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Traumatic Brain InjuryNCT01313130

Advanced MRI In Acute Military TBI

An observational study of Traumatic Brain Injury, run by Washington University School of Medicine at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Traumatic brain injury can cause permanent problems with thinking, memory, control of emotions, organization and planning. Thousands of soldiers, marines, and other military personnel have had injuries to the brain due the wars in Iraq and Afghanistan. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Traumatic Brain Injury
How many people
400 participants
Where
2 sitesin 2 countries
Study dates
Oct 2010to Aug 2016
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
  • No healthy volunteers
  • Adult, Older adult

Study population: active duty United States military personnel

Who may be able to join

  • Clinical diagnosis of blast-related TBI of any severity, as made by the LRMC TBI screening team, based on clinical history, examination, and/or clinical imaging performed as part of standard care (CT, conventional MRI). This includes participants with both primary blast and additional mechanisms of injury ("blast-plus" injury)
  • Acute injury or injuries, defined as first occurring 0-30 days prior to enrollment.
  • Ability to provide informed consent.
  • Ability to lie still in a supine position for the duration of the scan sessions, e.g. no severe claustrophobia or limiting pain from other injuries.

Who cannot join

  • known metallic implants or metallic foreign objects.
  • known to be HIV positive
  • known to be pregnant
  • previous major traumatic brain injury
  • contraindication to MRI for medical reasons such as arrhythmias

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site
  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

Germany1 site
  • Landstuhl Regional Medical Center

    Landstuhl

Other trials in Germany

About this study

Official title: ADVANCED MRI IN ACUTE MILITARY TBI

Traumatic brain injury can cause permanent problems with thinking, memory, control of emotions, organization and planning. Thousands of soldiers, marines, and other military personnel have had injuries to the brain due the wars in Iraq and Afghanistan. Very large numbers of civilians, up to perhaps 1.5 million people per year, in the United States also have traumatic brain injuries caused by car accidents, falls, sports-related injuries or assault.

We don't know very much about traumatic brain injuries right now, but there are some important new advances in technology that may help us learn a lot more about these injuries. One such advance involves new types of MRI scans that we think will be able to show what has happened to the brain after trauma more clearly that regular scans can. The first new scan is called diffusion tensor imaging, which shows injury to the axons (the wiring of the brain). The second new scan is called resting-state functional MRI correlation analysis, which shows how well various parts of the brain are connected to each other. Importantly, the new types of scans can be done using regular scanners that we already have in every major hospital. The innovation is entirely in how the scanners are used and how the resulting pictures are analyzed on a computer after they have been taken. We have already tested these scans on some military and civilian patients with brain injury and found them to be very helpful so far. Our overall goal is to see whether these new MRI scans will be useful for active duty military personnel who have had recent traumatic brain injuries. The most important goal will be to see if the amount of injury shown on the scans be used to predict how well the patients will do overall over the next 6-12 months. A related goal will be to see whether injuries to specific parts of the brain seen by these new scans can be used to predict whether patients will be likely to have specific problems like memory loss, attention deficit, depression, or post-traumatic stress disorder. We would also like to see whether the scans could be even more useful when combined with information about genetic factors (inherited from the parents) that can be tested in the blood. Another important goal is to compare the effects of traumatic brain injuries caused by blasts or explosions with injuries from other causes, to find out what is unique about blast injury. A final goal will be to repeat the scans 6-12 months later to see whether the new MRI scans can show whether the injuries to the brain have healed, gotten worse, or stayed the same. These new scans could help with decisions about whether military personnel can return to duty, what sort of rehabilitation and treatment would benefit them most, and what family members should watch for and expect.

Keywords
traumatic brain injury, post traumatic stress disorder, Diffusion tensor imaging, resting state functional connectivity, genetic factors
Medical subject headings
Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01313130
Study groupRoleWhat they receive
blast-related TBI100 active duty US military personnel identified clinically as having suffered blast-related TBI
non-blast-related TBI100 active duty US military personnel identified clinically as having suffered non-blast-related TBI. TBI caused by other mechanisms such as motor vehicle crashes, falls, struck by blunt objects etc.
other blast-related injuries100 active duty US military personnel with blast-exposure and other blast-related injuries but no clinical evidence of TBI
other non-blast injuries100 active duty US military personnel with other non-blast injuries and no clinical evidence of TBI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive dysfunction

    Assessed by neuropsychological testing

    Measured: 6-12 months after injury

  2. Post-traumatic stress disorder

    Assessed using structured clinical interviews

    Measured: 6-12 months after injury

Secondary outcomes (2)
  1. Depression

    Assessed using structured clinical interviews

    Measured: 6-12 months after injury

  2. Neurological deficits

    Assessed using structured neurological examinations

    Measured: 6-12 months after injury

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2011 (estimated)
  2. Study startOct 2010
  3. Primary completionDec 2013
  4. Study completionAug 2016 (estimated)

Resources

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
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01313130
Sponsor's protocol ID
PT090444
Status last verified
Dec 2014
First submitted
9 Mar 2011
Last updated
10 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • Mac Donald CL, Johnson AM, Wierzechowski L, Kassner E, Stewart T, Nelson EC, Werner NJ, Zonies D, Oh J, Fang R, Brody DL. Prospectively assessed clinical outcomes in concussive blast vs nonblast traumatic brain injury among evacuated US military personnel. JAMA Neurol. 2014 Aug;71(8):994-1002. doi: 10.1001/jamaneurol.2014.1114.

    PubMed 24934200

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Brain Injury, run by Washington University School of Medicine at 2 sites in 2 countries.

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 5 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: status not confirmed, as of the sponsor's last update on 10 Dec 2014. 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, Germany. 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?

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?

Cognitive dysfunction (time frame: 6-12 months after injury). The study lists 2 primary outcomes in all. 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 NCT01313130, which also lists 1 linked publication.

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 10 Dec 2014.

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