Traumatic Brain InjuryNCT00875589
Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The study investigates whether the use of eye movement recordings can provide a reliable diagnostic of previously undiagnosed mild traumatic brain injury (blast and impact) in Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Adult betwenn 18 and 55 years old with and without a diagnosis of MTBI
Who may be able to join
- OIF/OEF Veteran;
- Neuropsych diagnosis of MTBI
Who cannot join
- chronically abusing alcohol or illicit drugs.
- uncorrected vision prevents subject from effectively viewing the stimuli, unless they can wear contact lenses during the recording session.
- inability to make normal eye movements (i.e.: saccades, smooth pursuit) required by study paradigms. Note: Deficit can be caused by taking medications that can potentially affect eye movements or any neurological condition that can interfere with making normal eye movement.
- psychological or psychiatric conditions that preclude sustained concentration or ability to perform the tasks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
About this study
Official title: Eye-movement Recordings in the Diagnosis of Traumatic Brain Injury
The study investigates whether the use of eye movement recordings can provide a reliable diagnostic of previously undiagnosed mild traumatic brain injury (blast and impact) in Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans.
Read the detailed description
Eye movements are recorded for Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans with mild traumatic brain injury (mTBI) and compared to the eye movements of those without mTBI. By analyzing and characterizing the differences between the two groups, a diagnostic measure of mTBI through the use of eye movements can be developed.
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Eye movement recording
- Medical subject headings
- Brain Injuries, Traumatic
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 |
|---|---|---|
| Control | Control subjects with no Mild Traumatic Brain Injury (MTBI) and no Post-Traumatic Stress Disorder (PTSD) | |
| MTBI | Subject with a diagnosis for Mild Traumatic Brain Injury (MTBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability of Fixation
The ability to keep eye position fixed on a visual target, measured by the distance between the target and eye fixation point averaged over 20 sec.
Measured: During eye movement recording session (20 sec).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startApr 2011
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jonathan Jacobs, PhD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875589
- Sponsor's protocol ID
- B6403-R
- Status last verified
- Oct 2015
- First submitted
- 1 Apr 2009
- Last updated
- 11 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye-movement Recordings in the Diagnosis of Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00875589
- Acronym / sponsor ID
- B6403-R
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Eye movement recording
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Posted 8 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates whether the use of eye movement recordings can provide a reliable diagnostic of previously undiagnosed mild traumatic brain injury (blast and impact) in Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans.
Detailed description
Eye movements are recorded for Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans with mild traumatic brain injury (mTBI) and compared to the eye movements of those without mTBI. By analyzing and characterizing the differences between the two groups, a diagnostic measure of mTBI through the use of eye movements can be developed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Control subjects with no Mild Traumatic Brain Injury (MTBI) and no Post-Traumatic Stress Disorder (PTSD) |
| MTBI | – | –Subject with a diagnosis for Mild Traumatic Brain Injury (MTBI) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult betwenn 18 and 55 years old with and without a diagnosis of MTBI
Key inclusion criteria (2 listed)
- OIF/OEF Veteran;
- Neuropsych diagnosis of MTBI
Key exclusion criteria (4 listed)
- chronically abusing alcohol or illicit drugs.
- uncorrected vision prevents subject from effectively viewing the stimuli, unless they can wear contact lenses during the recording session.
- inability to make normal eye movements (i.e.: saccades, smooth pursuit) required by study paradigms. Note: Deficit can be caused by taking medications that can potentially affect eye movements or any neurological condition that can interfere with making normal eye movement.
- psychological or psychiatric conditions that preclude sustained concentration or ability to perform the tasks.
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
Stability of Fixation
Time frame: During eye movement recording session (20 sec).
The ability to keep eye position fixed on a visual target, measured by the distance between the target and eye fixation point averaged over 20 sec.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jonathan Jacobs, PhD principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
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 VA Office of Research and Development 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 2 inclusion and 4 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 11 Nov 2015. 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?
Yes. Results are posted in the registry (first posted 8 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Stability of Fixation (time frame: During eye movement recording session (20 sec).). 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 11 Nov 2015.