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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT01713010 Unknown status - Clinical trials for Traumatic Brain Injury

Study of Variables Related to the Discontinuation of Mechanical Ventilation in Patients With Head Injury

INDEXTBI
Start date: March 2012
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate physiological variables to the decision about the appropriate time to discontinuation of mechanical ventilation in patients with traumatic brain injury. It is expected that these variables are effective in predicting the outcome of weaning from mechanical ventilation.

NCT ID: NCT01712477 Terminated - Clinical trials for Traumatic Brain Injury

A Comparison of Propofol Versus Midazolam to Sedate Critically Brain Injury; Measurement of Cytokine Response and Assessment of Function

Start date: November 2011
Phase: Phase 4
Study type: Interventional

This is a prospective randomized controlled pilot study in traumatic brain injury (TBI) patients who are sedated with either propofol or midazolam to compare the cytokine response and neuropsychological outcomes with and without elevated blood alcohol levels. Sedation is part of the standard treatment in patients with a TBI and has been proposed as a neuroprotective intervention in head-injured patients. Sedative regimens, such as midazolam and propofol, are not standardized and it is unclear whether sedation has a significant impact on recovery and outcome. A review of propofol versus midazolam in mechanically ventilated patients shows evidence that both provide effective sedation but there is lack of data to support one sedative over the other. Cytokines are released in response to tissue injury and act to generate a variety of physiologic responses. The cytokine elevation has been correlated with the extent of tissue injury. This study will compare the cytokine distribution patterns at specific posttraumatic time points in patients with a TBI sedated with either propofol or midazolam. Additional analysis will compare the cytokine response in patients whom had elevated blood alcohol levels with those with normal levels. Neuropsychological testing will also be performed to determine the extent of brain injury and recovery.

NCT ID: NCT01699308 Completed - Clinical trials for Traumatic Brain Injury

Growth Hormone and Brain Functioning After Traumatic Brain Injury

GH
Start date: December 1, 2009
Phase: Phase 1
Study type: Interventional

The current protocol aims to compare the brain-functioning (fMRI & EEG) and white matter structural integrity (DTI) of persons with mild to severe TBI with and without Growth Hormone deficiency during cognitive tasks; and to examine changes in cognitive and motor performance, EEG/fMRI and white matter integrity associated with growth hormone treatment for twelve months using an open-label design in persons with GH deficiency/insufficiency following mild to severe TBI. To meet this aim, we are in the process of screening 40 persons with mild to severe TBI, ages 18-55, who are at least six months post injury. After screening, 10 persons with TBI and GHD (Growth Hormone deficiency) will receive daily rhGH injections titrated to bring their GH levels into the normal range over the course of twelve months. Treatment will be initiated using rhGH (Genotropin). Subjects with TBI and GHD will be assessed at baseline, 6 months, and 12 months with EEG, fMRI and DTI, and neuropsychological measures. 5 persons with TBI who do not have GHD will be assessed at baseline and at 12 months with EEG, fMRI and DTI, and neuropsychological measures.

NCT ID: NCT01695577 Completed - Clinical trials for Traumatic Brain Injury

Vestibular Rehabilitation and Balance Training After Traumatic Brain Injury

VRTBI2012
Start date: January 15, 2013
Phase: N/A
Study type: Interventional

The main aim of this study is to evaluate the effect of vestibular rehabilitation and balance training on patients with dizziness and balance problems after traumatic brain injury.

NCT ID: NCT01691378 Completed - Clinical trials for Traumatic Brain Injury

Window to Hope-Evaluating a Psychological Treatment for Hopelessness Among Veterans With Traumatic Brain Injury

WtoH
Start date: January 2012
Phase: N/A
Study type: Interventional

The purpose of this project is to provide further evidence regarding a groundbreaking psychological treatment for suicide prevention in individuals with moderate to severe traumatic brain injury (TBI), Window to Hope (WtoH). The study will be one of the first five randomized clinical trials (RCTs) internationally to evaluate a psychological treatment for affective distress after TBI and the first conducted in the United States (U.S.) to specifically address suicide risk as an outcome. The current project aims to adapt WtoH for U.S. military personnel/Veterans (expert Consensus Conference, participant total up to 15), implement the intervention in a Veterans Affairs Medical Center (VAMC) (Pilot Groups 1-4, participant total up to 12), and replicate the results from the original trial in this novel context with a larger sample size (n=70 completed protocols [up to 90 recruited]. Deliverables are expected to include an intervention suitable for both dissemination and larger Phase III trials.

NCT ID: NCT01688869 Completed - Clinical trials for Brain Injury, Traumatic

Mild Traumatic Brain Injury Registry

mTBI
Start date: April 2012
Phase:
Study type: Observational

The purpose of the study is to gather information about patients with mild traumatic brain injury in order to develop guidelines for evaluation and treatment.

NCT ID: NCT01687153 Completed - Clinical trials for Mild Cognitive Impairment

A Study of Brain Aging in Vietnam War Veterans

DOD-ADNI
Start date: October 2012
Phase:
Study type: Observational

Traumatic brain injury (TBI) and post traumatic stress disorder (PTSD) are common combat related problems and may be associated with a greater risk of Alzheimer's disease (AD). The purpose of this study is to examine the possible connections between TBI and PTSD, and the signs and symptoms of AD on Veterans as they age. The information collected will help to learn more about how these injuries may affect Veterans of the Vietnam War as they grow older, as well as Veterans of the current wars in Iraq and Afghanistan, who also have these types of combat related injuries.

NCT ID: NCT01681589 Completed - Clinical trials for Traumatic Brain Injury

Relationship Between Attention and Emotional Regulation Post-Traumatic Brain Injury (TBI)

Start date: August 2012
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to investigate the relationship between attention and emotional function post-Traumatic Brain Injury (TBI) in an effort to better understand the cognitive mechanisms of emotional processing in patients with TBI, and explore novel treatment strategies to improve emotional regulation using with transcranial direct current stimulation (tDCS) to modulate activity in the dysfunctional prefrontal-limbic circuits.

NCT ID: NCT01676311 Terminated - Clinical trials for Traumatic Brain Injury

Effects of Huperzine A in Treatment of Moderate to Severe TBI

Start date: December 2013
Phase: Phase 2
Study type: Interventional

We will explore the use of Huperzine A in patients who have sustained a moderate to severe Traumatic Brain Injury. We aim to determine whether Huperzine A, as compared with placebo, would have an effect on memory function after TBI. Additionally, we aim to determine whether use of Huperzine A in these patients can change brain activity (as indexed by EEG and Transcranial Magnetic Stimulation - TMS), and reduce prevalence/frequency of post-traumatic seizures. We also aim to evaluate the safety of Huperzine A in this population as compared with placebo.

NCT ID: NCT01670526 Completed - Clinical trials for Traumatic Brain Injury

Rivastigmine Patch in Veterans With Cognitive Impairment Following TBI

RIVET
Start date: December 2012
Phase: Phase 3
Study type: Interventional

Difficulties with intellectual functioning, particularly memory functions, are common and source of long-term disability after Traumatic Brain Injury (TBI). However, there is very little information about pharmacologic (i.e., medication) treatments targeting these deficits. There are growing data showing brain abnormalities in acetylcholine, the chemical system that manages memory, in TBI. These findings provide the rationale for the use of cholinesterase inhibitors, medications that modulate this system, in TBI patients. As the prevalence of TBI among Veterans of recent military conflicts increases, becoming a "signature injury" of the Iraq and Afghanistan conflicts, it is of utmost importance to the Veterans Health Administration to collect scientific data on the efficacy of pharmacological treatments for intellectual difficulties in TBI patients. This study will evaluate the effects of the cholinesterase inhibitor rivastigmine transdermal patch in Veterans with TBI and posttraumatic memory problems. Results will provide much needed data that will help treat Veterans with TBI.