Identifying Biomarkers That Distinguish PTSD and mTBI Using Advanced Magnetic Resonance Spectroscopy
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|ClinicalTrials.gov Identifier: NCT02927288|
Recruitment Status : Completed
First Posted : October 7, 2016
Last Update Posted : January 18, 2018
|Condition or disease|
|Post-Traumatic Stress Disorders Brain Injuries|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|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|
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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT02927288
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Alexander Lin, PhD||Brigham and Women's Hospital|