Active clinical trials for "Brain Injuries, Traumatic"

Background: To study intensive targeted cognitive rehabilitation of attention in the acute (<4 months) and subacute rehabilitation phases (4 -12 months) after acquired brain injury and to evaluate the effects on function, activity and participation (return to work). Design: prospective, randomised, controlled study. Methods: 120 consecutive patients with stroke or traumatic brain injury are randomised to 20 hours of intensive attention training by Attention Process Training or by standard, activity based training. Progress is evaluated by Statistical Process Control and by pre and post measurement of functional and activity levels. Return to work is also evaluated in the post-acute phase. Primary endpoints are the changes in the attention measure, Paced Auditory Serial Addition Test and changes in work ability. Secondary endpoints include measurement of cognitive functions, activity and work return. There are 3, 6 and 12-month follow ups focussing on health economics. Discussion: The study will provide information on rehabilitation of attention in the early phases after acquired brain injury (ABI); effects on function, activity and return to work. Further, the application of Statistical Process Control might enable closer investigation of the cognitive changes after acquired brain injury and demonstrate the usefulness of process measures in rehabilitation.

Mayo Clinic has been funded by the National Institute on Disability Independent Living & Rehabilitation Research (NIDILRR) as a Traumatic Brain Injury (TBI) Model System Center continuously since 1998. We have successfully competed for this funding because we consistently produce high quality research and because we provide comprehensive team-based rehabilitation services to people with TBI and their families over the continuum of care that is associated with superior outcomes. Lack of access to specialized TBI care is the most common need identified by individuals after they are hospitalized for TBI. The upper Midwest has some of the highest populations of rural dwellers, the elderly, and Native Americans, all of whom have a high risk for TBI and are more likely to have limited access to rehabilitation services after acute care. Explosive advances in communication technology have brought tele-medicine to the forefront of health care. The CONNECT trial will test the effectiveness of using modern technologies - such as phone consultation and other telehealth communication systems - to deliver specialized brain rehabilitation resources remotely to patients and providers in the upper Midwest. The groups targeted by the CONNECT trial are: Individuals recently hospitalized with TBI; Their families; Their local health care and other providers (primary care providers, psychologists, therapists, social service providers, job counselors). The CONNECT trial is the first study of this scope - in 4 upper Midwest states (MN, IA, ND, and SD), 3 health systems (Mayo Clinic, Altru Health System in ND, Regional Health in SD), and 2 state Departments of Health (IA, MN) - using electronic technology to see if outcome can be improved by providing care with no face-to-face contact. The trial will study whether outcomes over three years are different in the group receiving this remotely provided model of care compared to a matched group that receives usual care in their communities. The desired long term outcome of this study is to increase our capacity to provide care and to reduce barriers to accessing specialized TBI rehabilitation services faced by individuals with TBI and their families.

This study is investigating one way to improve health and healthy habits after traumatic brain injury (TBI). The primary goal of this study is to determine if a brief intervention accommodated for persons with moderate or severe TBI is effective in reducing alcohol misuse during the year following injury. It is hypothesized that an adapted Screening, Education and Brief Intervention (adapted SBI) will reduce the number of alcoholic drinks consumed per week over the year following discharge from inpatient rehabilitation, in comparison to a Screening and Education Attention Control condition (SEA control).

Severe traumatic brain injury is associated with life-threatening and incapacitating secondary injury. Contemporary therapeutic interventions are aimed at preventing and treating secondary damage. In this context, improved cerebral metabolism is an important target in modern neurointensive care. The main hypothesis is that continuous intravenous infusion of glutamyl-alanyl dipeptide restores disturbed brain metabolism following severe traumatic brain injury.

This study compares the effects of Individualized Scheduled Telephone Support (ISTS) and Usual Care (UC) for service members with Mild Traumatic Brain Injury (mTBI). A total of 400 service members will participate in this study. ISTS is a telephone intervention that provides injury-related education, training in problem solving, and focused behavioral strategies for problems (e.g. anxiety, depression) that commonly co-occur with MTBI. ISTS also includes access to usual care and web-based and printed educational material. The 12 phone calls included in ISTS will be administered over a 6-month period. UC is the usual care provided to service members attending the Traumatic Brain Injury (TBI) Clinics at Madigan Army Medical Center and Womack Army Medical Center, plus web-based education and 12 mailings of educational materials over a 6-month period. Subjects will complete major assessments at study entry and then 6 months and 12 months later. The primary aim of the study is to compare the effects of ISTS and UC on post-concussive symptoms and emotional distress at the 6-month assessment. The investigators predict that participants who receive ISTS will report lower levels of post-concussive symptoms and emotional distress at the 6-month assessment. Secondary aims include comparing the longer term effects of ISTS and UC at the 12-month assessment, as well as comparing their effects on other outcomes such as post-traumatic stress symptoms, quality of life, resilience, and work activity.

The aim of this study is to determine whether passive gait training increases arousal, demonstrated as changes in EEG (electroencephalogram) activity. Hypotheses: 1) Passive gait training increases EEG-frequency in patients with impaired consciousness due to severe traumatic brain injury. 2) Passive gait training increases conductivity speed of the cognitive P300-component of ERP in patients with impaired consciousness due to severe traumatic brain injury.

The purpose of this study is to determine whether rosuvastatin could alter the immunological response after head injury by modulating TNF-alpha,IL6,IL-1.

The purpose of this study is to determine if hyperbaric oxygen therapy (HBOT) improves the cognitive function of OIF/OEF individuals who have chronic mild to moderate traumatic brain injury (TBI). Cognitive function includes such things as thinking, remembering, recognition, concentration ability and perception. Traumatic brain injury is common with head injuries caused by blows to the head, nearby explosions, or concussion. Subjects will be assigned to an intervention or sham arm. Computer based cognitive tests will be used as outcome measures. Subjects are enrolled by invitation only.

Neurocritical ill patients are frequently transfused. Red blood cell transfusion (RBCT) in these patients has been associated with deleterious effects, including higher rates of nosocomial infections, multi-organ failure, and mortality. Therefore, it seems crucial to avoid any unnecessary RBCT. Most critically ill patients tolerate hemoglobin levels near 7 g/dL without an increase in morbidity or mortality rates. In this regard, a recent sub-analysis of TRICC trial has showed that TBI patients may tolerate hemoglobin levels as low as 7 g/dL, but other studies including neurocritical patients suggested that severe anemia may worsen clinical outcome. Therefore, optimal hemoglobin levels in neurocritical care patients remain largely unknown. Some textbooks and guidelines recommend to transfuse these patients to reach hemoglobin levels near to 10 g/dL, despite the lack of a solid scientific background supporting this target. Even though it has not been demonstrated, hemoglobin-based RBCT prescription could result in over- or under-transfusion in neurocritical patients. Alternatively, it has been suggested that more physiological transfusion triggers, using direct signals coming from the brain, will progressively replace arbitrary hemoglobin-based transfusion triggers in the neurocritical patients [65]. At the neurocritical units, patients are often monitored by using non-invasive methods, such as near infrared spectroscopy which indirectly measures regional cerebral oxygen saturation (rSO2). Changes in rSO2 values have been shown to directly correlate with changes in erythrocyte mass, thus increasing with RBCT and decreasing with blood losses. Moreover, rSO2 values also show a good correlation with clinical outcome and other variables which are often monitored in TBI patients. The purpose of this study is to ascertain as to whether rSO2 levels are more efficacious than conventional hemoglobin levels in guiding RBCT in patients admitted to a neurocritical care unit.

The purpose of the study is to determine the efficacy of aerobic exercise for improving cognition, mood, and fatigue after Traumatic Brain Injury (TBI) as well as examine the role of Brain Derived Neurotropic Factor (BDNF) and peripheral Vascular Endothelial Growth Factor (VEGF) as mediators of response to exercise.