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Brain Injury Outcomes (BIO) Study (BIO)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00724607
First Posted: July 29, 2008
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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 ]
    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
Actual Study Start Date: May 6, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724607


Locations
United States, District of Columbia
Washington DC VA Medical Center, Washington, DC
Washington, District of Columbia, United States, 20422
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 ( Other Identifier: IRB )
First Submitted: July 23, 2008
First Posted: July 29, 2008
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Brain Concussion
Trauma and Stressor Related Disorders
Mental Disorders
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating