Brain Injury Outcomes (BIO) Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Department of Veterans Affairs
Sponsor:
Collaborators:
Children's Hospital Boston
Oak Ridge National Laboratory
Johns Hopkins University
Georgetown University School of Medicine
NED Biosystems
ASSIST Medical Research Foundation (AMRF)
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00724607
First received: July 23, 2008
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

Active duty military personnel serving in the current and recent conflicts in Afghanistan and Iraq are frequently exposed to blasts.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 mTBI with and without persisting symptoms and various co-morbidities including posttraumatic stress disorder (PTSD). Fourth, we intend to advance diffusion imaging, as well as other types of imaging, for clinical use 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.


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 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)
Groups/Cohorts
Group 1
Validation study of screening instrument.

Detailed Description:

As of November 2013, 89 of the planned sample have been recruited and evaluated. Recruitment and enrollment is continuing.

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT00724607

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

Locations
United States, District of Columbia
VA Medical Center, 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
Children's Hospital Boston
Oak Ridge National Laboratory
Johns Hopkins University
Georgetown University School of Medicine
NED Biosystems
ASSIST Medical Research Foundation (AMRF)
Investigators
Principal Investigator: Julie C Chapman VA Medical Center, DC
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00724607     History of Changes
Other Study ID Numbers: SHP 08-167, 01133
Study First Received: July 23, 2008
Last Updated: June 2, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Concussion, traumatic brain injury
Screening instrument
Diffusion Tensor Imaging
Posttraumatic stress disorder

Additional relevant MeSH terms:
Brain Concussion
Stress Disorders, Post-Traumatic
Stress Disorders, 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
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 10, 2014