Oculogica Portable EyeBOX Study (RESTLESS)

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.

Study Overview

• Status: Completed
• Conditions: Mild Traumatic Brain Injury; Concussion, Brain
• Intervention / Treatment: Diagnostic test: EyeBOX Model EBX-4 (Portable version)

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • California
    • Redlands, California, United States, 92373
      • Redlands Chiropractic
  • Minnesota
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54303
      • Prevea Health
    • New Richmond, Wisconsin, United States, 54017
      • Westfields Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 67 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All consecutive subjects who meet all of the inclusion criteria and none of the exclusion criteria

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients under evaluation for Suspected Concussion; Device: EyeBOX Model EBX-4 (Portable version)

Diagnostic test: EyeBOX Model EBX-4 (Portable version); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of initial clinical diagnosis of concussion	Sensitivity and Specificity compared to the initial diagnosis of concussion	Day 0 (when patient first presents for evaluation)
Diagnostic accuracy of clinical diagnosis of post-concussion symptoms	Sensitivity and Specificity compared to post-concussion symptoms	Up to one year after initial presentation
Adverse Events	Adverse events occurring during use of the diagnostic device	Through study participation, up to one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy to identify increases or decreases in post-concussion symptom severity	Correlation with increases or decreases in post-concussion symptom severity	Up to one year after initial presentation
Subgroup analyses	Subgroup analyses will be performed by age, gender, and days since incident injury	Up to one year after initial presentation
Diagnostic accuracy of initial clinical diagnosis of concussion	Positive and negative predictive value compared to initial clinical diagnosis of concussion	Day 0 (when patient first presents for evaluation)

Collaborators and Investigators

• Sponsor: Oculogica, Inc.
• Investigators: Study Director: Rosina Samadani, PhD, Oculogica, Inc.; Principal Investigator: Amy Romandine-Kratz, MD, Prevea Health; Principal Investigator: Mario Chavez, DC, Redlands Chiropractic; Principal Investigator: Brian Lease, PT, Westfields Hospital; Principal Investigator: Yang K Lo, MD, CentraCare

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2020
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: MTBI003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No