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OpenTrials
Completed

NCT Number: NCT03966404

EyeBOX Concussion Study and Registry

The objective of this study is to further evaluate eye movements as an aid in the diagnosis of concussion / mTBI and the utility of eye movement assessment in the monitoring of symptoms over time after an initial diagnosis of concussion.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provide written informed consent or assent along with guardian consent.
  • Have sustained a suspected direct or indirect force to the head with or without documented loss of consciousness, memory loss, alteration in consciousness or neurologic deficits. Only individuals presenting for initial evaluation of concussion may be enrolled, however longitudinal assessments may be conducted on enrolled subjects.
  • Have the ability to provide a complete ophthalmologic, medical and neurologic history as well as report medications/drugs/alcohol consumed within the 24 hours prior to tracking.

Exclusion criteria

  • Have penetrating trauma.
  • 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).
  • Either of the following conditions, immediately related to the incident head trauma: loss of consciousness exceeding 30 minutes or best available GCS score less than 13 within 24 hours.
  • 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 (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) or scarring.
  • Have a prior history of unresolved ocular-motor dysfunctions.
  • Be intoxicated.

Treatment and study plan

EyeBOX device

Diagnostic Test

The EyeBOX medical device tracks a patient's eye movement and calculates a BOX Score ranging from 0-20. The BOX score is interpreted as a binary classification for eye movement abnormalities, where anything equal to or greater than 10 is a positive result for the initial evaluation of concussion and everything below 10 is negative.

Primary outcomes

  1. diagnostic accuracy of initial clinical diagnosis of concussion

    Time frame: day 0 (when patient first presents for evaluation)

    sensitivity and specificity compared to initial clinical diagnosis of concussion

  2. diagnostic accuracy of clinical diagnosis of post-concussion symptoms

    Time frame: up to one year after initial presentation

    sensitivity and specificity compared to clinical diagnosis of post-concussion symptoms

  3. adverse events

    Time frame: through study participation, up to one year

    adverse events occurring during use of the diagnostic device

Secondary outcomes

  1. diagnostic accuracy of initial clinical diagnosis of concussion

    Time frame: day 0 (when patient first presents for evaluation)

    positive and negative predictive value compared to initial clinical diagnosis of concussion

  2. correlation with increases or decreases in post-concussion symptom severity

    Time frame: up to one year after initial presentation

    diagnostic accuracy to identify increases or decreases in post-concussion symptom severity

Sponsors and collaborators

Lead sponsor

Oculogica, Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 29, 2019
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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