Concussion, BrainNCT03966404
EyeBOX Concussion Study and Registry
An observational study of Concussion, Brain and Mild Traumatic Brain Injury, run by Oculogica, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Concussion, Brain, Mild Traumatic Brain Injury
- What is being tested?
- EyeBOX device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2019to 1 Jun 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive subjects who meet all of the inclusion criteria and none of the exclusion criteria
Who may be able to join
- Provide written informed consent or assent along with guardian consent.
- 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.
- 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.
Who cannot join
- Have penetrating trauma.
- 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).
- 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.
- Be blind (no light perception), have missing or non-functional eyes.
- Be unable to open their eyes.
- Have a history of unresolved strabismus, diplopia, amblyopia.
Show all 11Show fewer
- Have a history of unresolved cranial nerve III, IV, or VI palsy.
- Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
- 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.
- Have a prior history of unresolved ocular-motor dysfunctions.
- Be intoxicated.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Sports Medicine Institute
White Plains, New York, 10604
About this study
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
- Being tested
- EyeBOX device
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyeBOX deviceDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy of initial clinical diagnosis of concussion
sensitivity and specificity compared to initial clinical diagnosis of concussion
Measured: day 0 (when patient first presents for evaluation)
diagnostic accuracy of clinical diagnosis of post-concussion symptoms
sensitivity and specificity compared to clinical diagnosis of post-concussion symptoms
Measured: up to one year after initial presentation
adverse events
adverse events occurring during use of the diagnostic device
Measured: through study participation, up to one year
Secondary outcomes (2)
diagnostic accuracy of initial clinical diagnosis of concussion
positive and negative predictive value compared to initial clinical diagnosis of concussion
Measured: day 0 (when patient first presents for evaluation)
correlation with increases or decreases in post-concussion symptom severity
diagnostic accuracy to identify increases or decreases in post-concussion symptom severity
Measured: up to one year after initial presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start5 Aug 2019
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Oculogica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rosina Samadani, PhD, Study director, Oculogica, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966404
- Sponsor's protocol ID
- MTBI002
- Status last verified
- Sep 2023
- First submitted
- 22 May 2019
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EyeBOX Concussion Study and Registry
- ClinicalTrials.gov ID
- NCT03966404
- Acronym / sponsor ID
- MTBI002
- Conditions
- Concussion, Brain, Mild Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Oculogica, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive subjects who meet all of the inclusion criteria and none of the exclusion criteria
Key inclusion criteria (3 listed)
- Provide written informed consent or assent along with guardian consent.
- 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.
- 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.
Key exclusion criteria (11 listed)
- Have penetrating trauma.
- 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).
- 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.
- Be blind (no light perception), have missing or non-functional eyes.
- Be unable to open their eyes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EyeBOX deviceThe 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. | Diagnostic test | – |
Primary outcome
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
2 secondary outcomes
diagnostic accuracy of initial clinical diagnosis of concussion
Time frame: day 0 (when patient first presents for evaluation)
correlation with increases or decreases in post-concussion symptom severity
Time frame: up to one year after initial presentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosina Samadani, PhD study director
Oculogica, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Brain and Mild Traumatic Brain Injury, run by Oculogica, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy of initial clinical diagnosis of concussion (time frame: day 0 (when patient first presents for evaluation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.