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Traumatic Brain Injury clinical trials

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NCT ID: NCT00973999 Withdrawn - Clinical trials for Traumatic Brain Injury

Botulinum Toxin and Saliva Management in Tracheotomised Patients

Start date: September 2009
Phase: Phase 2
Study type: Interventional

TITLE A randomised placebo controlled trial to explore the effectiveness of Botulinum Toxin injection at reducing oral secretions and frequency of tracheal suctioning in tracheotomised patients. DESIGN Randomised controlled single blinded experimental design AIMS The purpose of this study is to determine if ultra-sounded guided injections of Botulinum Toxin into the salivary glands (Parotid and sub-mandibular glands) of patients with a tracheostomy tube in-situ assists in the reduction of oral secretions. OUTCOME MEASURES Amount of saliva production / frequency of tracheal suctioning / questionnaires. POPULATION In-patients at the Wellington Hospital based in London will be invited to participate within the study. Participants will be recruited from a range of wards which will include the Intensive Treatment Unit (ITU), acute medical wards and rehabilitation wards. All participants will have a tracheostomy tube in-situ and be breathing on room air, without the need for any mechanical ventilation. Participants will be receiving tracheal suctioning to assist in the clearance of saliva to maintain a clear airway. A total of 40 participants will be recruited to the study across a two year period. Each participant will have no prior history of the following: - swallowing disorders - stroke - myocardial infarction - head or neck surgery - respiratory disease - acute or progressive neurological disease - structural abnormalities that could affect swallowing - other medical conditions requiring medication that could affect swallowing. ELIGIBILITY Male and female adults over the age of 18 years TREATMENT Injection of Botulinum Toxin into both pairs of the parotid salivary glands and submandibular glands, using ultrasound guidance DURATION Data collection over a two year period / six weeks for each participant

NCT ID: NCT00973674 Completed - Clinical trials for Traumatic Brain Injury

Resuscitative Endocrinology:Single-dose Clinical Uses for Estrogen-Traumatic Brain Injury

RESCUE-TBI
Start date: July 2009
Phase: Phase 2
Study type: Interventional

Each year in the United States alone, a third of a million persons are hospitalized for traumatic brain injury (TBI), of whom approximately 1/4 die. Most are less than 30 years of age. Not only are the health care costs staggering for both initial care and rehabilitation, but the societal loss in terms of economic impact reaches into the billions of dollars annually in the U.S. alone. Despite advances in neurosurgical interventions and intensive care management, many survivors do not fully recover. A significant cause of this mortality and morbidity is thought due to potentially preventable secondary injury, namely oxidant injury, inflammation, and apoptosis in the penumbra (the area of brain surrounding the primary lesion, which is at-risk, but potentially salvageable), beginning in the first few hours after the severe traumatic event. Despite the current bleak outlook for many of these patients, a series of animal investigations have uncovered a promising solution to the problem of the secondary injury seen in severe TBI and other similar processes, namely the early administration of estrogen, a strong anti-oxidant, anti-inflammatory and anti-apoptotic compound. Based on these encouraging results from animal studies, the investigators hypothesize that early administration of IV Premarin® in patients with severe TBI will safely reduce secondary brain injury, improve neurological outcomes, and improve survival.

NCT ID: NCT00970944 Completed - Clinical trials for Traumatic Brain Injury

Effectiveness of Amantadine Hydrochloride for Treatment of Severe Traumatic Brain Injury (TBI)

Start date: February 2003
Phase: Phase 2/Phase 3
Study type: Interventional

This is a controlled trial of amantadine to improve level of function following severe traumatic brain injury. The purpose of this study is: 1. To determine whether amantadine hydrochloride, given in a dose of 200-400 mg, improves functional recovery from the vegetative and minimally conscious states 2. To determine whether amantadine-related gains in function persist following drug discontinuation 3. To determine the safety profile of amantadine in patients with disorders of consciousness

NCT ID: NCT00957671 Completed - Clinical trials for Traumatic Brain Injury

Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

Start date: November 2003
Phase: Phase 4
Study type: Interventional

Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by GH stimulation testing. Moreover, abnormalities have also been established for the cortisol and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH, thyroid, cortisol).

NCT ID: NCT00940615 Terminated - Clinical trials for Traumatic Brain Injury

The Effect of Aerobic Exercise on Mild Traumatic Brain Injury

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

The current project will examine the effects of aerobic exercise on cognition among a group of veterans who have suffered a mild traumatic brain injury.

NCT ID: NCT00930774 Completed - Clinical trials for Traumatic Brain Injury

Approaches to Auditory Rehabilitation for Mild Traumatic Brain Injury

mTBI
Start date: October 2010
Phase: N/A
Study type: Interventional

Many soldiers returning from their recent service in Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) were exposed to blasts during combat. About 60% of blast-injured soldiers are diagnosed with traumatic brain injury (TBI), with approximately 18% having a mild TBI (mTBI). mTBI is associated with many symptoms, including memory problems, headaches, difficulty concentrating, increased anxiety, and, especially relevant here, reports of difficulty understanding speech in noisy environments and/or when people speak rapidly. While problems understanding rapid speech or speech in noise are associated with hearing loss, many of the OIF/OEF veterans with these complaints have clinically normal hearing. Although there is no physical damage to their ears, these veterans' hearing problems have a negative impact on their quality-of-life and functioning. Thus it is incumbent upon the VA to examine intervention approaches for veterans with normal/near-normal auditory sensitivity and significant complaints of difficulty hearing. Currently, there is no standard-of-care for these veterans other than providing information about hearing, hearing conservation, and the use of communication strategies. Two forms of rehabilitation likely to be more effective than such an informational-counseling approach are: (1) the use of personal miniaturized Frequency modulation (FM) systems, and (2) the provision of auditory training with Posit Science Brain Fitness Program (BFP). Personal FM systems increase the loudness of the speech signal relative to that of the unwanted noise, while the BFP training improves the ability to listen by taking advantage of the brain's ability to change (i.e., neural plasticity). In this study veterans will randomly be selected to receive one of four treatments: (1) FM use alone, (2) BFP training alone, (3) FM+BFP training combined, and (4) informational-counseling. The effectiveness of the interventions will be compared using self-report of hearing functioning on standard questionnaires. Results will contribute to the development of evidence-based intervention approaches for blast-exposed veterans with reported functional hearing difficulties and normal/near-normal auditory sensitivity.

NCT ID: NCT00929448 Completed - Clinical trials for Traumatic Brain Injury

The Predictive Value of Clinical and Immunological Factors in the Development of Pneumonia After Traumatic Brain Injury

Start date: July 2008
Phase: N/A
Study type: Observational

The development of pneumonia and other infections is one of the most common complications of a traumatic brain injury (TBI). Prior studies have also found that patients suffering from TBI also develop immune dysfunction consistent with an immunosuppressed state shortly after the traumatic event. Specifically, it has been shown that patients with a TBI have impaired delayed type hypersensitivity (DTH), cellular immunity and humoral immunity. The humoral arm of the immune system is particularly involved in defending the host against extracellular bacteria and is primarily composed of B-cells, immunoglobulins and complement. Surgery and trauma impair the clonal expansion of antibody producing B lymphocytes causing hypogammaglobulinemia, through a mechanism involving T lymphocytes. In addition, during the systemic inflammatory process, pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-alpha), interleukin 1 (IL-1beta) and interleukin 6 (IL-6) are released. Nuclear factor kappa beta (NF-kB) is a transcriptional regulatory protein that is involved in the expression of proinflammatory cytokines and appears to act at a critical step in the transcription of many proinflammatory genes. The hypothesis of this study is that the hypogammaglobulinemia from the immune dysfunction and the induction of NF-kB from the inflammatory process are, in part, responsible for the development of pneumonia and other infectious complications identified after TBI. This study has two specific aims: The primary specific aim of this study is to determine the association between serum immunoglobulin or NF-kB levels and the development of pneumonia in patients suffering from traumatic brain injury (TBI). The secondary specific aim of this study is to determine the relative contribution of clinical variables such as APACHE II-III Score and Injury Severity Score as compared to immunological variables (serum immunoglobulins and NF-kB) to the development of pneumonia in patients suffering from TBI.

NCT ID: NCT00929045 Completed - Clinical trials for Traumatic Brain Injury

Growth Hormone and Insulin Growth Factor 1 Deficiencies in Children/Adolescents Following Traumatic Brain Injury: The Impact on Growth and Neuropsychological Development

Start date: July 2007
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to look at the relationship between growth hormones, and recovery from a TBI - traumatic brain injury. It is believed that a TBI may interfere with the body's ability to produce growth hormones. These hormones may be needed by the body for growth, mental development and sexual maturation.

NCT ID: NCT00927576 Completed - Clinical trials for Traumatic Brain Injury

PC-Based Cognitive Rehabilitation for Traumatic Brain Injury (TBI)

Start date: July 2009
Phase: N/A
Study type: Observational

The investigators evaluated whether it was possible to improve the measurement of memory, attention, and executive function in patients who have suffered traumatic brain injury through the use of computer-based testing. Note: the original design of the study was altered due to failure to recruit sufficient numbers of patients who were willing to undergo prolonged cognitive training.

NCT ID: NCT00919906 Completed - Stroke Clinical Trials

My Scrivener® - Measuring Effectiveness and Dose Response in Children

Start date: April 2009
Phase: Phase 1/Phase 2
Study type: Interventional

This study will assess whether a computer haptic peripheral device programmed to provide repetitive motion training is as effective as the same repetitive motion training provided by a human being.