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OpenTrials
Completed

NCT Number: NCT05047003

Oculogica Portable EyeBOX Study

The objective of this study is to assess the accuracy of a portable version of the EyeBOX device, an eye-tracking based diagnostic, in comparison to a clinical reference standard of concussion. The utility of the portable assessment to aid in the monitoring of symptoms over time after an initial diagnosis of concussion will also be evaluated.

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Key information

Conditions

Concussion, Brain Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Mild Traumatic Brain Injury Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

5 year–67 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Redlands Chiropractic, Redlands, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. Provide documented informed consent or assent along with guardian consent.
  • 2. 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.
  • 3. Be 5 to 67 years of age, inclusive.
  • 4. Have the ability to provide a complete ophthalmologic, medical, and neurologic history as well as report current medications.

Exclusion criteria

  • 1. Have penetrating trauma or known skull fracture or intracranial injury.
  • 2. 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).
  • 3. Any of the following conditions, immediately related to the incident injury: loss of consciousness exceeding 30 minutes or best available Glasgow Coma Scale (GCS) score less than 13 within 24 hours or other acute conditions requiring emergency medical management.
  • 4. Be blind (no light perception), have missing or non-functional eyes.
  • 5. Be unable to open their eyes.
  • 6. Have a history of unresolved strabismus, diplopia, amblyopia.
  • 7. Have a history of unresolved cranial nerve III, IV, or VI palsy.
  • 8. Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
  • 9. 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).
  • 10. Have a prior history of unresolved ocular-motor dysfunctions.
  • 11. Be intoxicated.

Treatment and study plan

EyeBOX Model EBX-4 (Portable version)

Diagnostic Test

The portable EyeBOX takes less than 4 minutes to complete and involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high-speed camera continuously records gaze positions. The Portable EyeBOX software detects subtle changes in eye movements consistent with concussion and calculates a BOX score.

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 the initial 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 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 to identify increases or decreases in post-concussion symptom severity

    Time frame: Up to one year after initial presentation

    Correlation with increases or decreases in post-concussion symptom severity

  2. Subgroup analyses

    Time frame: Up to one year after initial presentation

    Subgroup analyses will be performed by age, gender, and days since incident injury

  3. 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

Sponsors and collaborators

Lead sponsor

Oculogica, Inc.

Industry

Registry information

Acronym: RESTLESS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2021
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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