Oculogica Portable EyeBOX Study

Mild Traumatic Brain Injury Clinical Trial

— RESTLESS  

Official title:

Oculogica Portable EyeBOX Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05047003
• Other study ID #: MTBI003
• Status: Completed
• Start date: December 19, 2020
• Est. completion date: October 1, 2022

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Prevea Health	Green Bay	Wisconsin
United States	Westfields Hospital	New Richmond	Wisconsin
United States	Redlands Chiropractic	Redlands	California
United States	CentraCare	Saint Cloud	Minnesota

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 the initial 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 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 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
Secondary	Subgroup analyses	Subgroup analyses will be performed by age, gender, and days since incident injury	Up to one year after initial presentation
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)