Post-Traumatic Stress DisordersNCT02927288
Identifying Biomarkers That Distinguish PTSD and mTBI Using Advanced Magnetic Resonance Spectroscopy
An observational study of Post-Traumatic Stress Disorders and Brain Injuries, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorders, Brain Injuries
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Between the ages of 18 and 55
- Male and female
- High School diploma or General Educational Development (GED) equivalent
Who cannot join
- History of brain tumor, epilepsy, dementia, and other neurological disorders
- History of psychotic, bipolar, or other mental disorder aside from PTSD
- 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)
- 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.
- Inability to give informed consent for participation
- Any contraindications for MR imaging and spectroscopy
Show all 11Show fewer
- electrical implants such as cardiac pacemakers or perfusion pumps
- 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
- ferromagnetic objects such as jewelry or metal clips in clothing
- any greater than normal potential for cardiac arrest
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-Traumatic Stress Disorders, Brain Injuries
- Keywords
- PTSD, mTBI
- Medical subject headings
- Stress Disorders, Post-Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NAA to Creatine (NAA/Cr) Ratio (no units)
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startJan 2012
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisordersStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United States Army Research Institute of Environmental Medicine
- Responsible party
- Principal investigator, Lin, Alexander P.,Ph.D., Brigham and Women's Hospital
- Investigators
- Alexander Lin, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927288
- Sponsor's protocol ID
- W81XWH-10-1-0785
- Status last verified
- Jan 2018
- First submitted
- 30 Sep 2016
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data may be uploaded to FITBIR in the future.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Biomarkers That Distinguish Post-Traumatic Stress Disorder and Mild Traumatic Brain Injury Using Advanced Magnetic Resonance Spectroscopy
- ClinicalTrials.gov ID
- NCT02927288
- Acronym / sponsor ID
- W81XWH-10-1-0785
- Conditions
- Post-Traumatic Stress Disorders, Brain Injuries
- Keywords
- PTSD, mTBI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- United States Army Research Institute of Environmental Medicine
- Study start
- Jan 2012 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 7 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Between the ages of 18 and 55
- Male and female
- High School diploma or General Educational Development (GED) equivalent
Key exclusion criteria (11 listed)
- History of brain tumor, epilepsy, dementia, and other neurological disorders
- History of psychotic, bipolar, or other mental disorder aside from PTSD
- 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)
- 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.
- Inability to give informed consent for participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Individual participant dataSharing planned: No. Data may be uploaded to FITBIR in the future.
Related trials for Post-Traumatic Stress Disorders
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Lin, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Traumatic Stress Disorders and Brain Injuries, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NAA to Creatine (NAA/Cr) Ratio (no units) (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.