Concussion, BrainRESTLESSNCT05047003
Oculogica Portable EyeBOX Study
An observational study of Concussion, Brain and Mild Traumatic Brain Injury, run by Oculogica, Inc. at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 67 years
- Conditions the study is for
- Concussion, Brain, Mild Traumatic Brain Injury
- What is being tested?
- EyeBOX Model EBX-4 (Portable version)
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Dec 2020to 1 Oct 2022
- 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 5 to 67 years
- 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
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Prevea Health
Green Bay, Wisconsin, 54303
Westfields Hospital
New Richmond, Wisconsin, 54017
Redlands Chiropractic
Redlands, California, 92373
CentraCare
Saint Cloud, Minnesota, 56303
About this study
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.
- Conditions
- Concussion, Brain, Mild Traumatic Brain Injury
- Being tested
- EyeBOX Model EBX-4 (Portable version)
- 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 Model EBX-4 (Portable version)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients under evaluation for Suspected Concussion | Device: EyeBOX Model EBX-4 (Portable version) Receives: Diagnostic Test: EyeBOX Model EBX-4 (Portable version) |
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 the initial 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 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 (3)
Diagnostic accuracy to identify increases or decreases in post-concussion symptom severity
Correlation with increases or decreases in post-concussion symptom severity
Measured: Up to one year after initial presentation
Subgroup analyses
Subgroup analyses will be performed by age, gender, and days since incident injury
Measured: Up to one year after initial presentation
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start19 Dec 2020
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oculogica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rosina Samadani, PhD, Study director, Oculogica, Inc.Amy Romandine-Kratz, MD, Principal investigator, Prevea HealthMario Chavez, DC, Principal investigator, Redlands ChiropracticBrian Lease, PT, Principal investigator, Westfields HospitalYang K Lo, MD, Principal investigator, CentraCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047003
- Sponsor's protocol ID
- MTBI003
- Acronym
- RESTLESS
- Status last verified
- Sep 2023
- First submitted
- 10 Sep 2021
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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
- Oculogica Portable EyeBOX Study
- ClinicalTrials.gov ID
- NCT05047003
- Acronym / sponsor ID
- RESTLESS / MTBI003
- Conditions
- Concussion, Brain, Mild Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Oculogica, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 16 Sep 2021 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients under evaluation for Suspected Concussion | – | Diagnostic Test: EyeBOX Model EBX-4 (Portable version)Device: EyeBOX Model EBX-4 (Portable version) |
Who may qualify
- Ages
- 5 to 67 years
- 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 (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 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. | Diagnostic test | Patients under evaluation for Suspected Concussion |
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 the initial 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 post-concussion symptoms
Adverse Events
Time frame: Through study participation, up to one year
Adverse events occurring during use of the diagnostic device
3 secondary outcomes
Diagnostic accuracy to identify increases or decreases in post-concussion symptom severity
Time frame: Up to one year after initial presentation
Subgroup analyses
Time frame: Up to one year after initial presentation
Diagnostic accuracy of initial clinical diagnosis of concussion
Time frame: Day 0 (when patient first presents for evaluation)
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.
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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.
Amy Romandine-Kratz, MD principal investigator
Prevea Health
Mario Chavez, DC principal investigator
Redlands Chiropractic
4 sites 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 4 sites 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 4 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 4 sites 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.