|Study Title, Sponsor, and Principle Investigator||Study Purpose and Detailed Description|
|15 Year Longitudinal Study of TBI Incurred by Members of the Armed Forces in OIF/ OFF
Defense and Veterans Brain Injury Center
PI: COL Michael Lewis, M.D.
|Phase 1: (Surveillance) DVBIC is collaborating with the Defense Manpower Data Center (DMDCJ to assess mortality surveillance of OIF/OEF veterans to determine whether an in-theatrc history of TBI increases risk of death among OIF/OEF veterans. DMDC obtains data from a variety of federal sources including information from the Social Security Administration's Death Master File and deceased benefit information from Veterans' Affairs. To date, DMDC has identified approximately 1.5 million service members who have served in OIF/OEF of which over 15,000 arc no lonecr alive as of March 2011.
Regarding those deaths, DVBIC is in the process of (a) determining cause of death; and (b) history of TBI. A series of statistical analyses will be performed on the data to identify possible trends within the data in an effort to determine factors that may have preventive benefit.
|Phase 2: (Previous TBI Diagnosis) is submitting its protocol as an amendment to the Natural History protocol (Phase 3). Phase 2 is designed to collect ncurobchavioral information on service members and veterans who arc 12 months or more post-TBI diagnosis (dating back to October 2001), as well as trauma controls and healthy controls. Phase 2 includes a second protocol addressing health related quality of life in family caregivers of service members and veterans with TBI. The caregiver protocol will be submitted to OHSP for review last month.|
|Phase 3: (Incident TBI) has received approval for the Natural History protocol from the WRAMC and USUHS IRBs. Recruitment began at WRAMC in May 2011. The study is designed to collect comprehensive pathophysiologic, neurobehavioral, and ncuroimaging information on service members newly diagnosed with TBI, trauma controls, and healthy controls. Annual follow-up brief evaluations will be done and intermittently will include a comprehensive examination similar to baseline.|
|Acute Cognitive and Ncuro behavioral Intervention: Efficacy Evaluation||Study Purpose: To learn more about behavior and everyday functioning after brain injury, and to learn if behavior and functioning gets better with more education about changes after brain injury.|
|Virginia Commonwealth University; U.S. Department of Education
PI: Jeffrey S. Kreutzer, Ph.D.
|Detailed Description: To evaluate the efficacy of the First Steps intervention for improving neurobehavioral functioning, functional status, and life satisfaction, and for increasing knowledge about TBI and compensatory strategics. The First Steps program was developed to address the ncurobc-havioral and emotional concerns of survivors of TBI during the course of inpatient rehabilitation. Program format and content reflects clinical experience and extensive research review. Input from survivors, family members, and rehabilitation staff trained in working with the TBI population has also helped shape the implementation protocol. The foundation of the protocol is a curriculum [Nicmcicr, J., Krcutzer, J., &s Taylor, L.(2005). Acute cognitive and neurobchavioral intervention for individuals with acquired brain injury: Preliminary outcome data. Neuropsychological Rehabilitation, 15(2), 129-146.] The First Steps curriculum consists of 10 lessons and was developed to address the common needs, issues, and concerns of TBI survivors admitted acutely for inpatient rehabilitation.|