Identifying Biomarkers That Distinguish PTSD and mTBI Using Advanced Magnetic Resonance Spectroscopy



Status:Completed
Conditions:Neurology, Psychiatric, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:1/20/2018
Start Date:January 2012
End Date:September 2017

Use our guide to learn which trials are right for you!

Identifying Biomarkers That Distinguish Post-Traumatic Stress Disorder and Mild Traumatic Brain Injury Using Advanced Magnetic Resonance Spectroscopy

The purpose of this study is to develop a new test to help diagnose mild traumatic brain
injury (mTBI) and post-traumatic stress disorder (PTSD) in soldiers. Chemicals in the brain
will be measured using a Magnetic Resonance Spectroscopy (MRS) scan. In the study, the
investigators will compare the information they obtain from scans of participants with mTBI,
PTSD or both, to scans from healthy volunteers to understand the differences between these
groups. If the results can tell the difference between participants with mTBI and PTSD, the
investigators should be able to help safely diagnose patients in the future.

Soldiers from the US Army, with well characterized diagnosis of mTBI or PTSD, will be
recruited in the first year as will age-matched healthy controls from the military and
civilian populations. MRI, single voxel MRS, and two-dimensional correlated spectroscopy (2D
COSY) MRS will be acquired from each participant at the Brigham and Women's Hospital (BWH).
This data will be anonymized and transferred to the Draper Laboratories. Biomarkers for each
disease will be identified by comparison with control data. These biomarkers will then be fed
into classifiers that will then be validated with a similar cohort acquired in the second
year. The second cohort of subjects will then be incorporated into the classifier algorithms
for a stronger and more robust classification from which a diagnostic test will emerge. To
test this diagnostic evaluation the data analysis by both BWH and Draper labs will be blinded
to the characterization of the participants and from the MRS results, the investigators will
predict if the participant has mTBI, PTSD, both, or neither. Finally, all data will then be
fused into the algorithms to provide a final classifier. The results of the final classifier
will then be correlated with clinical, neuropsychological, and neuroanatomical indices of
mTBI and PTSD. These correlations will provide the most complete biochemical analysis of mTBI
and PTSD which may lead to insight into alternate pathways for drug development.

Inclusion Criteria:

1. Between the ages of 18 and 55

2. Male and female

3. High School diploma or General Educational Development (GED) equivalent

Exclusion Criteria:

1. History of brain tumor, epilepsy, dementia, and other neurological disorders

2. History of psychotic, bipolar, or other mental disorder aside from PTSD

3. Substance abuse and/or use within the past month of skeletal muscle relaxants,
narcotics, anticonvulsants, neuroleptics, benzodiazepines, cerebral stimulants,
sedatives, or hypnotics during the month prior to testing, or a "dirty" urine specimen
(i.e., containing amphetamines, barbiturates, cocaine, opiates, benzodiazepines,
methaqualone, propoxyphene, phencyclidine, methadone, or cannabinoids)

4. Alcohol use 24 hours prior to testing. Subjects will be asked to abstain 24 hours in
advance as alcohol can be detected in the MRS spectrum as a multiplet at 1.5 ppm.

5. Inability to give informed consent for participation

6. Any contraindications for MR imaging and spectroscopy

1. electrical implants such as cardiac pacemakers or perfusion pumps

2. ferromagnetic implants such as aneurysm clips, surgical clips, prostheses,
artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos
near the eye, or steel implants

3. ferromagnetic objects such as jewelry or metal clips in clothing

4. any greater than normal potential for cardiac arrest

5. pregnancy (female of childbearing age and are still having your menstrual periods
will be asked to give a urine sample for a pregnancy test that will be
administered by the technologist).
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials