Clinical trial NCT03966404: EyeBOX Concussion Study and Registry
Official title: EyeBOX Concussion Study and Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Concussion, Brain
Mild Traumatic Brain Injury
Lead sponsor: Oculogica, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-29
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive subjects who meet all of the inclusion criteria and none of the exclusion criteria

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.


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.

Primary outcomes:
measure: diagnostic accuracy of initial clinical diagnosis of concussion
timeFrame: day 0 (when patient first presents for evaluation)
measure: diagnostic accuracy of clinical diagnosis of post-concussion symptoms
timeFrame: up to one year after initial presentation
measure: adverse events
timeFrame: through study participation, up to one year
Secondary outcomes:
measure: diagnostic accuracy of initial clinical diagnosis of concussion
timeFrame: day 0 (when patient first presents for evaluation)
measure: correlation with increases or decreases in post-concussion symptom severity
timeFrame: up to one year after initial presentation
Other outcomes:
Locations:
city: White Plains
country: United States
facility: New York Sports Medicine Institute
state: New York
Study officials:
affiliation: Oculogica, Inc.
name: Rosina Samadani, PhD
role: STUDY_DIRECTOR
References: