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Brain Injuries clinical trials

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NCT ID: NCT01801969 Active, not recruiting - Quality of Life Clinical Trials

Return to Work and QOL Following TBI. Impact of Rehabilitation Service.

Start date: February 2013
Phase: N/A
Study type: Observational

The proportion of patients who return to work after surviving severe traumatic brain injury (TBI) has been estimated in number of studies but results do not agree.This may be due to complex interaction between many factors, including available rehabilitation services. In Denmark rehabilitation services vary been regions and municipalities. Hospital based rehabilitation is organized by the regions. Rehabilitation outside the hospitals is organized by the municipalities The first purpose of this study is to investigate a possible link between centralized hospital based rehabilitation and better return to work / quality of life. The second purpose is to investigate whether municipality size affects quality of life and return to work after severe TBI. Data on return to work are derived from a national register on labor market attachment. Data on quality of life are derived from a questionnaire. The study population is identified from the Danish Head Trauma Database. The completeness and accuracy of the database will be investigated as the first part of the project.

NCT ID: NCT01690819 Active, not recruiting - Clinical trials for Injuries, Acute Brain

Protective Ventilatory Strategy in Severe Acute Brain Injury

PROLABI
Start date: October 2013
Phase: N/A
Study type: Interventional

Acute respiratory distress syndrome (ARDS) occurs in almost 20% of patients with severe acute brain injury and is associated with increased morbidity and mortality. A massive increase in sympathetic activity and an increased production of proinflammatory cytokines released into the systemic circulation are the most important recognized mechanisms. Altered blood brain barrier after injury causes spillover of inflammatory mediators from the brain into the systemic circulation leading to peripheral organs damage. The adrenergic surge induces an increase in vascular hydrostatic pressure and lung capillary permeability, causing an alteration of alveolar capillary barrier with fluid accumulation, resulting in ARDS. The main goal of mechanical ventilation after acute brain injury are the maintenance of optimal oxygenation, and a tight control of carbon dioxide tension, although ventilatory settings to be used to obtain these targets, while avoiding secondary insults to the brain, are not clearly identified. Protective ventilatory strategy has been positively evaluated first in patients with ARDS, and then in those undergoing cardiopulmonary bypass or lung resection surgery, or in brain death organ donors, but data on the effect of protective mechanical ventilation on patients with acute brain injury are still lacking even if this is a population with recognized risk factors for ARDS. Therefore, the primary aim of this multi-center, prospective, randomized, controlled trial is to investigate whether a protective ventilatory strategy, in the early phase after severe acute brain injury, is associated with a lower incidence of ARDS, avoiding any further damage to the brain. Secondary aim is to evaluate if a protective ventilatory strategy is associated with reduced duration of mechanical ventilation, incidence of organ failure, intensive care unit length of stay, and lower concentrations of plasma inflammatory cytokines, without adversely affect in neurological outcome.

NCT ID: NCT01628003 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Study of Reserves After Traumatic Brain Injury

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

It is hypothesized that the long-term results of rehabilitation and subsequent aging after Brain Trauma depend on brain's premorbid anatomical (structural) and functional (cognitive, emotional) reserves. The purpose of this study are: 1. to determine whether such reserves exist. 2. to study their convergent and discriminant validity. 3. to study their characteristics.

NCT ID: NCT01417468 Active, not recruiting - Clinical trials for Traumatic Brain Injury

How Well do Patients With Traumatic Brain Injury Learn New Material Using Learning Styles in Online Science Classrooms?

CVD
Start date: May 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether learning styles are effective in the treatment of traumatic brain injury (TBI) in an educational environment.

NCT ID: NCT01207050 Active, not recruiting - Insomnia Clinical Trials

Effect of Rozerem on Sleep Among People With Traumatic Brain Injury

Start date: September 2010
Phase: Phase 4
Study type: Interventional

This pilot study proposes to examine the effect of Rozerem on sleep/wake patterns among individuals with Traumatic Brain Injury (TBI) experiencing sleep disturbance, using both objective and subjective measures. It will also show that improvement in sleep/wake patterns resulting from Rozerem will impact daytime functioning using objective and subjective measures.

NCT ID: NCT01138020 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI)

CRbTBI
Start date: March 1, 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the efficacy of a structured rehabilitation program on cognitive function and quality of life in individuals with blast-induced traumatic brain injury (bTBI).

NCT ID: NCT01072006 Active, not recruiting - PTSD Clinical Trials

Top-Down Executive Control in Traumatic Brain Injury (TBI), PTSD and Combined

Start date: June 2011
Phase: N/A
Study type: Observational

This research investigates processes involved with one being able to focus on relevant information and ignore non-relevant information in veterans with PTSD and those with a history of traumatic brain injury. In addition, this study evaluates whether there is an additive effect of having both PTSD and history of TBI on ability to focus attention and inhibit distracting information.

NCT ID: NCT01068522 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Study to Improve Outcomes for Survivors of Traumatic Brain Injury in Latin America

Start date: July 2007
Phase: Phase 3
Study type: Interventional

People who survive severe traumatic brain injury (TBI) live with profound cognitive impairments that alter their developmental course and define their future possibilities. Worldwide, TBI is the leading cause of death and disability among children and adolescents (Murgio, 2000). In the United States, the annual incidence of TBI is six times greater than that of multiple sclerosis, HIV/AIDS, spinal cord injury, and breast cancer combined [Centers for Disease Control, American Cancer Society, National Multiple Sclerosis Society]. The burden of TBI may be even greater in developing countries, due to civil unrest and war, and to the absence of mandated prevention such as seat belt laws. The long-term objective of the investigators' research group is to improve outcomes for survivors of TBI in Latin America. To that end, the investigators have created a structure for professionals and institutions involved in the treatment of TBI to generate research; to facilitate education, standardization, certification, the dissemination of information and resources; and to foster the development of evidence-based guidelines. The structure is the Latin American Brain Injury Consortium (LABIC).

NCT ID: NCT01013870 Active, not recruiting - Clinical trials for Post-traumatic Stress Disorder

Mission Connect Mild Traumatic Brain Injury (TBI) Integrated Clinical Protocol

Start date: February 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to improve the ability to diagnose problems after mild traumatic brain injury (MTBI) and to test a drug that may improve the outcome from these injuries. Of the more than 1.5 million people who experience a traumatic brain injury (TBI) each year in the United States, as many as 75% sustain a mild TBI which can cause long-term or permanent impairments/disabilities in a significant proportion of patients. In addition, traumatic brain injury has become a signature injury of the wars in Iraq and Afghanistan. For people with these injuries, it is difficult to determine whether symptoms are due to the head injury or another condition, such as Post-traumatic Stress Disorder. In this project, there are 3 observational studies that involve testing of mental functions and behavior, imaging of the brain with special x-ray procedures, and blood samples to look at glandular function, which may be affected by head injury. A fourth study is a test of a drug, atorvastatin, which may provide protection for injured brain cells and improve outcome. By collecting and analyzing the information from these tests, it will be possible to make the process of diagnosing mild TBI or post traumatic stress disorder (PTSD) more precise, and also to see if atorvastatin is a helpful drug for patients with MTBI.

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.