Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 59 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
TBI (Case) Group Members of the TBI group have sustained a TBI in accordance with inclusion/exclusion criteria. However, the investigative staff administering, scoring, analyzing and interpreting the data will be blinded to the group status of the participant.
Non-TBI (Control) Group Members of the Non-TBI group have not sustained a TBI and are in accordance with other provisions of the inclusion/exclusion criteria. However, the investigative staff administering, scoring, analyzing and interpreting the data will be blinded to the group status of the participant. This longitudinal study will utilize a control group to account for normal aging and other control factors.
Non-TBI Non-deployed (Control) Group Members of the Non-TBI Non-Deployed group have neither sustained a TBI nor have been deployed but are in accordance with other provisions of the inclusion/exclusion criteria. However, the investigative staff administering, scoring, analyzing and interpreting the data will be blinded to the group status of the participant. This longitudinal study will utilize this Non-deployed control group to account for deployment-specific factors.

Recruiting Locations

Washington DC VA Medical Center, Washington, DC
Washington, District of Columbia 20422
Contact:
Julie C Chapman
202-745-8000
julie.chapman@va.gov

More Details

Status
Recruiting
Sponsor
VA Office of Research and Development

Study Contact

Julie C Chapman
(202) 745-8000
julie.chapman@va.gov

Detailed Description

As of January 2019, 90 of the planned sample have been recruited and evaluated. Recruitment, enrollment, evaluation and re-evaluation is continuing.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.