EyeBOX Concussion Study and Registry

NCT ID: NCT03966404

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-05
• Study Completion Date: 2023-06-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

EyeBOX device

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Provide written informed consent or assent along with guardian consent.

2. 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.

3. 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

1. Have penetrating trauma.

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. 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.

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 (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.

10. Have a prior history of unresolved ocular-motor dysfunctions.

11. Be intoxicated.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oculogica, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rosina Samadani, PhD

Role: STUDY_DIRECTOR

Oculogica, Inc.

Locations

New York Sports Medicine Institute

White Plains, New York, United States

Countries

United States

Other Identifiers

MTBI002

Identifier Type: -

Identifier Source: org_study_id