Oculogica Portable EyeBOX Study

NCT05047003 | Completed FDA Device

• 1 other identifier: MTBI003
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Concussion, Brain; Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

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

  Up to one year after initial presentation

• Subgroup analyses

  Up to one year after initial presentation

• Diagnostic accuracy of initial clinical diagnosis of concussion

  Day 0 (when patient first presents for evaluation)

Study Arms (1)

Patients under evaluation for Suspected Concussion

Device: EyeBOX Model EBX-4 (Portable version)

Diagnostic Test: EyeBOX Model EBX-4 (Portable version)

Interventions

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.

Patients under evaluation for Suspected Concussion

Eligibility Criteria

• Age: 5 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• \. Have penetrating trauma or known skull fracture or intracranial injury.
• \. 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).
• \. 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.
• \. 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 prior history of unresolved ocular-motor dysfunctions.
• \. Be intoxicated.

Sponsors & Collaborators

• Oculogica, Inc.: lead

Study Sites (4)

Redlands Chiropractic

Redlands, California, 92373, United States

Location

CentraCare

Saint Cloud, Minnesota, 56303, United States

Location

Prevea Health

Green Bay, Wisconsin, 54303, United States

Location

Westfields Hospital

New Richmond, Wisconsin, 54017, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Rosina Samadani, PhD

  Oculogica, Inc.

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 16, 2021
• Study Start: December 19, 2020
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

US (4)