Posttraumatic Stress DisorderNCT01547819
Mild Traumatic Brain Injury and Post-Traumatic Stress Disorder
An observational study of Posttraumatic Stress Disorder and Traumatic Brain Injury, run by National Institutes of Health Clinical Center (CC).
Trial summary
Background: Some people who have a traumatic brain injury (TBI) recover completely. Others, however, develop post-traumatic stress disorder (PTSD), with anxiety and depression. Research suggests that levels of a brain chemical called GABA may differ in people with PTSD compared to those without PTSD. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Traumatic Brain Injury
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 Feb 2012to 18 Dec 2013
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- TBI-PTSD SUBJECTS:
- Subjects in this group must meet the following inclusion criteria:
- Documented diagnosis of non-penetrating mTBI within the last two years.
- Diagnosis of PTSD (which is known to have occurred following the mTBI event) as per the diagnostic criteria followed by protocol number NNMC.2011.0035 at WRNMMC
- Age 18-50 years of age
- TBI-no PTSD SUBJECTS:
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- Subjects in this group must meet the following inclusion criteria:
- No history of PTSD or other major psychiatric disorders
- Mild TBI diagnosis.
- Age 18-50 years of age
- PTSD-no TBI subjects:
- Subjects in this group must meet the following inclusion criteria:
- No history of TBI
- PTSD diagnosis as per the diagnostic criteria followed by protocol number NNMC.2011.0035 at WRNMMC.
- Age 18-50 years of age
- Healthy Control subjects:
- Subjects in this group must meet the following inclusion criteria:
- No history of penetrating or non-penetrating head trauma.
- Exclusion of PTSD or other serious psychiatric disorders by psychiatric evaluation as per the diagnostic criteria followed by protocol number NNMC.2011.0035 at WRNMMC
- Age 18-50 years of age
Who cannot join
- All Subjects:
- Subjects are not eligible for participation in this research study if any of the following conditions exist:
- Subjects with history of strokes, brain tumors, seizure and other neurologic problems
- Subjects with serious medical illness such as heart disease, lung disease, kidney disease, a blood disorder like multiple myeloma, diabetes or blood vessel disease.
- Contraindication(s) to MRI scanning, including pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments, morbid obesity and severe claustrophobia).
- Pregnant women or women who are breast-feeding.
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- History of taking anxiolytics (namely benzodiazepines and barbiturates), anti-depressants or anti-psychotic drugs, unless abstinence for at least 4 weeks prior to the scan.
- History of taking GABAergic drugs such as gabapentin, vigabatrin, tiagabine, lamotrigine, pregabalin and others unless abstinence for at least 4 weeks prior to the scan.
- Blood alcohol concentration >0.0 using a breathalyzer on the day of the scan.
- Evidence of heavy alcohol use based on AUDIT questionnaire (score >8)
- Evidence of drug dependence based on the urine toxicology screen.
- History of previous radiation exposure from any source that, when combined with PET/CT scan, would exceed NIH RSC limits.
- Lifetime or current diagnosis of schizophrenia or other psychotic disorder, or bipolar disorder
- Subjects who cannot give their own consent.
About this study
Official title: Imaging the GABAergic System Using 11C-flumazenil PET to Assess the Role of Mild Traumatic Brain Injury in the Development of Post Traumatic Stress Disorder
Background:
- Some people who have a traumatic brain injury (TBI) recover completely. Others, however, develop post-traumatic stress disorder (PTSD), with anxiety and depression. Research suggests that levels of a brain chemical called GABA may differ in people with PTSD compared to those without PTSD. Researchers want to see if TBI can affect GABA in the brain and help develop PTSD. To look at the brain, researchers will use imaging studies with the chemical 11C-Flumazenil, which will help the scan show GABA levels in the brain.
Read more
Objectives:
- To study the relationship between PTSD and TBI.
Eligibility:
The subjects will be recruited from the Walter Reed National Military Medical Center (WRNMMC).
- Individuals between 18 and 50 years of age who have PTSD and/or had a mild TBI.
- Healthy individuals between 18 and 50 years of age who have no history TBI and no history of PTSD.
Design:
- Participants will be screened with a physical exam and medical history. Urine and breath samples will also be collected.
- Participants will have two imaging studies, on the same day if possible. The first will be a magnetic resonance imaging scan to look at the brain. The second will be a positron emission tomography scan with the study chemical to look at GABA pathways in the brain....
Read the detailed description
Objective
The primary objective of this study is to investigate the potential role of mild traumatic brain injury (mTBI) in the development of post-traumatic stress disorder (PTSD). We will characterize the central GABAergic system function in patients with PTSD after TBI (TBI-PTSD), subjects with TBI only (TBI-no PTSD), subjects with PTSD only (PTSD-no TBI ), and healthy non-TBI non-PTSD subjects (HC), using PET imaging with (11)C-Flumazenil (FMZ). Our hypothesis is that neuronal and axonal damage due to TBI results in GABAergic system dysfunction which could potentially lead to or contribute to the development of PTSD. We will also correlate the degree of (11)C-FMZ binding abnormalities with time elapsed since the original physical or psychological trauma in TBI-PTSD and PTSD-no TBI patients.
Study Population
Fifty-six male and female adult subjects will be recruited: 14 subjects with PTSD following an episode of non-penetrating mTBI (TBI-PTSD), 14 subjects with mTBI but no history of PTSD (TBI-no PTSD), 14 subjects with PTSD but no history of TBI (PTSD-no TBI), and 14 healthy volunteers (HC) with no PTSD and no history of TBI. The subjects will be recruited from the Walter Reed National Military Medical Center (WRNMMC).
Design
This is a prospective case-control study of the four subject groups mentioned above. Subjects will be stratified according to detailed psychiatric evaluation performed at WRNMMC. Subjects will not be treated with experimental therapies as part of the research study. This study will provide no direct benefit to subjects.
Outcome Measures
The main outcome measure will be (11)C-FMZ binding potential (BP) differences among these four subject groups. Other outcome measures will include Magnetic Resonance Imaging (MRI) anatomical findings and the correlation of (11)C-FMZ binding abnormalities with time elapsed since the original physical trauma in TBI-PTSD group or original psychological trauma in PTSD only group.
- Keywords
- TBI, Magnetic Resonance Imaging (MRI), PTSD, PET Imaging, 11C-Flumazenil
- Medical subject headings
- Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome measure will be (11)C-FMZ binding potential (BP) in PTSD post mTBI as compared with nTBI without PTSD and healthy control volunteers without PTSD or TBI.
Secondary outcomes (1)
Degree of correlation between 11C-FMZ BP abnormalities and time elapsed since the original physical trauma in TBI-PTSD patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study start16 Feb 2012
- Study completion18 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Uniformed Services University of the Health Sciences
- Investigators
- Dima A Hammoud, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547819
- Sponsor's protocol ID
- 120082
- Other IDs
- 12-CC-0082
- Status last verified
- 18 Dec 2013
- First submitted
- 6 Mar 2012
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Rutland-Brown W, Langlois JA, Thomas KE, Xi YL. Incidence of traumatic brain injury in the United States, 2003. J Head Trauma Rehabil. 2006 Nov-Dec;21(6):544-8. doi: 10.1097/00001199-200611000-00009.
PubMed 17122685Selassie AW, Zaloshnja E, Langlois JA, Miller T, Jones P, Steiner C. Incidence of long-term disability following traumatic brain injury hospitalization, United States, 2003. J Head Trauma Rehabil. 2008 Mar-Apr;23(2):123-31. doi: 10.1097/01.HTR.0000314531.30401.39.
PubMed 18362766Zaloshnja E, Miller T, Langlois JA, Selassie AW. Prevalence of long-term disability from traumatic brain injury in the civilian population of the United States, 2005. J Head Trauma Rehabil. 2008 Nov-Dec;23(6):394-400. doi: 10.1097/01.HTR.0000341435.52004.ac.
PubMed 19033832
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging the GABAergic System Using 11C-flumazenil PET to Assess the Role of Mild Traumatic Brain Injury in the Development of Post Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01547819
- Acronym / sponsor ID
- 120082
- Keywords
- TBI, Magnetic Resonance Imaging (MRI), PTSD, PET Imaging, 11C-Flumazenil
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- Uniformed Services University of the Health Sciences
- Study start
- 16 Feb 2012
- Study completion
- 18 Dec 2013
- First posted
- 8 Mar 2012 (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.
Background:
- Some people who have a traumatic brain injury (TBI) recover completely. Others, however, develop post-traumatic stress disorder (PTSD), with anxiety and depression. Research suggests that levels of a brain chemical called GABA may differ in people with PTSD compared to those without PTSD. Researchers want to see if TBI can affect GABA in the brain and help develop PTSD. To look at the brain, researchers will use imaging studies with the chemical 11C-Flumazenil, which will help the scan show GABA levels in the brain.
Objectives:
- To study the relationship between PTSD and TBI.
Eligibility:
The subjects will be recruited from the Walter Reed National Military Medical Center (WRNMMC).
- Individuals between 18 and 50 years of age who have PTSD and/or had a mild TBI.
- Healthy individuals between 18 and 50 years of age who have no history TBI and no history of PTSD.
Design:
- Participants will be screened with a physical exam and medical history. Urine and breath samples will also be collected.
- Participants will have two imaging studies, on the same day if possible. The first will be a magnetic resonance imaging scan to look at the brain. The second will be a positron emission tomography scan with the study chemical to look at GABA pathways in the brain....
Detailed description
Objective
The primary objective of this study is to investigate the potential role of mild traumatic brain injury (mTBI) in the development of post-traumatic stress disorder (PTSD). We will characterize the central GABAergic system function in patients with PTSD after TBI (TBI-PTSD), subjects with TBI only (TBI-no PTSD), subjects with PTSD only (PTSD-no TBI ), and healthy non-TBI non-PTSD subjects (HC), using PET imaging with (11)C-Flumazenil (FMZ). Our hypothesis is that neuronal and axonal damage due to TBI results in GABAergic system dysfunction which could potentially lead to or contribute to the development of PTSD. We will also correlate the degree of (11)C-FMZ binding abnormalities with time elapsed since the original physical or psychological trauma in TBI-PTSD and PTSD-no TBI patients.
Study Population
Fifty-six male and female adult subjects will be recruited: 14 subjects with PTSD following an episode of non-penetrating mTBI (TBI-PTSD), 14 subjects with mTBI but no history of PTSD (TBI-no PTSD), 14 subjects with PTSD but no history of TBI (PTSD-no TBI), and 14 healthy volunteers (HC) with no PTSD and no history of TBI. The subjects will be recruited from the Walter Reed National Military Medical Center (WRNMMC).
Design
This is a prospective case-control study of the four subject groups mentioned above. Subjects will be stratified according to detailed psychiatric evaluation performed at WRNMMC. Subjects will not be treated with experimental therapies as part of the research study. This study will provide no direct benefit to subjects.
Outcome Measures
The main outcome measure will be (11)C-FMZ binding potential (BP) differences among these four subject groups. Other outcome measures will include Magnetic Resonance Imaging (MRI) anatomical findings and the correlation of (11)C-FMZ binding abnormalities with time elapsed since the original physical trauma in TBI-PTSD group or original psychological trauma in PTSD only group.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Documented diagnosis of non-penetrating mTBI within the last two years.
- Diagnosis of PTSD (which is known to have occurred following the mTBI event) as per the diagnostic criteria followed by protocol number NNMC.2011.0035 at WRNMMC
- Age 18-50 years of age
- No history of PTSD or other major psychiatric disorders
- Mild TBI diagnosis.
Key exclusion criteria (14 listed)
- Subjects are not eligible for participation in this research study if any of the following conditions exist:
- Subjects with history of strokes, brain tumors, seizure and other neurologic problems
- Subjects with serious medical illness such as heart disease, lung disease, kidney disease, a blood disorder like multiple myeloma, diabetes or blood vessel disease.
- Contraindication(s) to MRI scanning, including pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments, morbid obesity and severe claustrophobia).
- Pregnant women or women who are breast-feeding.
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
The main outcome measure will be (11)C-FMZ binding potential (BP) in PTSD post mTBI as compared with nTBI without PTSD and healthy control volunteers without PTSD or TBI.
1 secondary outcome
Degree of correlation between 11C-FMZ BP abnormalities and time elapsed since the original physical trauma in TBI-PTSD patients.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 17122685Rutland-Brown W, Langlois JA, Thomas KE, Xi YL. Incidence of traumatic brain injury in the United States, 2003. J Head Trauma Rehabil. 2006 Nov-Dec;21(6):544-8. doi: 10.1097/00001199-200611000-00009.
- Background: PubMed 18362766Selassie AW, Zaloshnja E, Langlois JA, Miller T, Jones P, Steiner C. Incidence of long-term disability following traumatic brain injury hospitalization, United States, 2003. J Head Trauma Rehabil. 2008 Mar-Apr;23(2):123-31. doi: 10.1097/01.HTR.0000314531.30401.39.
- Background: PubMed 19033832Zaloshnja E, Miller T, Langlois JA, Selassie AW. Prevalence of long-term disability from traumatic brain injury in the civilian population of the United States, 2005. J Head Trauma Rehabil. 2008 Nov-Dec;23(6):394-400. doi: 10.1097/01.HTR.0000341435.52004.ac.
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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.
Dima A Hammoud, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
Questions about this trial
What is this clinical trial studying?
An observational study of Posttraumatic Stress Disorder and Traumatic Brain Injury, run by National Institutes of Health Clinical Center (CC).
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 20 inclusion and 14 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: withdrawn, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The main outcome measure will be (11)C-FMZ binding potential (BP) in PTSD post mTBI as compared with nTBI without PTSD and healthy control volunteers without PTSD or TBI.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01547819, which also lists 3 linked publications.
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 17 Dec 2019.