Trial record 45 of 638 for:    Alexander Disease

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02927288
Recruitment Status : Completed
First Posted : October 7, 2016
Last Update Posted : January 18, 2018
United States Army Research Institute of Environmental Medicine
Information provided by (Responsible Party):
Lin, Alexander P.,Ph.D., Brigham and Women's Hospital

Brief Summary:
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.

Condition or disease
Post-Traumatic Stress Disorders Brain Injuries

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identifying Biomarkers That Distinguish Post-Traumatic Stress Disorder and Mild Traumatic Brain Injury Using Advanced Magnetic Resonance Spectroscopy
Actual Study Start Date : January 2012
Primary Completion Date : September 2017
Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Military subjects with mTBI
mTBI/concussion only Group: Participants must have been clinically diagnosed with mTBI/concussion according to criteria outline by the World Health Organization (WHO; Holm et al., 2005) and be at least three month post-injury. Participants in the mTBI/concussion only group must not have a concurrent diagnosis of PTSD and must score below 25 on the Post-traumatic stress Check List for Civilians (PCL-C).
Military subjects with PTSD
Participants in the PTSD only group must have a clinical diagnosis of PTSD, following criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV TR). Proof of diagnosis will be obtained from participants via a request for release of pertinent medical records. Participants in this group must not have a history of mTBI or concussion.
Military subjects with mTBI and PTSD
Participants in the mixed group must meet criteria for mTBI/concussion and PTSD as outlined above.
Military healthy control
Participants in the military control group will meet all general requirements for participation but will not have a history of either mTBI/concussion or PTSD, as described above. Participants in this group will include service members on Active Duty and those currently serving with National Guard or Reserve forces.
Civilian healthy control
Participants in the civilian control group will meet all general requirements for participation but will not have a history of either mTBI/concussion or PTSD, as described above.

Primary Outcome Measures :
  1. NAA to Creatine (NAA/Cr) Ratio (no units) [ Time Frame: One year ]

    NAA/Cr ratio is a neuronal marker. The average of NAA/Cr ratios for all five groups are the following:

    civilian control 1.37 military control 1.38 military TBI 1.33 military PTSD 1.34 military mTBI and PTSD 1.42

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A total of 330 men and women from the Massachusetts National Guard, Active Duty Army, and veterans in the New England area and Brigham and Women's Hospital, Boston as well as healthy military and civilians will take part in this study.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02927288

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
United States Army Research Institute of Environmental Medicine
Principal Investigator: Alexander Lin, PhD Brigham and Women's Hospital

Responsible Party: Lin, Alexander P.,Ph.D., Director of the Center for Clinical Spectroscopy, Brigham and Women's Hospital Identifier: NCT02927288     History of Changes
Other Study ID Numbers: W81XWH-10-1-0785
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data may be uploaded to FITBIR in the future.

Keywords provided by Lin, Alexander P.,Ph.D., Brigham and Women's Hospital:

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma and Stressor Related Disorders
Mental Disorders
Brain Injuries
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries