Brain ConcussionDETECTNCT02776462
Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients
An observational study of Brain Concussion and Cerebral Concussion, run by Oculogica, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for the Emergency Department (ED) or concussion clinic. Read more about this study
- Who is it for?
- Ages 5 to 67 years
- Conditions the study is for
- Brain Concussion, Cerebral Concussion, Concussion, Intermediate
- What is being tested?
- EyeBox CNS
- Type of treatment
- Medical device
- How many people
- 321 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2016to 19 Jun 2018
- 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: Participants will include all patients evaluated for potential traumatic brain injury presenting to the Emergency Department or concussion clinic.
Who may be able to join
- Provide written informed consent.
- Be between the ages of 4 and 67 years old.
- Have a diagnosis of traumatic brain injury with a potential for concussion.
- Subjects must have baseline vision correctable to within 20/500 bilaterally.
- Subjects must have intact ocular motility.
- Subjects must have ability to provide a complete ophthalmologic, medical and neurologic history as well as medications/drugs/alcohol consumed within the 24 hours prior.
Who cannot join
- ER visit has been more than 2 weeks since the injury which may have caused the concussion.
- Have received penetrating trauma or have a head CT demonstrating evidence of acute brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read).
- Suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability.
- Blind (no light perception), are missing eyes, do not open eyes.
- It is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant.
- Previous history of: ocular motility dysfunction or extensive prior eye surgery.
- Any physical or mental injury or baseline disability rendering task completion difficult.
- Obvious intoxication or blood alcohol level greater than 0.2.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beaver Dam Community Hospital
Beaver Dam, Wisconsin, 53916
SkyRidge Medical Center
Lone Tree, Colorado, 80124
About this study
The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for the Emergency Department (ED) or concussion clinic.
- Conditions
- Brain Concussion, Cerebral Concussion, Concussion, Intermediate, Concussion, Mild, Concussion, Severe, Trauma, Nervous System
- Being tested
- EyeBox CNS
- Keywords
- Eye Tracking, Concussion, Outcome Measures
- Medical subject headings
- Brain Concussion, Trauma, Nervous System, Craniocerebral Trauma, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyeBox CNSDevice
| Study group | Role | What they receive |
|---|---|---|
| Potential Traumatic Brain Injury | This group will consist of people admitted to the ER, Trauma Bay, or Neurosurgery for potential traumatic brain injury. Receives: Device: EyeBox CNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in metrics of eye movement that enable positive concussion detection using BOX Score.
A True Positive rate for identifying Concussion as compared to a Clinical Reference standard.
Measured: Immediately after eye tracking, within 2 weeks of injury
Secondary outcomes (1)
Change in Cognitive Function and Symptom Severity during Recovery as Measured with a Clinical Reference Standard for Concussion.
Measured: Immediately before eye tracking, between 1 week and 109 weeks post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startJun 2016
- Primary completion16 Nov 2017
- Study completion19 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain ConcussionStudies 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
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oculogica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uzma Samadani, M.D., Ph.D., Study chair, Hennepin County Medical Center, Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776462
- Sponsor's protocol ID
- DETECT TBI001
- Acronym
- DETECT
- Status last verified
- Sep 2018
- First submitted
- 16 May 2016
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Samadani U. A new tool for monitoring brain function: eye tracking goes beyond assessing attention to measuring central nervous system physiology. Neural Regen Res. 2015 Aug;10(8):1231-3. doi: 10.4103/1673-5374.162752. No abstract available.
PubMed 26487847Samadani U, Ritlop R, Reyes M, Nehrbass E, Li M, Lamm E, Schneider J, Shimunov D, Sava M, Kolecki R, Burris P, Altomare L, Mehmood T, Smith T, Huang JH, McStay C, Todd SR, Qian M, Kondziolka D, Wall S, Huang P. Eye tracking detects disconjugate eye movements associated with structural traumatic brain injury and concussion. J Neurotrauma. 2015 Apr 15;32(8):548-56. doi: 10.1089/neu.2014.3687. Epub 2015 Feb 6.
PubMed 25582436Samadani U, Farooq S, Ritlop R, Warren F, Reyes M, Lamm E, Alex A, Nehrbass E, Kolecki R, Jureller M, Schneider J, Chen A, Shi C, Mendhiratta N, Huang JH, Qian M, Kwak R, Mikheev A, Rusinek H, George A, Fergus R, Kondziolka D, Huang PP, Smith RT. Detection of third and sixth cranial nerve palsies with a novel method for eye tracking while watching a short film clip. J Neurosurg. 2015 Mar;122(3):707-20. doi: 10.3171/2014.10.JNS14762. Epub 2014 Dec 12.
PubMed 25495739
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients
- ClinicalTrials.gov ID
- NCT02776462
- Acronym / sponsor ID
- DETECT / DETECT TBI001
- Conditions
- Brain Concussion, Cerebral Concussion, Concussion, Intermediate, Concussion, Mild, Concussion, Severe, Trauma, Nervous System
- Keywords
- Eye Tracking, Concussion, Outcome Measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Oculogica, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- 16 Nov 2017 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 18 May 2016 (estimated)
- 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 purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for the Emergency Department (ED) or concussion clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Potential Traumatic Brain Injury | – | Device: EyeBox CNSThis group will consist of people admitted to the ER, Trauma Bay, or Neurosurgery for potential traumatic brain injury. |
Who may qualify
- Ages
- 5 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will include all patients evaluated for potential traumatic brain injury presenting to the Emergency Department or concussion clinic.
Key inclusion criteria (6 listed)
- Provide written informed consent.
- Be between the ages of 4 and 67 years old.
- Have a diagnosis of traumatic brain injury with a potential for concussion.
- Subjects must have baseline vision correctable to within 20/500 bilaterally.
- Subjects must have intact ocular motility.
Key exclusion criteria (8 listed)
- ER visit has been more than 2 weeks since the injury which may have caused the concussion.
- Have received penetrating trauma or have a head CT demonstrating evidence of acute brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read).
- Suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability.
- Blind (no light perception), are missing eyes, do not open eyes.
- It is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant.
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 CNS | Device | Potential Traumatic Brain Injury |
Primary outcome
A change in metrics of eye movement that enable positive concussion detection using BOX Score.
Time frame: Immediately after eye tracking, within 2 weeks of injury
A True Positive rate for identifying Concussion as compared to a Clinical Reference standard.
1 secondary outcome
Change in Cognitive Function and Symptom Severity during Recovery as Measured with a Clinical Reference Standard for Concussion.
Time frame: Immediately before eye tracking, between 1 week and 109 weeks post injury
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 2018.
- Background: PubMed 26487847Samadani U. A new tool for monitoring brain function: eye tracking goes beyond assessing attention to measuring central nervous system physiology. Neural Regen Res. 2015 Aug;10(8):1231-3. doi: 10.4103/1673-5374.162752. No abstract available.
- Background: PubMed 25582436Samadani U, Ritlop R, Reyes M, Nehrbass E, Li M, Lamm E, Schneider J, Shimunov D, Sava M, Kolecki R, Burris P, Altomare L, Mehmood T, Smith T, Huang JH, McStay C, Todd SR, Qian M, Kondziolka D, Wall S, Huang P. Eye tracking detects disconjugate eye movements associated with structural traumatic brain injury and concussion. J Neurotrauma. 2015 Apr 15;32(8):548-56. doi: 10.1089/neu.2014.3687. Epub 2015 Feb 6.
- Background: PubMed 25495739Samadani U, Farooq S, Ritlop R, Warren F, Reyes M, Lamm E, Alex A, Nehrbass E, Kolecki R, Jureller M, Schneider J, Chen A, Shi C, Mendhiratta N, Huang JH, Qian M, Kwak R, Mikheev A, Rusinek H, George A, Fergus R, Kondziolka D, Huang PP, Smith RT. Detection of third and sixth cranial nerve palsies with a novel method for eye tracking while watching a short film clip. J Neurosurg. 2015 Mar;122(3):707-20. doi: 10.3171/2014.10.JNS14762. Epub 2014 Dec 12.
- Individual participant dataSharing planned: No
Related trials for Brain Concussion
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
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.
Uzma Samadani, M.D., Ph.D. study chair
Hennepin County Medical Center, Minneapolis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Concussion and Cerebral Concussion, run by Oculogica, Inc. at 2 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 6 inclusion and 8 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 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
A change in metrics of eye movement that enable positive concussion detection using BOX Score. (time frame: Immediately after eye tracking, within 2 weeks of injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02776462, which also lists 3 linked publications.
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 2018.