EyeBOX Concussion Study and Registry

Mild Traumatic Brain Injury Clinical Trial

Official title:

EyeBOX Concussion Study and Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966404
• Other study ID #: MTBI002
• Status: Completed
• Start date: August 5, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2023
• Source: Oculogica, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion, Brain
• Mild Traumatic Brain Injury

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	New York Sports Medicine Institute	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Oculogica, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	adverse events	adverse events occurring during use of the diagnostic device	through study participation, up to one year
Secondary	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)
Secondary	correlation with increases or decreases in post-concussion symptom severity	diagnostic accuracy to identify increases or decreases in post-concussion symptom severity	up to one year after initial presentation