Traumatic Brain Injury Clinical Trial
Official title:
ADVANCED MRI IN BLAST-RELATED TBI
Verified date | December 2014 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Thousands of soldiers, marines, and other military personnel have had injuries to the brain
due the wars in Iraq and Afghanistan. In addition, 1.5 million civilians per year in the
United States have traumatic brain injuries caused by car accidents, falls, sports-related
injuries or assaults. There are important advances in technology that we think will 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. These 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.
Our overall goal is to see whether these new MRI scans will be useful for people who have had
traumatic brain injuries. We have already tested them on some civilian brain injury patients
and found them to be very helpful. For this study, we will test them on military personnel
who have had traumatic brain injuries caused by explosions. The specific goal will be to see
if the amount of injury we see can be used to predict how well the patients will do overall
over the next 6-12 months. We think with the new scans we will be able to predict overall
outcomes better than with regular scans and other information. 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. 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.
If the study is successful, it will show that these new MRI techniques can to be used to make
earlier and more accurate diagnoses of traumatic brain injury, predictions of the sorts of
problems that are likely to occur after brain injury, and assessments of how severe the
injuries are.
This study will help traumatic brain injury patients. It will be most useful for military
personnel who have had brain injuries due to explosions. It is highly likely that it will
also be useful for younger adults who have had brain injuries due to other causes like car
accidents, sports-related concussions, falls, or assaults. It is possible that but not known
for sure whether it will help young children or older adults with traumatic brain injuries.
These new scans could help with decisions about whether military personnel can return to
duty, what sort of rehabilitation would benefit them most, and what family members should
watch for and expect. This could become used in some hospitals within 2 years, and could
become standard in every major hospital within 5 years.
The new scans could also be helpful in developing new treatments. For example, if a new drug
works by blocking injury to the axons, it would be a good idea to test on people who have
injury to their axons. Right now we have no good way to tell who these people are, and so a
new drug like this would get tested on lots of people who don't have injured axons, along
with those who do. This would make it harder to tell if the new drug is working. With the new
scans we should be able to tell who has injured axons, tell how severe the injury is, and
figure out whom to test the drugs on. It will likely take 10 years or more to develop new
drugs like this.
Further in the future, the new scans could be used to help guide surgery to implant computer
chips to help rewire the brain. We don't know how long this will take, but estimate 15-20
years or more.
Overall MRI scanning is very safe and has no known major risks. Because the scanner uses
strong magnets, anyone with metal objects in their bodies can't be scanned, as this could be
dangerous. We will make sure that no one with metal objects in their bodies is included in
the study. There can be some psychological risks involved in taking tests and answering
questions, but these are usually mild and can be managed. There is always a risk that
important confidential information will be made public and that this could have consequences.
We will do everything possible to maintain confidentiality. Nearly all of the information
will only be identified using a code number and not by the name of the person, and all of it
will be kept securely.
Status | Unknown status |
Enrollment | 100 |
Est. completion date | July 2016 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Clinical diagnosis of blast-related TBI of any severity, as made by LRMC staff, based on clinical history, examination, and/or standard clinical imaging (CT, conventional MRI). 2. Acute injury or injuries, defined as first occurring 0-90 days prior to enrollment. 3. 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. 4. No known metallic implants or metallic foreign objects. 5. Ability to provide informed consent. 6. Not known to be HIV positive 7. Not known to be pregnant 8. No previous major traumatic brain injury 9. No contraindication to MRI for medical reasons such as arrhythmias. |
Country | Name | City | State |
---|---|---|---|
Germany | Landstuhl Regional Medical Center | Landstuhl | Kirchberg |
United States | Washington University | St Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Landstuhl Regional Medical Center, U.S. Army Medical Research and Materiel Command |
United States, Germany,
Han K, Mac Donald CL, Johnson AM, Barnes Y, Wierzechowski L, Zonies D, Oh J, Flaherty S, Fang R, Raichle ME, Brody DL. Disrupted modular organization of resting-state cortical functional connectivity in U.S. military personnel following concussive 'mild' — View Citation
Mac Donald C, Johnson A, Cooper D, Malone T, Sorrell J, Shimony J, Parsons M, Snyder A, Raichle M, Fang R, Flaherty S, Russell M, Brody DL. Cerebellar white matter abnormalities following primary blast injury in US military personnel. PLoS One. 2013;8(2): — View Citation
Mac Donald CL, Johnson AM, Cooper D, Nelson EC, Werner NJ, Shimony JS, Snyder AZ, Raichle ME, Witherow JR, Fang R, Flaherty SF, Brody DL. Detection of blast-related traumatic brain injury in U.S. military personnel. N Engl J Med. 2011 Jun 2;364(22):2091-1 — View Citation
MacDonald CL, Johnson AM, Nelson EC, Werner NJ, Fang R, Flaherty SF, Brody DL. Functional status after blast-plus-impact complex concussive traumatic brain injury in evacuated United States military personnel. J Neurotrauma. 2014 May 15;31(10):889-98. doi — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the overall extent of abnormalities apparent on DTI vs conventional MRI. | 1 year | ||
Primary | Identification of specific injured white matter tracts. | 1 year | ||
Primary | Assessment of the correlations in fMRI signal fluctuations between brain regions. | 1 year | ||
Primary | Prediction of the 6-12 month global clinical outcome (GOS-E) based on the acutely apparent DTI abnormalities. | 1 year | ||
Primary | Prediction of the 6-12 month global clinical outcome (GOS-E) based on the acutely apparent resting fMRI correlation abnormalities. | 1 year | ||
Primary | Prediction of the presence and clinical severity of specific post-traumatic sequelae, including i. Spastic hemi/tetraparesis:ii. Short-term learning and memory deficits:iii. Attention deficit:iv. Depression:v. Post-traumatic stress disorder: | 1 year | ||
Primary | Comparison of acute and 6-12 month scans. | 1 year | ||
Primary | Evaluation of the predictive value of the Military Acute Concussion Evaluation (MACE) | 1 year |
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