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Sponsor study identifier
observational
1,600
1 country
1
Study Start
July 1, 2023
Actual (reported)Primary Completion
August 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 26, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 26, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 30, 2022
Actual (reported)September 2, 2022
Actual (reported)July 1, 2023
Actual (reported)August 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 26, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Within 72 hours of injury
Diagnostic accuracy of recovery determination for return to activity and duty (RTA / RTD) using EBLens form factor and algorithm
Through study completion, up to one year
Subjects age 17-34 years within 72 hours of injury.
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.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Keller Army Hospital
West Point, New York, 10996, United States
Kenneth Cameron, PhD
Keller Army Community Hospital
Christina Master, MD
Children's Hospital of Philadelphia
Sadie Buboltz-Dubs, PhD
University of Wisconsin - Green Bay
First Submitted
August 30, 2022
First Posted
September 2, 2022
Study Start
July 1, 2023
Actual (reported)Primary Completion
August 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
September 26, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 31, 2025
Record last verified: 2025-03
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Source: ClinicalTrials.gov.
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