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Brain Injury Outcomes (BIO) Study (BIO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by VA Office of Research and Development
Sponsor:
Collaborators:
Boston Children’s Hospital
Oak Ridge National Laboratory
Johns Hopkins University
ASSIST Medical Research Foundation
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00724607
First received: July 23, 2008
Last updated: July 21, 2016
Last verified: July 2016
  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.


Condition
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 VA Office of Research and Development:

Primary Outcome Measures:
  • Fractional anisotropy (FA) [ Time Frame: Every two years ] [ Designated as safety issue: No ]
    In this longitudinal study with multiple measurement modalities (i.e., neuroimaging, biospecimens, 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.


Biospecimen Retention:   Samples With DNA
Tissue samples are requested for 1.) current laboratory measures, 2.) current genomic, immunologic, angiogenic 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)
Groups/Cohorts
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.

Detailed Description:
As of February 2016, 91 of the planned sample have been recruited and evaluated. Recruitment, enrollment, evaluation and re-evaluation is continuing.
  Eligibility

Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
OEF/OIF/OND Veterans with and without mTBI and/or PTSD
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
  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 ClinicalTrials.gov identifier: NCT00724607

Contacts
Contact: Julie C Chapman (202) 745-8000 ext 6207 julie.chapman@va.gov

Locations
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    julie.chapman@va.gov   
Principal Investigator: Julie C Chapman         
Sponsors and Collaborators
VA Office of Research and Development
Boston Children’s Hospital
Oak Ridge National Laboratory
Johns Hopkins University
ASSIST Medical Research Foundation
Investigators
Principal Investigator: Julie C Chapman Washington DC VA Medical Center, Washington, DC
  More Information

Additional Information:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00724607     History of Changes
Other Study ID Numbers: SHP 08-167  01133 
Study First Received: July 23, 2008
Last Updated: July 21, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by VA Office of Research and Development:
Concussion, traumatic brain injury
Screening
neuroimaging
Posttraumatic stress disorder

Additional relevant MeSH terms:
Brain Injuries
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Trauma and Stressor Related Disorders
Mental Disorders
Head Injuries, Closed
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on September 26, 2016