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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT01287156 Completed - Clinical trials for Traumatic Brain Injury

Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury

Start date: January 10, 2013
Phase:
Study type: Observational

Background: - The Center for Neuroscience and Regenerative Medicine is working to improve physicians' understanding of brain injury. More information is needed on traumatic brain injury (TBI), especially how well a person recovers from TBI and how the brain changes over time in people with TBI. To conduct this research, the center is sponsoring a number of research studies on TBI and is interested in evaluating individuals with TBI or post-concussive syndrome to determine if they might be eligible for future studies. Objectives: - To develop a pool of individuals with traumatic brain injury and post-concussive syndrome for future research studies. Eligibility: - Individuals at least 18 years of age who have symptoms of or have been diagnosed with traumatic brain injury or post-concussive syndrome and are willing to participate in future studies. Design: - Participants will be screened with an initial telephone interview, and will be asked to come to the National Institutes of Health for an in-person screening visit. - At the screening visit, participants will provide a medical history, have a physical examination and complete a study questionnaire on their TBI and its symptoms, including how the injury occurred, when it occurred, and any previous brain-related injuries. - Subjects may also return for a second visit at the NIH CC if eligible. - Each visit may involve blood samples, an MRI scan, and a series of tests to evaluate brain function. - Participants will also provide contact information to enable researchers to contact them for future studies.

NCT ID: NCT01278316 Completed - Clinical trials for Traumatic Brain Injury

Rural Veterans With Post-traumatic Stress Disorder (PTSD) And Comorbid Mild Traumatic Brain Injury (TBI): A Feasibility Study

Start date: January 2011
Phase: N/A
Study type: Interventional

This study is being conducted to understand whether training in tasks that require perceiving and thinking about things, or cognition, can improve memory in veterans who have been exposed to a blast explosion and have TBI and PTSD. A primary goal of the study is to determine whether it is feasible for veterans who don't live close to a VA to perform this cognitive training at home.

NCT ID: NCT01251367 Completed - Clinical trials for Post-stroke Spasticity

Dysport® Adult Lower Limb Spasticity Follow-on Study

Start date: June 2011
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

NCT ID: NCT01250132 Completed - Clinical trials for Moderate to Severe Traumatic Brain Injury

Ante-hypophyseal Dysfunctions in Children Following Moderate to Severe Traumatic Brain Injuries

Endoc-TC
Start date: October 2010
Phase: N/A
Study type: Interventional

Annual incidence of severe traumatic brain injuries (TBI) varies from 180 to 300 out of 100.000. Mortality or severe sequelae risk is increased 8 fold after a TBI. Studies in adults showed an ante-hypophyseal deficit in 28 to 68 % of patients with a TBI. The most common deficit is Growth Hormone Deficit (GHD); followed by gonadotropic and corticotropic (AdrenoCorticoTropic Hormone (ACTH)) insufficiencies. Thyrotropic deficits (Thyroid-Stimulating Hormone (TSH)) are less frequent. From a pathophysiological point of view, the lesional mechanism responsible for hypopituitarisms would be a damage of hypophyseal vessels or hypothalamic-pituitary vessels. The frequency of pituitary deficits and the potential beneficial effects of replacement therapy on quality of life, tiredness, loss of energy and productivity, justify the systematic detection of the deficits in patients with moderate to severe TBI. Study hypotheses : At the present time, the lack of data in children does not give us the opportunity to affirm that one part of the symptoms showed by children with post-TBI neuropsychological sequelae, are linked to pituitary deficiency and that they can be improved with a replacement therapy. Firstly, it is essential to better understand the natural history of post-TBI pituitary deficiencies, studying the connexion between observed deficiencies in acute and late phase of sequelae.

NCT ID: NCT01225692 Completed - Clinical trials for Craniocerebral Trauma

Brain Trauma Outcomes in Nova Scotia Study

BTOS
Start date: February 2004
Phase: N/A
Study type: Interventional

The goals of this study are to identify outcome indicators of optimal care for brain injury patients, including pre-hospital care, prompt delivery to neurosurgical care and access to early rehabilitation services. Nova Scotia's centralized Neurosurgical services and integrated provincial Emergency Health Services provide a rich opportunity to construct a cohesive, integrated data management system. This system will allow us to answer important research questions related to the outcomes, care and prevention of brain trauma. Retrospective data collection The retrospective arm of the BTO study has created full data sets and care pathways from multiple sources covering the continuum of brain trauma care. Investigators continue to analyze this large amount of data and prepare it for publication. Prospective data Collection Patients with a major head injury (initial GCS 3-12), have been considered for enrollment in the BTO study.The prospective arm of the BTO study has 52 patients enrolled. Screening and Enrollment was complete on June 30, 2007. These patients are participating in long term follow up at 6, 12 and 24 months post injury for assessment of qualitative and quantitative outcomes. Completion of patient follow up will be in June 2009.

NCT ID: NCT01212679 Completed - Clinical trials for Traumatic Brain Injury

Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury

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

Traumatic bain injury(TBI) remains a hidden epidemic involving individuals affected predominantly at a young age who in the most severe cases remain with permanent physical,psychological and cognitive deficits.This study will investigate the therapeutic effects of intranasal Nerve Growth Factor(NGF) in TBI.

NCT ID: NCT01201863 Completed - Trauma Clinical Trials

Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy

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

The purpose of this study was to address 3 short term objectives; (1) Determine the effects of physiologic testosterone (T) therapy on neurological function and functional independence following traumatic brain injury (TBI) in hypogonadal men during inpatient rehabilitation; (2) Document the natural history of neuroendocrine dysfunction and recovery in men during inpatient rehabilitation after TBI; (3) Obtain data to validate the NIH toolbox, a novel assessment of neurological function for use in the TBI population; and 2 long-term objectives: (1) Utilize study findings to design a multicenter trial to further assess the impact of T therapy in hypogonadal men following TBI and (2) Impact TBI practice management with new information about neuroendocrine dysfunction after TBI and hormone treatments to improve outcomes.

NCT ID: NCT01196299 Completed - Clinical trials for Traumatic Brain Injury

Imaging of Traumatic Brain Injury

Imaging of TBI
Start date: March 21, 2010
Phase:
Study type: Observational

This project aims to study the prognostic ability of various MRI imaging markers in the evaluation of TBI patients. Cognitive, social, and occupational recovery will be measured at each time point, and compared to MRI findings. Healthy volunteers will serve as a comparison to the TBI patients. It is hypothesized that novel MRI markers of metabolism, hemodynamics, functional connectivity, and tissue microstructure will be related to the clinical status of the patient, as well as their social and occupational outcomes.

NCT ID: NCT01194661 Completed - Stroke Clinical Trials

Neural Dynamics and Connectivity in Response Inhibition and Traumatic Brain Injury

Start date: August 10, 2010
Phase:
Study type: Observational

Background: - Previous research has shown that certain parts of the brain are involved in voluntarily stopping an ongoing motor response (movement); however, it is not known whether this same network is also involved in suppressing an urge to act. Traumatic brain injury (TBI) can significantly impair the brain's ability to voluntarily stop or inhibit certain actions. Using brain imaging (functional magnetic resonance imaging, or fMRI) and brain stimulation (transcranial magnetic stimulation, or TMS) to investigate how people perform activities that involve moving and suppressing movements, researchers hope to better understand how these brain areas might be affected in people who have had TBI. Objectives: - To determine the parts of the brain involved in suppressing an urge to act. - To determine the extent to which traumatic brain injury affecting certain parts of the brain is involved in problems with suppressing an urge to move and stopping movement. Eligibility: - Individuals 18 to 40 years of age who have had mild or moderate TBI, or are healthy volunteers. Design: - This research study includes a screening visit and two study visits, each of which will last at least 2 hours. - Participants will be screened with a physical examination and medical history. Women who can become pregnant will have a urine pregnancy test before being allowed to participate in the study. - At the first study visit, participants will complete one of the following experiment tests in an MRI scanner. - Experiment 1: Participants will be shown arrows or images on a computer screen, and will press a button or not press a button depending on the image shown. Participants will practice the experiment tasks before performing them during MRI scans. - Experiment 2: Participants will be shown arrows or images on a computer screen, and will press a button or not press a button depending on the image shown. Participants will also have TMS while at rest, and will perform the experiment tasks during the MRI scan. - At the second study visit, participants will have an fMRI scan where they will be asked to do simple response tasks with a computer outside the MRI scanner. Background: - Previous research has shown that certain parts of the brain are involved in voluntarily stopping an ongoing motor response (movement); however, it is not known whether this same network is also involved in suppressing an urge to act. Traumatic brain injury (TBI) can significantly impair the brain's ability to voluntarily stop or inhibit certain actions. Using brain imaging (functional magnetic resonance imaging, or fMRI) and brain stimulation (transcranial magnetic stimulation, or TMS) to investigate how people perform activities that involve moving and suppressing movements, researchers hope to better understand how these brain areas might be affected in people who have had TBI. Objectives: - To determine the parts of the brain involved in suppressing an urge to act. - To determine the extent to which traumatic brain injury affecting certain parts of the brain is involved in problems with suppressing an urge to move and stopping movement. Eligibility: - Individuals 18 to 40 years of age who have had mild or moderate TBI, or are healthy volunteers. Design: - This research study includes a screening visit and two study visits, each of which will last at least 2 hours. - Participants will be screened with a physical examination and medical history. Women who can become pregnant will have a urine pregnancy test before being allowed to participate in the study. - At the first study visit, participants will complete one of the following experiment tests in an MRI scanner. - Experiment 1: Participants will be shown arrows or images on a computer screen, and will press a button or not press a button depending on the image shown. Participants will practice the experiment tasks before performing them during MRI scans. - Experiment 2: Participants will be shown arrows or images on a computer screen, and will press a button or not press a button depending on the image shown. Participants will also have TMS while at rest, and will perform the experiment tasks during the MRI scan. - At the second study visit, participants will have an fMRI scan where they will be asked to do simple response tasks with a computer outside the MRI scanner.

NCT ID: NCT01175993 Completed - Clinical trials for Traumatic Brain Injury

Effects of Rapid-Resisted Exercise and Bright Light Therapy on Ambulatory Adults With Traumatic Brain Injury

Start date: August 24, 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Traumatic brain injury may have a range of effects, from severe and permanent disability to more subtle functional and cognitive deficits that often go undetected during initial treatment. To improve treatments and therapies and to provide a uniform quality of care, more research is needed into different treatments for traumatic brain injury. - Exercise has been shown to improve movement and balance in people with strokes, cerebral palsy, and other conditions that affect the brain, and can improve symptoms of memory problems or depression. Bright light therapy has also been shown to improve mood in people with depression. Researchers are interested in studying problems with movement, balance, thinking, and mood in people with traumatic brain injury. By comparing the effects of exercise and bright light exposure on brain function, new treatments may be developed for acute traumatic brain injury. Objectives: - To compare the effects of exercise and bright light therapy on the brain function of individuals with traumatic brain injury. Eligibility: - Individuals between 18 and 44 years of age who either have been diagnosed with traumatic brain injury or are healthy volunteers. Design: - Individuals with traumatic brain injury will have four outpatient evaluation visits at the clinical center, a 3-month home exercise program, and a 3-month bright light exposure program at home. Healthy volunteers will have one evaluation visit at the clinical center. - At the first study visit, all participants will have a full physical examination and medical history. Individuals with traumatic brain injury will also have an eye exam to determine if it is safe for them to receive light therapy. - All participants will have the following initial tests: - Tests of walking and movement, including monitoring by a physical therapist; tests to record joint movement and evaluate muscle function; tests that combine movement, thinking, and speaking; and balance and reaction time tests. - Magnetic resonance imaging scans - Tests of thinking and mood, including questionnaires, computerized tests, and simple action tests. - Participants with traumatic brain injury will have separate 3-month sessions of exercise and bright light therapy, with additional evaluation visits between each 3-month session and at the end of the study. Between the 3-month sessions, participants will have 1 month with no intervention. - Exercise sessions will involve regular workouts on an elliptical machine for 30 minutes for 5 days a week, and bright light therapy sessions will involve sitting in front of a light box for 30 minutes for 5 days a week. Participants will keep a journal to monitor the effects of the therapy.