Post Concussive Syndrome, ChronicEye-TRACNCT00743821
Eye-Tracking Rapid Attention Computation
An observational study of Post Concussive Syndrome, Chronic, run by Brain Trauma Foundation at 1 site in United States.
Trial summary
The purpose of this study is to validate and refine a diagnostic device that can detect attention and memory deficits that result from mild traumatic brain injury (mTBI). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Concussive Syndrome, Chronic
- How many people
- 426 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Sep 2012
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: TBI patients will be recruited from an outpatient TBI clinic Normals will be friends/family of TBI patients who have not suffered a TBI, as well as individuals recruited from the community
Who may be able to join
- Healthy volunteer
- Education up to 12th grade
- Education up to 12th grade
- Persistent post concussive symptoms after an isolated incident of head injury with or without loss of consciousness between 3 months to 5 years prior to participation
Who cannot join
- History of concussion or TBI
- Alcohol or substance abuse problems, neurological disorders, major psychiatric disorders (including ADHD or PTSD)
- Gross visual or hearing problems
- Pregnancy
- Metal in the body or any contraindications for MRI
- TBI Patients:
Show all 11Show fewer
- Prior history of seizures
- Pregnant woman
- Alcohol or substance abuse problems, neurological disorders, major psychiatric disorders (including ADHD or PTSD)
- Gross visual or hearing problems
- Any metal in the body or contraindications for MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Citigroup Imaging Center, Weill Medical College of Cornell University
New York, New York, 10021
About this study
The purpose of this study is to validate and refine a diagnostic device that can detect attention and memory deficits that result from mild traumatic brain injury (mTBI).
Read the detailed description
The main goal of this project is the development of a military-ready, sensitive and rapid eye tracking diagnostic device for individuals with mild traumatic brain injury (mTBI). The device will also be tested for its efficacy in diagnosing fatigue and identifying aging effects. We will use a predictive visual tracking paradigm to dynamically capture the attentional state and correlate the subject's performance with the degree of disruption in the attention network caused by mTBI, aging and fatigue. The device will be tested for its diagnostic capabilities based on its selectivity, reliability, sensitivity and validity for individuals of varying ages (with and without mTBI) and in military personnel who have undergone 26 hours of sleep deprivation.
Testing will be conducted at two sites:
- Civilians with mTBI; and civilians with adult attention deficit hyperactivity disorder will be tested by trained staff of the Brain Trauma Foundation (BTF) at Weill Cornell Medical College (WCMC) in New York City. The ages of the enrolled individuals will range between 18-55 years in order to examine aging effects.
- Enrolled service members will be tested at the United States Army Research Institute of Environmental Medicine (USARIEM) in Natick, Massachusetts. These service members will be healthy volunteers without a history of mTBI. Some of these subjects will undergo 26 hours of sleep deprivation during which they will be tested at specific time points.
Our objectives are:
- Prove that the eye-tracking concept can be brought from a successful laboratory device to a specific, reliable, selective, and valid diagnostic tool.
1.1. Test reliability by examining the test-retest reliability measures of EYE-TRAC;
1.2. Test selectivity by testing the ability to differentiating the effects of fatigue, aging, and mTBI on EYE-TRAC measures;
1.3. Test validity by determining the relationship between measures of attention and working memory based on the EYE-TRAC and validated measures of sustained attention and working memory;
1.4. Test specificity by measuring the spectrum of TBI injury using MRI-DTI and correlate with EYE-TRAC.
- Conditions
- Post Concussive Syndrome, Chronic
- Medical subject headings
- Post-Concussion Syndrome
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 Patients | Individuals who have suffered a mild traumatic brain injury and have persistent post-concussive symptoms (PCS) | |
| Normals | Individuals of comparable age and education who have not suffered a traumatic brain injury |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Concussive Syndrome, ChronicStudies 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
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain Trauma Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Jamshid Ghajar, M.D., Ph.D., Brain Trauma Foundation
- Investigators
- Jamshid Ghajar, M.D., Ph.D., Principal investigator, Brain Trauma Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743821
- Sponsor's protocol ID
- PT075553
- Other IDs
- IRB Protocol #0211005884
- Acronym
- Eye-TRAC
- Status last verified
- May 2014
- First submitted
- 28 Aug 2008
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye-Tracking Rapid Attention Computation
- ClinicalTrials.gov ID
- NCT00743821
- Acronym / sponsor ID
- Eye-TRAC / PT075553
- Conditions
- Post Concussive Syndrome, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Brain Trauma FoundationUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Oct 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Aug 2008 (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 validate and refine a diagnostic device that can detect attention and memory deficits that result from mild traumatic brain injury (mTBI).
Detailed description
The main goal of this project is the development of a military-ready, sensitive and rapid eye tracking diagnostic device for individuals with mild traumatic brain injury (mTBI). The device will also be tested for its efficacy in diagnosing fatigue and identifying aging effects. We will use a predictive visual tracking paradigm to dynamically capture the attentional state and correlate the subject's performance with the degree of disruption in the attention network caused by mTBI, aging and fatigue. The device will be tested for its diagnostic capabilities based on its selectivity, reliability, sensitivity and validity for individuals of varying ages (with and without mTBI) and in military personnel who have undergone 26 hours of sleep deprivation.
Testing will be conducted at two sites:
- Civilians with mTBI; and civilians with adult attention deficit hyperactivity disorder will be tested by trained staff of the Brain Trauma Foundation (BTF) at Weill Cornell Medical College (WCMC) in New York City. The ages of the enrolled individuals will range between 18-55 years in order to examine aging effects.
- Enrolled service members will be tested at the United States Army Research Institute of Environmental Medicine (USARIEM) in Natick, Massachusetts. These service members will be healthy volunteers without a history of mTBI. Some of these subjects will undergo 26 hours of sleep deprivation during which they will be tested at specific time points.
Our objectives are:
- Prove that the eye-tracking concept can be brought from a successful laboratory device to a specific, reliable, selective, and valid diagnostic tool.
1.1. Test reliability by examining the test-retest reliability measures of EYE-TRAC;
1.2. Test selectivity by testing the ability to differentiating the effects of fatigue, aging, and mTBI on EYE-TRAC measures;
1.3. Test validity by determining the relationship between measures of attention and working memory based on the EYE-TRAC and validated measures of sustained attention and working memory;
1.4. Test specificity by measuring the spectrum of TBI injury using MRI-DTI and correlate with EYE-TRAC.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI Patients | – | –Individuals who have suffered a mild traumatic brain injury and have persistent post-concussive symptoms (PCS) |
| Normals | – | –Individuals of comparable age and education who have not suffered a traumatic brain injury |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- TBI patients will be recruited from an outpatient TBI clinic Normals will be friends/family of TBI patients who have not suffered a TBI, as well as individuals recruited from the community
Key inclusion criteria (4 listed)
- Healthy volunteer
- Education up to 12th grade
- Education up to 12th grade
- Persistent post concussive symptoms after an isolated incident of head injury with or without loss of consciousness between 3 months to 5 years prior to participation
Key exclusion criteria (11 listed)
- History of concussion or TBI
- Alcohol or substance abuse problems, neurological disorders, major psychiatric disorders (including ADHD or PTSD)
- Gross visual or hearing problems
- Pregnancy
- Metal in the body or any contraindications for MRI
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
Not reported in the source record.
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 May 2014.
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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.
Jamshid Ghajar, M.D., Ph.D. principal investigator
Brain Trauma Foundation
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 Post Concussive Syndrome, Chronic, run by Brain Trauma Foundation 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 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 May 2014. 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.
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 May 2014.