Traumatic Brain InjuryRETINANCT01552577
The RETINA Project: Reliable Eye Tracking in Neurocognitive Assessment of Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Uniformed Services University of the Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to develop and validate eye-tracking measures that can be used to evaluate neurocognitive dysfunction among individuals with traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population to be studied will include civilians and military personnel with and without a history of traumatic brain injury / concussion.
Who may be able to join
- 18 years of age or older
- No history of brain injury or concussion
- Fluency and literacy in English
- Can effectively communicate verbally
- Willing and able to provide written informed consent
- Obtains signed permission to participate from supervisor and/or brigade commander (federal civilian employees and active duty military personnel only).
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- 18 years of age or older
- History of one or more brain injuries / concussion
- Fluency and literacy in English
- Can effectively communicate verbally
- Willing and able to provide written informed consent
- Obtains signed permission to participate from supervisor and/or brigade commander (federal civilian employees and active duty military personnel only).
Who cannot join
- Impaired or fluctuating level of consciousness / arousal
- Any medical condition that could impair cognitive abilities (e.g. muscular dystrophy, multiple sclerosis, psychosis)
- History of any neurological conditions such as brain tumor, brain infection, seizure or stroke
- Any visual impairment that is not corrected by glasses/contacts
- Motor impairment or amputation of one or both upper extremities
- Impaired or fluctuating level of consciousness / arousal
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- Any medical condition that could impair cognitive abilities (e.g. muscular dystrophy, multiple sclerosis, psychosis), other than TBI
- History of any neurological conditions (such as brain tumor, brain infection, seizure or stroke) that was NOT associated with or resulting from traumatic brain injury
- Any visual impairment that is not corrected by glasses/contacts
- Motor impairment or amputation of one or both upper extremities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eye Tracking Indicators of Neurocognitive Status After Traumatic Brain Injury
The purpose of this study is to develop and validate eye-tracking measures that can be used to evaluate neurocognitive dysfunction among individuals with traumatic brain injury (TBI).
Read the detailed description
This study will evaluate a novel method of neurocognitive assessment using computerized eye tracking. This method involves looking at targets on a computer screen while an eye-tracking system records eye movements and changes in pupil diameter in response to the presentation of the targets.
Performance on the eye tracking measures will be evaluated to identify potential effects of neural injury on cognitive performance. Data from individuals with and without a history of brain injury will be used to standardize the eye tracking measure.
Participants will also complete a short interview and several self report measures, including information about demographic characteristics, medical history, and psychological symptoms, along with a series of neuropsychological/cognitive measures that are already well established. Performance on eye tracking measures will then be compared to performance on these conventional cognitive tests to allow comparison of the different measures.
All participants will complete one visit to the laboratory at USUHS in Bethesda, MD. This visit will take approximately 2.5 hours. Participants without a history of TBI may be asked to return for a 30 minute follow-up session in order to measure the reliability of the eye tracking system. Participants with a history of TBI will complete a 10 minute telephone follow-up 6 and 12 months after their visit.
Compensation is available for civilians who are not employed by the Federal government.
- Conditions
- Traumatic Brain Injury
- Keywords
- Post-Concussion Syndrome, Concussion, Brain Injury, TBI, Military Personnel, Eye-tracking, Neurocognitive Function, Assessment
- Medical subject headings
- Brain Injuries, Traumatic, Post-Concussion Syndrome, Brain Concussion, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TBI Group | Adults (civilian or military) with a history of one or more brain injuries / concussions. | |
| Control Group | Healthy adults (civilian or military) with no history of brain injury. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on the eye tracking measures
Measured: Baseline
Secondary outcomes (3)
Psychological symptoms
Measured: Baseline
Performance on the neurocognitive assessment battery
Measured: Baseline
Post-concussive symptoms
Measured: Baseline (and telephone follow-up, for TBI group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startOct 2010
- Primary completionAug 2015
- Study completionOct 2017
Why it stopped: Expiration of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Mark Ettenhofer, Uniformed Services University of the Health Sciences
- Investigators
- Mark Ettenhofer, Ph.D, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552577
- Sponsor's protocol ID
- R072LP-SS3
- Acronym
- RETINA
- Status last verified
- Dec 2018
- First submitted
- 8 Mar 2012
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye Tracking Indicators of Neurocognitive Status After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01552577
- Acronym / sponsor ID
- RETINA / R072LP-SS3
- Conditions
- Traumatic Brain Injury
- Keywords
- Post-Concussion Syndrome, Concussion, Brain Injury, TBI, Military Personnel, Eye-tracking, Neurocognitive Function, Assessment
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Expiration of funding
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Study start
- Oct 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 13 Mar 2012 (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 develop and validate eye-tracking measures that can be used to evaluate neurocognitive dysfunction among individuals with traumatic brain injury (TBI).
Detailed description
This study will evaluate a novel method of neurocognitive assessment using computerized eye tracking. This method involves looking at targets on a computer screen while an eye-tracking system records eye movements and changes in pupil diameter in response to the presentation of the targets.
Performance on the eye tracking measures will be evaluated to identify potential effects of neural injury on cognitive performance. Data from individuals with and without a history of brain injury will be used to standardize the eye tracking measure.
Participants will also complete a short interview and several self report measures, including information about demographic characteristics, medical history, and psychological symptoms, along with a series of neuropsychological/cognitive measures that are already well established. Performance on eye tracking measures will then be compared to performance on these conventional cognitive tests to allow comparison of the different measures.
All participants will complete one visit to the laboratory at USUHS in Bethesda, MD. This visit will take approximately 2.5 hours. Participants without a history of TBI may be asked to return for a 30 minute follow-up session in order to measure the reliability of the eye tracking system. Participants with a history of TBI will complete a 10 minute telephone follow-up 6 and 12 months after their visit.
Compensation is available for civilians who are not employed by the Federal government.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI Group | – | –Adults (civilian or military) with a history of one or more brain injuries / concussions. |
| Control Group | – | –Healthy adults (civilian or military) with no history of brain injury. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population to be studied will include civilians and military personnel with and without a history of traumatic brain injury / concussion.
Key inclusion criteria (12 listed)
- 18 years of age or older
- No history of brain injury or concussion
- Fluency and literacy in English
- Can effectively communicate verbally
- Willing and able to provide written informed consent
Key exclusion criteria (10 listed)
- Impaired or fluctuating level of consciousness / arousal
- Any medical condition that could impair cognitive abilities (e.g. muscular dystrophy, multiple sclerosis, psychosis)
- History of any neurological conditions such as brain tumor, brain infection, seizure or stroke
- Any visual impairment that is not corrected by glasses/contacts
- Motor impairment or amputation of one or both upper extremities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance on the eye tracking measures
Time frame: Baseline
3 secondary outcomes
Psychological symptoms
Time frame: Baseline
Performance on the neurocognitive assessment battery
Time frame: Baseline
Post-concussive symptoms
Time frame: Baseline (and telephone follow-up, for TBI group)
Results and safety
The study was stopped early (reason given: Expiration of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
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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.
Mark Ettenhofer, Ph.D principal investigator
Uniformed Services University of the Health Sciences
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 Traumatic Brain Injury, run by Uniformed Services University of the Health Sciences 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 12 inclusion and 10 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: stopped early, as of the sponsor's last update on 17 Dec 2018. 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 was stopped early (reason given: Expiration of funding). Results are not available in the source record.
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?
Performance on the eye tracking measures (time frame: Baseline). 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 17 Dec 2018.