EyeBOX Concussion Study and Registry

NCT03966404 | Completed FDA Device

• 1 other identifier: MTBI002
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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 initial clinical 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 clinical diagnosis of 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 (2)

• diagnostic accuracy of initial clinical diagnosis of concussion

  day 0 (when patient first presents for evaluation)

• correlation with increases or decreases in post-concussion symptom severity

  up to one year after initial presentation

Interventions

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.

Eligibility Criteria

• 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 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.

You may not qualify if:

• 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 prior history of unresolved ocular-motor dysfunctions.
• Be intoxicated.

Sponsors & Collaborators

• Oculogica, Inc.: lead

Study Sites (1)

New York Sports Medicine Institute

White Plains, New York, 10604, 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 29, 2019
• Study Start: August 5, 2019
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

US (1)