Brain Injury Outcomes (BIO) Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Department of Veterans Affairs
Children's Hospital Boston
Oak Ridge National Laboratory
Johns Hopkins University
NED Biosystems
ASSIST Medical Research Foundation (AMRF)
Information provided by (Responsible Party):
Department of Veterans Affairs Identifier:
First received: July 23, 2008
Last updated: April 21, 2015
Last verified: April 2015

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 from 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 our participants for signs of emerging systems or associated vulnerabilities. Identification of abnormality profiles for all severity levels of brain injury (from any source) reflects a second long-range goal. Third, we will examine and compare physiology between veterans who have sustained a 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, we intend to facilitate the clinical use of advanced methodologies, such as brain imaging and tissue measures, with the brain injured (and other populations). Finally, we 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. We 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.

Brain Concussion
Posttraumatic Stress Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Validation of Brief Objective Neurobehavioral Detectors of Mild TBI

Resource links provided by NLM:

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Modality: Neuroimaging; Primary Outcome Measures: FA, MD, AD, RD [ Time Frame: Every two years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tissue samples are requested for 1.) current laboratory measures, 2.) current genomic, immunologic and endocrine measures, and 3.) future unknown measures.

Estimated Enrollment: 300
Study Start Date: May 2008
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Group 1
Validation study of screening instrument.

Detailed Description:

As of October 2014, 91 of the planned sample have been recruited and evaluated. Recruitment, enrollment, evaluation and re-evaluation is continuing.


Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

OEF/OIF veterans with and without mTBI and/or PTSD


Inclusion Criteria:

Inclusion criteria for TBI Group (Case Group):

TBI group veterans must:

  • be enrolled at the Washington, DC VAMC
  • be an OEF/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 mild brain injury (based upon VHA criteria)
  • have a brain injury related to blast exposure
  • 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
  • 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., CNS 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00724607

Contact: Julie C Chapman (202) 745-8000 ext 6207

United States, District of Columbia
Washington DC VA Medical Center, Washington, DC Recruiting
Washington, District of Columbia, United States, 20422
Contact: Julie C Chapman    202-745-8000 ext 6207   
Principal Investigator: Julie C Chapman         
Sponsors and Collaborators
Children's Hospital Boston
Oak Ridge National Laboratory
Johns Hopkins University
NED Biosystems
ASSIST Medical Research Foundation (AMRF)
Principal Investigator: Julie C Chapman Washington DC VA Medical Center, Washington, DC
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs Identifier: NCT00724607     History of Changes
Other Study ID Numbers: SHP 08-167, 01133
Study First Received: July 23, 2008
Last Updated: April 21, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Concussion, traumatic brain injury
Posttraumatic stress disorder

Additional relevant MeSH terms:
Brain Concussion
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Brain Diseases
Brain Injuries
Central Nervous System Diseases
Craniocerebral Trauma
Head Injuries, Closed
Mental Disorders
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Wounds, Nonpenetrating processed this record on August 26, 2015