Brain Concussion Clinical Trial in Washington DC
NCT00724607
| Observational
This study is looking to recruit 300 Participants
Many active duty military, national guard, and reserves personnel who served in the recent
conflicts in Afghanistan and Iraq were exposed to blasts and other mechanisms of traumatic
brain injury (TBI).1,2 Although physical trauma is not unexpected during war fighting,
survival after head injury, particularly blast-related, has become a common occurrence only
in recent decades. As such, the associated cerebral damage is less well studied and
understood, particularly over the long term.
The Brain Injury Outcomes (BIO) is a longitudinal study with the short-term objective of
better characterizing multi-modal outcomes in individuals who have sustained a brain injury
using a systems medicine approach. Long-term aims include monitoring participants for signs
of emerging symptoms or age-related vulnerabilities. Identification of abnormality profiles
for multiple severity levels of brain injury (from any source, including blast and non-blast)
reflects a second long-range goal. Third, the investigators will examine and compare
physiology between Veterans who have sustained a Mild Traumatic Brain Injury (mTBI) with and
without persisting symptoms and various co-morbidities including posttraumatic stress
disorder (PTSD) and depression. A control group of Veterans who have not sustained a TBI will
also be recruited for comparison. Fourth, the investigators intend to facilitate the clinical
use of advanced methodologies, such as brain imaging measures, with the brain injured (and
other populations). Finally, the investigators will assess methods of analysis, separately
and in combination through integration, for multi-modal data in search of diagnostic
profiles. Increased knowledge of injury patterns and the trajectory associated with brain
injury could contribute to better methods of diagnosis, monitoring and, perhaps, treatment.
This investigation has spawned several sub-studies, one of which was the Validation of Brief
Objective Neurobehavioral Detectors (BOND) of Mild TBI, which continues. The investigators
have collaborated with Harvard/Boston Children's Hospital in the Angiogenic Signaling
Signatures Identified in Stress and Trauma (ASSIST) sub-study. Oak Ridge National Laboratory
(ORNL) will assist in integrating BIO Study multi-modal data. Investigators at Johns Hopkins
School of Medicine collaborate with neuroimaging sequences and methods.
Details for the study
Population
OEF/OIF/OND Veterans with and without mTBI and/or PTSD
Brief Title
Brain Injury Outcomes (BIO) Study
Official Title
Validation of Brief Objective Neurobehavioral Detectors of Mild TBI
Brief Summary
Many active duty military, national guard, and reserves personnel who served in the recent
<br /> conflicts in Afghanistan and Iraq were exposed to blasts and other mechanisms of traumatic
<br /> brain injury (TBI).1,2 Although physical trauma is not unexpected during war fighting,
<br /> survival after head injury, particularly blast-related, has become a common occurrence only
<br /> in recent decades. As such, the associated cerebral damage is less well studied and
<br /> understood, particularly over the long term.
<br />
<br /> The Brain Injury Outcomes (BIO) is a longitudinal study with the short-term objective of
<br /> better characterizing multi-modal outcomes in individuals who have sustained a brain injury
<br /> using a systems medicine approach. Long-term aims include monitoring participants for signs
<br /> of emerging symptoms or age-related vulnerabilities. Identification of abnormality profiles
<br /> for multiple severity levels of brain injury (from any source, including blast and non-blast)
<br /> reflects a second long-range goal. Third, the investigators will examine and compare
<br /> physiology between Veterans who have sustained a Mild Traumatic Brain Injury (mTBI) with and
<br /> without persisting symptoms and various co-morbidities including posttraumatic stress
<br /> disorder (PTSD) and depression. A control group of Veterans who have not sustained a TBI will
<br /> also be recruited for comparison. Fourth, the investigators intend to facilitate the clinical
<br /> use of advanced methodologies, such as brain imaging measures, with the brain injured (and
<br /> other populations). Finally, the investigators will assess methods of analysis, separately
<br /> and in combination through integration, for multi-modal data in search of diagnostic
<br /> profiles. Increased knowledge of injury patterns and the trajectory associated with brain
<br /> injury could contribute to better methods of diagnosis, monitoring and, perhaps, treatment.
<br />
<br /> This investigation has spawned several sub-studies, one of which was the Validation of Brief
<br /> Objective Neurobehavioral Detectors (BOND) of Mild TBI, which continues. The investigators
<br /> have collaborated with Harvard/Boston Children's Hospital in the Angiogenic Signaling
<br /> Signatures Identified in Stress and Trauma (ASSIST) sub-study. Oak Ridge National Laboratory
<br /> (ORNL) will assist in integrating BIO Study multi-modal data. Investigators at Johns Hopkins
<br /> School of Medicine collaborate with neuroimaging sequences and methods.
Detailed Description
This study was previously paused due to the pandemic.
Many active duty military, national guard, and reserves personnel who served in the recent
conflicts in Afghanistan and Iraq were exposed to blasts and other mechanisms of traumatic
brain injury (TBI).1,2 Although physical trauma is not unexpected during war fighting,
survival after head injury, particularly blast-related, has become a common occurrence only
in recent decades. As such, the associated cerebral damage is less well studied and
understood, particularly over the long term.
The Brain Injury Outcomes (BIO) is a longitudinal study with the short-term objective of
better characterizing multi-modal outcomes in individuals who have sustained a brain injury
using a systems medicine approach. Long-term aims include monitoring participants for signs
of emerging symptoms or age-related vulnerabilities. Identification of abnormality profiles
for multiple severity levels of brain injury (from any source, including blast and non-blast)
reflects a second long-range goal. Third, the investigators will examine and compare
physiology between Veterans who have sustained a Mild Traumatic Brain Injury (mTBI) with and
without persisting symptoms and various co-morbidities including posttraumatic stress
disorder (PTSD) and depression. A control group of Veterans who have not sustained a TBI will
also be recruited for comparison. Fourth, the investigators intend to facilitate the clinical
use of advanced methodologies, such as brain imaging measures, with the brain injured (and
other populations). Finally, the investigators will assess methods of analysis, separately
and in combination through integration, for multi-modal data in search of diagnostic
profiles. Increased knowledge of injury patterns and the trajectory associated with brain
injury could contribute to better methods of diagnosis, monitoring and, perhaps, treatment.
This investigation has spawned several sub-studies, one of which was the Validation of Brief
Objective Neurobehavioral Detectors (BOND) of Mild TBI, which continues. The investigators
have collaborated with Harvard/Boston Children's Hospital in the Angiogenic Signaling
Signatures Identified in Stress and Trauma (ASSIST) sub-study. Oak Ridge National Laboratory
(ORNL) will assist in integrating BIO Study multi-modal data. Investigators at Johns Hopkins
School of Medicine collaborate with neuroimaging sequences and methods.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Fractional anisotropy (FA)
In this longitudinal study with multiple measurement modalities (i.e., neuroimaging, neurologic exam, cognition, etc.), the primary outcome measures are from the neuroimaging modality, specifically, the diffusion tensor imaging (DTI) sequences. FA is one of the quantitative metrics yielded by the DTI sequence. FA is a ratio of the directional flows of water molecules within axonal bundles and is interpreted as a representation of the overall structural health of the bundle.
Study Criteria
Inclusion Criteria:
Inclusion criteria for TBI Group (Case Group):
TBI group Veterans must:
- be enrolled at the Washington, DC VA Medical Center
- be an Operation Enduring Freedom (OEF)/ Operation Iraqi Freedom (OIF)/OND Veteran
- be between the ages of 18 and 59, inclusive
- have at least 10 years of education
- be able to fit into scanner (i.e., weigh less than 400 pounds)
- have a brain injury (based upon VHA criteria)
- be at least one year post-injury
Inclusion criteria for NonTBI Group (Control Group):
NonTBI group Veterans must:
- be enrolled at the Washington, DC VAMC
- have been active duty (whether deployed or not) during OEF and/or OIF and/or OND
- be between the ages of 18 and 59, inclusive
- have at least 10 years of education
Exclusion Criteria:
Exclusion Criteria for both the Case and Control Groups:
Veterans must NOT:
- be colorblind or have any visual impairment that interferes with reading or writing
- have any upper extremity dysfunction that prevents the use of a pencil or computer
mouse or keyboard
- meet criteria for substance dependence within 1 month of the evaluation
- have a current acute or unstable psychiatric condition
- have a current diagnosis (or symptoms consistent with) schizophrenic or bipolar
disorders, or severe uni-polar depression
- be in significant pain during the evaluation (patient subjective report)
- have a diagnosis of diabetes (PET imaging considerations)
- have had or currently have any other injury, medical or neurological illness, or
exposure that could potentially explain cognitive deficits (e.g., Central Nervous
System disease, prior brain injury, seizure disorder, or HIV)
- be taking prescription drugs that significantly interfere with outcome measures
- have any devices or material implanted, embedded, or attached to the body containing
ferrous material that interferes with MR imaging (i.e., pacemaker, shrapnel)
- Be a pregnant or lactating female (MRI considerations)
- Display behavior that would significantly interfere with validity of data collection
or safety during study