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Brain Injuries clinical trials

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NCT ID: NCT00783809 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure

MOONSTRIP
Start date: October 2008
Phase: N/A
Study type: Observational

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.

NCT ID: NCT00779324 Completed - Brain Injury Clinical Trials

Amantadine for the Treatment of Traumatic Brain Injury Irritability and Aggression: A Multi-site Study

Start date: August 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to study the effect of amantadine on irritability and aggression caused by traumatic brain injury.

NCT ID: NCT00775775 Recruiting - Clinical trials for Traumatic Brain Injury

Fatigue, Sleep Disorders and Endocrine Abnormalities in TBI Patients

Start date: May 2003
Phase: N/A
Study type: Observational

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.

NCT ID: NCT00771277 Completed - Clinical trials for Traumatic Brain Injury

Team Based Initiative Support

Start date: September 2008
Phase: N/A
Study type: Interventional

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)

NCT ID: NCT00766038 Completed - Clinical trials for Traumatic Brain Injury

Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.

Growth-TBI
Start date: September 2008
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT00761228 Suspended - Brain Injury Clinical Trials

Efficacy Study of NH001 in Vegetative State & Minimally Conscious State Following a Traumatic Brain Injury

NH001-2
Start date: July 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the drug apomorphine in subjects who are in a Vegetative State or a Minimally Conscious State.

NCT ID: NCT00760903 Withdrawn - Brain Trauma Clinical Trials

Magnetic Resonance (MR) Spectroscopy and Diffusion Tensor Imaging in Determining Brain Injury and Subsequent Clinical Outcome in Patients of Moderate Brain Trauma

Start date: June 2003
Phase: N/A
Study type: Observational

The purpose of this study is to use magnetic resonance spectroscopy (MRS) and diffusion tensor imaging (DTI) to assess for traumatic brain injury and determine if there is any correlation of these findings to clinical outcome. MR spectroscopy using 2D-CSI (a multi voxel technique) of the corpus callosum, basal ganglia, lobar white matter and brainstem may reveal areas of injury and quantification of the metabolites from these areas may be used to correlate with imaging findings and clinical evaluation. White matter disruption in these areas is commonly seen after TBI, caused by diffuse axonal injury. It has been implicated in the long term outcomes in these patients, but has been difficult to assess by standard radiologic studies. By the use of DTI it may be possible to demonstrate damaged white matter tracts which could be helpful in the evaluation of traumatic brain injury. Most TBI subjects have injuries that involved torque to the brain. This results in a shearing injury to the long white matter tracts, which has been hypothesized to be related to cognitive outcome. Also, to demonstrate that MRS and DTI prove valuable in predicting outcome in patients of moderate brain trauma by conducting progressive studies acutely (within 24 hours) and long term (4-6 weeks). Most patients will most likely be followed clinically for over a year, and, if clinical indicated, farther scanning can be done at a later date. By comparing fraction anisotropy, ADC values, and metabolic ratios by the use of DTI and MRS in the adult and pediatric populations, may help to assess differences in recovery. Lastly, a comparison between the two groups in changes in brain metabolism and/or white matter tract disruption/re-connection after TBI with and/or without links to outcome can be done.

NCT ID: NCT00760734 Completed - Clinical trials for Post Traumatic Stress Disorder

Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)

Start date: September 2008
Phase: Phase 1
Study type: Interventional

This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.

NCT ID: NCT00755209 Completed - Brain Injuries Clinical Trials

Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Traumatic Brain Injury

Start date: October 2008
Phase: Phase 3
Study type: Interventional

The study's objective is to evaluate the effectiveness and safety of tranexamic acid for adult patients with moderate to severe TBI.With the research question as "Does TXA reduce the incidence of progressive intracranial haemorrhage by 50% compared to placebo in moderate to severe adult TBI patients at Khon Kaen Hospital?"

NCT ID: NCT00750997 Terminated - Clinical trials for Traumatic Brain Injury

Hypertonic Modulation of Inflammation Following Injury

Start date: November 2007
Phase: N/A
Study type: Observational

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.