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EyeBOX Concussion Study and Registry

Study Description
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.

Condition or disease Intervention/treatment
Concussion, Brain Mild Traumatic Brain Injury Diagnostic Test: EyeBOX device

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: EyeBOX Concussion Study and Registry
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. diagnostic accuracy of initial clinical diagnosis of concussion [ Time Frame: day 0 (when patient first presents for evaluation) ]
    sensitivity and specificity compared to initial clinical diagnosis of concussion

  2. diagnostic accuracy of clinical diagnosis of post-concussion symptoms [ Time Frame: up to one year after initial presentation ]
    sensitivity and specificity compared to clinical diagnosis of post-concussion symptoms

  3. adverse events [ Time Frame: through study participation, up to one year ]
    adverse events occurring during use of the diagnostic device


Secondary Outcome Measures :
  1. diagnostic accuracy of initial clinical diagnosis of concussion [ Time Frame: day 0 (when patient first presents for evaluation) ]
    positive and negative predictive value compared to initial clinical diagnosis of concussion

  2. correlation with increases or decreases in post-concussion symptom severity [ Time Frame: up to one year after initial presentation ]
    diagnostic accuracy to identify increases or decreases in post-concussion symptom severity


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 22, 2019
First Posted Date May 29, 2019
Last Update Posted Date March 15, 2021
Actual Study Start Date August 5, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 28, 2019)
  • diagnostic accuracy of initial clinical diagnosis of concussion [ Time Frame: day 0 (when patient first presents for evaluation) ]
    sensitivity and specificity compared to initial clinical diagnosis of concussion
  • diagnostic accuracy of clinical diagnosis of post-concussion symptoms [ Time Frame: up to one year after initial presentation ]
    sensitivity and specificity compared to clinical diagnosis of post-concussion symptoms
  • adverse events [ Time Frame: through study participation, up to one year ]
    adverse events occurring during use of the diagnostic device
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 28, 2019)
  • diagnostic accuracy of initial clinical diagnosis of concussion [ Time Frame: day 0 (when patient first presents for evaluation) ]
    positive and negative predictive value compared to initial clinical diagnosis of concussion
  • correlation with increases or decreases in post-concussion symptom severity [ Time Frame: up to one year after initial presentation ]
    diagnostic accuracy to identify increases or decreases in post-concussion symptom severity
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title EyeBOX Concussion Study and Registry
Official Title EyeBOX Concussion Study and Registry
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All consecutive subjects who meet all of the inclusion criteria and none of the exclusion criteria
Condition
  • 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 28, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2022
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Rosina Samadani, PhD 9173024333 rosina@oculogica.com
Contact: Mark Stenoien 7632031032 mark@oculogica.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03966404
Other Study ID Numbers MTBI002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Oculogica, Inc.
Study Sponsor Oculogica, Inc.
Collaborators Not Provided
Investigators
Study Director: Rosina Samadani, PhD Oculogica, Inc.
PRS Account Oculogica, Inc.
Verification Date February 2021