Mild Traumatic Brain InjuryNCT03777228
Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Primary Study
An observational study of Mild Traumatic Brain Injury, run by Uniformed Services University of the Health Sciences.
Trial summary
This study was conducted to develop and validate integrated eye tracking and EEG measures for assessment of mild traumatic brain injury. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2015to 15 Mar 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants will be recruited through USUHS, the Walter Reed National Military Medical Center, the National Intrepid Center of Excellence, Malcolm Grow Medical Center, the Washington DC VA Medical Center, VA outpatient treatment centers and Vet Centers in the greater Washington, D.C. area, Fort Belvoir, Fort Detrick and Fort Meade, public areas in the surrounding community, and in clinical settings such as such as concussion clinics, neurorehabilitation centers, and other local private practices.
Who may be able to join
- age 18 -55, ability to use left and right hands and right foot to complete cognitive and motor tasks without adaptive equipment, and fluent in English
Who cannot join
- history of severe TBI, history of neurological illness unrelated to TBI, vision problems that are uncorrected by contacts or glasses, history of psychotic disorder, or current homicidal or suicidal ideation or intent
About this study
This study was conducted to develop and validate integrated eye tracking and EEG measures for assessment of mild traumatic brain injury.
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Traumatic brain injury, concussion, eye tracking, EEG, fMRI, DTI, Neurocognition
- Medical subject headings
- Brain Concussion, 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 | Individuals without traumatic brain injury | |
| Mild TBI | Individuals with mild traumatic brain injury | |
| Moderate to Severe TBI | Individual with moderate to severe traumatic brain injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saccadic RT
Saccadic Response Time
Measured: 1 day (single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start15 Apr 2015
- Primary completion15 Mar 2017
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777228
- Sponsor's protocol ID
- G172NU-S1
- Status last verified
- Jun 2017
- First submitted
- 14 Dec 2018
- Last updated
- 17 Dec 2018
- Results posted
- No
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
- Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Primary Study
- ClinicalTrials.gov ID
- NCT03777228
- Acronym / sponsor ID
- G172NU-S1
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Traumatic brain injury, concussion, eye tracking, EEG, fMRI, DTI, Neurocognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 17 Dec 2018 (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.
This study was conducted to develop and validate integrated eye tracking and EEG measures for assessment of mild traumatic brain injury.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Individuals without traumatic brain injury |
| Mild TBI | – | –Individuals with mild traumatic brain injury |
| Moderate to Severe TBI | – | –Individual with moderate to severe traumatic brain injury |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be recruited through USUHS, the Walter Reed National Military Medical Center, the National Intrepid Center of Excellence, Malcolm Grow Medical Center, the Washington DC VA Medical Center, VA outpatient treatment centers and Vet Centers in the greater Washington, D.C. area, Fort Belvoir, Fort Detrick and Fort Meade, public areas in the surrounding community, and in clinical settings such as such as concussion clinics, neurorehabilitation centers, and other local private practices.
Key inclusion criteria (1 listed)
- age 18 -55, ability to use left and right hands and right foot to complete cognitive and motor tasks without adaptive equipment, and fluent in English
Key exclusion criteria (1 listed)
- history of severe TBI, history of neurological illness unrelated to TBI, vision problems that are uncorrected by contacts or glasses, history of psychotic disorder, or current homicidal or suicidal ideation or intent
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
Saccadic RT
Time frame: 1 day (single time point)
Saccadic Response Time
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 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Traumatic Brain Injury, run by Uniformed Services University of the Health Sciences.
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 1 inclusion and 1 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 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Saccadic RT (time frame: 1 day (single time point)). 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.