Brain Injury Outcomes (BIO) Study
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Psychiatric, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 59 |
| Updated: | 1/17/2019 |
| Start Date: | May 6, 2008 |
| End Date: | June 30, 2020 |
| Contact: | Julie C Chapman |
| Email: | julie.chapman@va.gov |
| Phone: | (202) 745-8000 |
Validation of Brief Objective Neurobehavioral Detectors of Mild TBI
Active duty military personnel serving in the current and recent conflicts in Afghanistan and
Iraq are frequently exposed to blasts and other mechanisms of traumatic brain injury
(TBI).1,2 Although physical trauma is not unexpected during war fighting, survival after
blast-related head injury has become a common occurrence only in recent years. As such, the
associated cerebral damage is less well studied and understood.
The Brain Injury Outcomes (BIO) Study 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 all severity levels of brain injury (from any source) 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). 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 and tissue measures, with the brain injured (and other populations). Finally,
the investigators will assess methods of analysis, combination and 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
are collaborating with Harvard/Boston Children's Hospital in the Angiogenic Signaling
Signatures Identified in Stress and Trauma (ASSIST) sub-study. Oak Ridge National Laboratory
(ORNL) is integrating BIO Study multi-modal data.
Iraq are frequently exposed to blasts and other mechanisms of traumatic brain injury
(TBI).1,2 Although physical trauma is not unexpected during war fighting, survival after
blast-related head injury has become a common occurrence only in recent years. As such, the
associated cerebral damage is less well studied and understood.
The Brain Injury Outcomes (BIO) Study 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 all severity levels of brain injury (from any source) 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). 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 and tissue measures, with the brain injured (and other populations). Finally,
the investigators will assess methods of analysis, combination and 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
are collaborating with Harvard/Boston Children's Hospital in the Angiogenic Signaling
Signatures Identified in Stress and Trauma (ASSIST) sub-study. Oak Ridge National Laboratory
(ORNL) is integrating BIO Study multi-modal data.
As of January 2019, 90 of the planned sample have been recruited and evaluated. Recruitment,
enrollment, evaluation and re-evaluation is continuing.
enrollment, evaluation and re-evaluation is continuing.
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
We found this trial at
1
site
Washington, District of Columbia 20422
Principal Investigator: Julie C Chapman
Phone: 202-745-8000
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