Studies Currently in Progress

The Defense and Veterans Brain Injury Center (DVBIC) is continually proposing, submitting, conducting and completing many studies related to traumatic brain injury (TBI).  Those included on the partial list that follows are active studies that have received approval from both a local and a second level institutional review board (IRB):

2009

Start Date, 12/1/2009:	Defense and Veterans Brain Injury Center (DVBIC) Prospective Traumatic Brain Injury Tracking Protocol
Status:	Open
Description:	This is a descriptive observational study comparing symptoms and problems associated with traumatic brain injury (TBI) for former military and Department of Veteran Affairs patients known to have had TBI and registered in the DVBIC Head Injury Registry and uninjured friend/relative controls nominated by consenting subjects. A follow up questionnaire based upon the Centers for Disease Control and Prevention (CDC) prevalence study in South Carolina will be used for the documentation of TBI sequelae. The use of a set of common questions will permit an eventual comparison of findings from the two studies.
Cohort:	500 military health care beneficiaries, ages 18 and over who present to the Minneapolis VAMC with a TBI.
DVBIC Site(s):	Veterans Affairs Medical Center (VAMC) Minneapolis, MN

Start Date, 12/1/2009:	The Effectiveness of Methylphenidate Therapy During Early TBI Recovery
Status:	Open and Accuring
Description:	To provide Class I evidence on the effectiveness of methylphenidate initiated during acute rehabilitation in improving outcome after severe traumatic brain injury (TBI).
Cohort:	Patients who present with non-penetrating TBI of severe severity - with loss of consciousness/post traumatic stress seven days or longer. Six months or less since previous injury.
DVBIC Site(s):	Veterans Affairs Medical Center (VAMC) Minneapolis, MN

 

Start Date, 9/2009:	The Effectiveness of Methylphenidate Therapy During Early TBI Recovery
Status:	Open and Accuring
Description:	To provide Class I evidence on the effectiveness of methylphenidate initiated during acute rehabilitation in improving outcome after severe traumatic brain injury (TBI).
Cohort:	Patients who present with non-penetrating TBI of severe severity - with loss of consciousness/post traumatic stress seven days or longer. Six months or less since injury with no previous rehab stay > than six days for current injury.
DVBIC Site(s):	Veterans Affairs Palo Alto Health Care System (VAPAHCS) Palo Alto, CA

Start Date, 9/30/2009:	Post-Traumatic Headache in Soldiers: A retrospective record review of patients presenting to the TBI Center for evaluation and treatment of Headache
Status:	Open for data analysis only
Description:	Retrospective study of traumatic brain injury (TBI) clinic patients. To describe in detail the characteristics of post-traumatic headache in patients presenting for TBI evaluation. The second goal is to classify headache based upon existing criteria adding to the existing literature on post-traumatic headache.
Cohort:	TBI clinic patients seen at Fort Bragg evaluated for post-traumatic headache
DVBIC Site(s):	Fort Bragg, NC

 
2008
 

Start Date, 3/2008:	Long-Term Outcomes after TBI
Status:	Open and Accruing
Description:	Comprehensive phone interview of patients and their informants, 5+ years after moderate to severe traumatic brain innjury (TBI). Subjects: 293 participants in DVBIC's Veterans Affairs Rehab study (phases 1 & 2, 1993 to 2005) at Palo Alto VA. Goals: analysis of outcomes and their predictors in patients and caretakers, provide psycho education & referrals, pilot methods for the DVBIC 15-year Outcome Study.
Cohort:	Subjects in VA Rehab Trial phase I & II (Palo Alto DVBIC data)
DVBIC Site(s):	Veterans Affairs Palo Alto Health Care System (VAPAHCS) Palo Alto, CA

 
2007
 

Start Date, 6/2007:	TBI/Polytrauma Family Needs Assessment
Status:	Open and Accruing
Description:	The purpose of this study is to identify military family needs following a traumatic brain injury/polytrauma or for the preliminary development of a family intervention based on identified educational and psychosocial needs. This study uses a simple, two-session, mixed method design.
Cohort:	Family members of service personnel who have had a TBI.
DVBIC Site(s):	Hunter Holmes McGuire Veteran Affairs Medical Center Richmond, VA

Start Date, 2007:	Defense and Veterans Brain Injury Center (DVBIC) Prospective Traumatic Brain Injury Tracking Protocol
Status:	Open and Accruing
Description:	This is a descriptive observational study comparing symptoms and problems associated with traumatic brain injury (TBI) for former military and Department of Veteran Affairs patients known to have had TBI and registered in the DVBIC Head Injury Registry and uninjured friend/relative controls nominated by consenting subjects. A follow-up questionnaire based upon the Centers for Disease Control and Prevention (CDC) prevalence study in South Carolina will be used for the documentation of TBI sequelae. The use of a set of common questions will permit an eventual comparison of findings from the two studies.
Cohort:	Military health care beneficiaries, ages 18 and over, who present with a traumatic brain injury.
DVBIC Site(s):	Hunter Holmes McGuire Veteran Affairs Medical Center Richmond, VA

 

Start Date, 2007:	VA Polytrauma Rehabilitation Center (PRC) Traumatic Brain Injury Model Systems (TBIMS)
Status:	Open and Accruing
Description:	The purpose of this study is to identify military family needs following a traumatic brain injury/polytrauma or for the preliminary development of a family intervention based on identified educational and psychosocial needs. This study uses a simple, two-session, mixed method design.
Cohort:	Active duty or veterans with TBI
DVBIC Site(s):	Hunter Holmes McGuire Veteran Affairs Medical Center Richmond, VA

2006

Start Date, 8/2006:	Assessing pain in persons with polytrauma and differing cognitive levels: intensity scale utility and reliability.
Status:	Open and Accruing
Description:	The purpose of this study is to assess the utility and reliability of four pain assessment instruments during the rehabilitation of persons with polytrauma and to examine the influence of cognitive impairment. The ultimate goal of this study is to improve outcomes by providing evidence-based clinical care recommendations for pain intensity scale use in polytrauma patients undergoing rehabilitation. The research design will be a pilot prospective study with repeated measures using randomly assigned alternate methods.
Cohort:	Inpatient polytrauma rehab patients with pain.
DVBIC Site(s):	Hunter Holmes McGuire Veteran Affairs Medical Center Richmond, VA

2005

Start Date, 3/2005:	Defense and Veterans Brain Injury Center (DVBIC) Prospective Traumatic Brain Injury Tracking Protocol
Status:	Open and Accruing
Description:	A multi center, descriptive study which involves a description of the history and clinical exam in patients with various types of traumatic brain injury (TBI); to correlate TBI etiology with severity levels, demographics, associated injuries, symptomatology and outcomes.
Cohort:	Mild to moderate TBI patients within five years of injury.
DVBIC Site(s):	Veterans Affairs Palo Alto Health Care System (VAPAHCS) Palo Alto, CA

Start Date, 3/22/2005:	Defense and Veterans Brain Injury Center (DVBIC) Prospective Traumatic Brain Injury Tracking Protocol
Status:	Open for enrollment
Description:	The overall objective of this proposal is to ensure that all military and Department of Veteran Affairs patients with traumatic brain injury (TBI) receive TBI-specific screening, treatment and follow-up, while at the same time collecting standardized patient outcome data.
Cohort:	Active duty service members from all branches.
DVBIC Site(s):	Wilford Hall Medical Center San Antonio, TX

Start Date, 2005:	The Effectiveness of Methylphenidate Therapy During Early TBI Recovery
Status:	Open and Accruing
Description:	To provide Class I evidence on the effectiveness of methylphenidate initiated during acute rehabilitation in improving outcome after severe traumatic brain injury (TBI).
Cohort:	Patients who present with a non-penetrating TBI of severe severity - with loss of consciousness/post traumatic stress seven days or longer. Six months or less since injury with no previous rehab stay > than 6 days for current injury.
DVBIC Site(s):	James A Haley Veterans' Hospital Tampa, FL

Start Date, 2005:	The Effectiveness of Methylphenidate Therapy During Early TBI Recovery
Status:	Open and Accruing
Description:	To provide Class I evidence on the effectiveness of methylphenidate initiated during acute rehabilitation in improving outcome after severe traumatic brain injury (TBI).
Cohort:	Patients who present with a non-penetrating TBI of severe severity - with loss of consciousness/post traumatic stress seven days or longer. Six months or less since injury with no previous rehab stay > than 6 days for current injury.
DVBIC Site(s):	Hunter Holmes McGuire Veteran Affairs Medical Center Richmond, VA

1998

Start Date, 7/13/1998:	Combat Training TBI: A Surveillance Study in Paratroopers
Status:	Open
Description:	To determine the incidence and performance impact of traumatic brain injuries (TBI) among Army paratroopers and identify possible prevention measures and therapeutic interventions.
Cohort:	Active duty service members; baseline group (no TBI or > 90 days; Post-injury group (TBI < 90 days).
DVBIC Site(s):	Fort Bragg, NC

1995

Start Date, 5/01/1995:	CORE Phase 2
Status:	Open for data analysis only
Description:	To determine the type of problems that patients who have sustained a traumatic brain injury (TBI) experience and to monitor their recovery over time. Specific objectives are to evaluate the effectiveness and relative cost efficiency of two alternative TBI rehabilitation strategies: Cognitive Rehabilitation Focus versus Functional Rehabilitation Focus and to further the development and validate outcome measures which define the short and long-term neurologic, cognitive, behavioral and psychosocial consequences of moderate to severe TBI.
Cohort:	Mild to moderate TBI patients seen at Tampa.
DVBIC Site(s):	James A Haley Veterans' Hospital Tampa, FL

1993

Start Date, 7/13/1993:	CORE Phase 1
Status:	Open for data analysis only
Description:	The purpose of this study is to evaluate the type of problems experienced by individuals who sustain a traumatic brain injury (TBI) and to monitor their recovery.
Cohort:	Mild to moderate TBI patients seen at Tampa.
DVBIC Site(s):	James A Haley Veterans' Hospital Tampa, FL

Start Date, 5/06/1993:	Traumatic Brain Injury Rehabilitation: A Controlled, Randomized MultiCenter Study of Two Interdisciplinary Programs with Adjuvant Pharmacology (CORE)
Status:	Open
Description:	All eligible patients will be randomized to one of four treatment groups. A factorial experimental design will be utilized in order to treat simultaneously for the effects of rehabilitation approach and drug upon outcome in TBI patients. This design will permit us to evaluate the separate effects of treatment approach, drug, and their interactions.
Cohort:	Military health care beneficiaries, ages 18 and over who present to the MNVAMC with a traumatic brain injury.
DVBIC Site(s):	Veterans Affairs Medical Center (VAMC) Minneapolis, MN