injury ]

Locations (1)

FacilityCityStateZIPSite coordinators
Keller Army HospitalWest PointNew York10996-

Find similar trials in West Point, NY

By research site
Keller Army Hospital· West Point, NY

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