View clinical trials related to Traumatic Brain Injury.
Filter by:Will an increase of the dose of mannitol improve the effects on neuromonitoring in patients suffering intracranial hypertension following traumatic brain injury?
Traumatic brain injury (TBI) is among the leading causes of trauma death and disability in both civilian and military populations. The damage that occurs at the instant of trauma cannot be modified; the secondary injuries that occur afterward are the impediments to recovery and can be influenced by the physician. Cerebral ischemia is the most important secondary event that determines outcome following TBI. To minimize ischemic episodes once the patient has arrived at the hospital, most treatments are aimed at optimizing cerebral perfusion pressure (CPP). The cornerstones of these treatments include mannitol, to reduce intracranial pressure (ICP), and catecholamines, such as phenylephrine (PE), to increase mean arterial pressure (MAP), but these agents have undesired side effects. Nevertheless, once they lose potency, there are few alternatives. The main objective of this proposal to develop a new therapeutic option for CPP management in TBI patients using arginine vasopressin (AVP). AVP is the endogenous anti-diuretic hormone. It is FDA-approved for use in the diagnosis and treatment of diabetes insipidus, for the prevention and treatment of post-operative abdominal distention, and in abdominal radiography to dispel interfering gas shadows. It has been used off-label for several other conditions. There is minimal information on its therapeutic potential after TBI. The investigators have demonstrated that AVP during fluid resuscitation rapidly restored hemodynamics, CPP, and improves acute survival in a clinically-relevant model of TBI. The investigators observed similar short term benefits after chest and liver trauma. Nevertheless, AVP has actions that could mask any short term benefit. The investigators have already defined risks and benefits of AVP therapy, relative to PE, in four different clinically-relevant laboratory model. The investigators now plan to evaluate this new therapy relative to the current evidence-based guideline for CPP management in TBI patients. The working hypothesis is that the risk/benefit profile for AVP is equal, or superior to, PE at equi-effective doses for the management of CPP following TBI. A corollary is that a higher CPP can be safely tolerated with AVP vs catecholamines. THE INVESTIGATORS AIM TO: Determine whether AVP is safe and effective to maintain CPP = 60 mm Hg in TBI patients.
Thousands of soldiers, marines, and other military personnel have had injuries to the brain due the wars in Iraq and Afghanistan. In addition, 1.5 million civilians per year in the United States have traumatic brain injuries caused by car accidents, falls, sports-related injuries or assaults. There are important advances in technology that we think will help us learn a lot more about these injuries. One such advance involves new types of MRI scans that we think will be able to show what has happened to the brain after trauma more clearly that regular scans can. These first new scan is called diffusion tensor imaging, which shows injury to the axons (the wiring of the brain). The second new scan is called resting-state functional MRI correlation analysis, which shows how well various parts of the brain are connected to each other. Importantly, the new types of scans can be done using regular scanners that we already have in every major hospital. The innovation is entirely in how the scanners are used and how the resulting pictures are analyzed on a computer after they have been taken. Our overall goal is to see whether these new MRI scans will be useful for people who have had traumatic brain injuries. We have already tested them on some civilian brain injury patients and found them to be very helpful. For this study, we will test them on military personnel who have had traumatic brain injuries caused by explosions. The specific goal will be to see if the amount of injury we see can be used to predict how well the patients will do overall over the next 6-12 months. We think with the new scans we will be able to predict overall outcomes better than with regular scans and other information. A related goal will be to see whether injuries to specific parts of the brain seen by these new scans can be used to predict whether patients will be likely to have specific problems like memory loss, attention deficit, depression, or post-traumatic stress disorder. A final goal will be to repeat the scans 6-12 months later to see whether the new MRI scans can show whether the injuries to the brain have healed, gotten worse, or stayed the same. If the study is successful, it will show that these new MRI techniques can to be used to make earlier and more accurate diagnoses of traumatic brain injury, predictions of the sorts of problems that are likely to occur after brain injury, and assessments of how severe the injuries are. This study will help traumatic brain injury patients. It will be most useful for military personnel who have had brain injuries due to explosions. It is highly likely that it will also be useful for younger adults who have had brain injuries due to other causes like car accidents, sports-related concussions, falls, or assaults. It is possible that but not known for sure whether it will help young children or older adults with traumatic brain injuries. These new scans could help with decisions about whether military personnel can return to duty, what sort of rehabilitation would benefit them most, and what family members should watch for and expect. This could become used in some hospitals within 2 years, and could become standard in every major hospital within 5 years. The new scans could also be helpful in developing new treatments. For example, if a new drug works by blocking injury to the axons, it would be a good idea to test on people who have injury to their axons. Right now we have no good way to tell who these people are, and so a new drug like this would get tested on lots of people who don't have injured axons, along with those who do. This would make it harder to tell if the new drug is working. With the new scans we should be able to tell who has injured axons, tell how severe the injury is, and figure out whom to test the drugs on. It will likely take 10 years or more to develop new drugs like this. Further in the future, the new scans could be used to help guide surgery to implant computer chips to help rewire the brain. We don't know how long this will take, but estimate 15-20 years or more. Overall MRI scanning is very safe and has no known major risks. Because the scanner uses strong magnets, anyone with metal objects in their bodies can't be scanned, as this could be dangerous. We will make sure that no one with metal objects in their bodies is included in the study. There can be some psychological risks involved in taking tests and answering questions, but these are usually mild and can be managed. There is always a risk that important confidential information will be made public and that this could have consequences. We will do everything possible to maintain confidentiality. Nearly all of the information will only be identified using a code number and not by the name of the person, and all of it will be kept securely.
Trauma patients are at risk for serious head trauma. The consequences of serious head trauma are often life altering. Currently, the only method available to rapidly assess the severity of head injury and need for neurosurgical intervention is the CT scan. This time consuming test requires transportation of a potentially unstable patient to the CT scanner. The investigators goal in traumatic brain injury is to identify early those patients who may require neurosurgical intervention. Brain swelling (elevated intracranial pressure) is transmitted to the eye and this can be measured with ultrasound. The investigators hypothesis is that this test will rule out significant elevations in intracranial pressure and perform as well as CT scan in doing this. The investigators study aims to demonstrate that ultrasound of the optic nerve is as good as CT scan in ruling out clinically significant elevations in pressure within the brain. After consent has been obtained, any trauma patient who has an indication to undergo CT scan of the brain will also undergo ultrasound of the eye. A radiologist will then review the CT scans to determine if signs of elevated intracranial pressure are present. The investigators hope to demonstrate that a bedside ultrasound performed in the trauma suite is reliable for ruling out the possibility of elevated intracranial pressure. **Update August 2009** Currently, deferred consent has been obtained from our REB allowing us to defer consent for this intervention of minimal risk. As well, REB has also approved phone consent in the interim.
This study is being conducted to compare healthy patients versus patients with muscle tightness in their leg(s) after an acquired brain injury using walking trials time, a balance test, and foot pressure data. This data is obtained using foot pressure sensors, timers, and distance walked.
This study will test if patients with moderate to severe traumatic brain injuries also have endocrine abnormalities, examine any existing relationships among fatigue, depression and endocrine abnormalities, and the relationship between endocrine abnormalities, quality of life, and community integration.
Traumatic brain injury (TBI) has been called the signature injury of the Iraq War. This pilot study investigated family needs of 6 rural families caring for a Veteran with TBI. Two Veterans had moderate TBI and all had comorbid post traumatic stress disorder diagnoses. The veterans were 1 to 5 years post-injury. Families were reluctant to include others in helping the family because of privacy concerns, desire for independence, and negative employment repercussions if the extent of the TBI deficit became known in the community. Most were still employed, despite TBI deficits. Despite having previously received information, families still had substantial needs for information about the condition and its prognosis and sequelae (e.g., why things happen, unsafe/frightening behaviors, work, finances, communication changes) and the availability and types of services (e.g., who to contact, benefits, help needed)
Growth Hormone (GH) deficiency, defined by insufficient GH response to a variety of stimulating compounds, is found in 20-35% of adults who suffer traumatic brain injuries (TBI) requiring inpatient rehabilitation1. However, there is no accepted gold standard for diagnosing GH deficiency in this population. Further, the major effector molecule of the somatotropic axis, Insulin-Like Growth Factor-1 (IGF-1) has recently been recognized as an important neurotrophic agent. Since most repair and regeneration after TBI occurs within the first few months after injury, absolute or relative deficiencies of GH and IGF-1 in the subacute period after TBI are potentially important factors why some patients fail to make a good functional recovery. The proposed study is a randomized, double-blind, placebo-controlled trial of rhGH, starting at 1 month post TBI, continuing for 6 months. This study has one primary hypothesis, that treatment with recombinant human Growth Hormone (rhGH) in the subacute period after TBI results in improved functional outcome 6 months after injury. As secondary hypotheses, we will investigate what is the optimal method to diagnose GH deficiency in TBI survivors and study the relationship between GH deficiency and insufficiency and functional recovery.
This project seeks to determine the effect of prehospital resuscitation with hypertonic saline vs. conventional crystalloids on the inflammatory response after injury. The leading cause of late mortality following injury is multiple organ dysfunction syndrome (MODS), which results from a dysfunctional inflammatory response after injury. Previous studies suggest that hypertonic saline may be beneficial by modulating this initial response and decreasing subsequent organ injury. This project takes advantage of a unique opportunity, afforded by an NIH-funded multi-center clinical trial of hypertonic resuscitation (conducted by the Resuscitation Outcomes Consortium), to obtain blood samples from patients enrolled in this trial to analyze inflammatory responses early after hypertonic vs. conventional resuscitation. This study was an ancillary study to the main randomized clinical trial and thus prospective observational in nature The proposed study will be carried out in experiments grouped in three Specific Aims: Aim 1 provides a thorough investigation of the immunomodulatory response following hypertonic resuscitation with regard to neutrophil, monocyte, and T cell responses at serial time points after injury and resuscitation. Aim 2 comprises experiments to investigate the mechanisms by which hypertonicity may alter inflammatory cell signaling. Aim 3 seeks to correlate the laboratory findings with clinical endpoints reflective of immune dysfunction including inflammation, organ failure, nosocomial infection, and sepsis. The investigators hypothesize that hypertonic resuscitation will be associated with modulation of the excessive inflammatory response seen after injury and thus will result in reduced rates of inflammatory organ injury.
The purpose of this study is to determine whether mindfulness-based cognitive therapy is effective in reducing depression symptoms in individuals who have experienced a traumatic brain injury. The investigators hypothesize that participants who are given the ten-week intervention will have fewer depression symptoms than the participants in the control group, and this improvement will be maintained at the three-month follow-up assessment.