Advanced MRI in Blast-related TBI

NCT00785304 | Unknown DMC

• 1 other identifier: PT075299
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (8)

• Comparison of the overall extent of abnormalities apparent on DTI vs conventional MRI.

  1 year

• Identification of specific injured white matter tracts.

  1 year

• Assessment of the correlations in fMRI signal fluctuations between brain regions.

  1 year

• Prediction of the 6-12 month global clinical outcome (GOS-E) based on the acutely apparent DTI abnormalities.

  1 year

• Prediction of the 6-12 month global clinical outcome (GOS-E) based on the acutely apparent resting fMRI correlation abnormalities.

  1 year

• 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

• Comparison of acute and 6-12 month scans.

  1 year

• Evaluation of the predictive value of the Military Acute Concussion Evaluation (MACE)

  1 year

Study Arms (2)

Traumatic Brain Injury

Active Duty military blast-related TBI patients

Other Injury Control

Active duty military patients with other injuries but no TBI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Active duty military personnel serving in Iraq, Afghanistan, and other areas presenting to Landstuhl Regional Medical Center for care.

You may qualify if:

• 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).
• Acute injury or injuries, defined as first occurring 0-90 days prior to enrollment.
• 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.
• No known metallic implants or metallic foreign objects.
• Ability to provide informed consent.
• Not known to be HIV positive
• Not known to be pregnant
• No previous major traumatic brain injury
• No contraindication to MRI for medical reasons such as arrhythmias.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Landstuhl Regional Medical Center: collaborator
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (2)

Washington University

St Louis, Missouri, 63110, United States

Location

Landstuhl Regional Medical Center

Landstuhl, Kirchberg, 66849, Germany

Location

Related Publications (4)

• 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):2091-100. doi: 10.1056/NEJMoa1008069.

  PMID: 21631321 RESULT

• 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):e55823. doi: 10.1371/journal.pone.0055823. Epub 2013 Feb 7.

  PMID: 23409052 RESULT

• 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' blast-related traumatic brain injury. Neuroimage. 2014 Jan 1;84:76-96. doi: 10.1016/j.neuroimage.2013.08.017. Epub 2013 Aug 20.

  PMID: 23968735 RESULT

• 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: 10.1089/neu.2013.3173. Epub 2014 Feb 10.

  PMID: 24367929 RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• David L Brody, MD PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: November 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2016
• Last Updated: December 10, 2014

Record last verified: 2014-12

Locations

DE (1); US (1)