Transforming Research and Clinical Knowledge in TBI Pilot
Traumatic Brain InjuryThe global aim of this proposal is to test and refine Common Data Elements (CDEs), neuroimaging standards, and best practices for genetics and proteomics in Traumatic Brain Injury (TBI) studies. Testing and validating of TBI-CDEs will be performed in a multi-center prospective observational study with 3 TBI Centers (San Francisco General Hospital (SFGH), University of Pittsburgh Medical Center (UPMC), University Medical Center Brackenridge (UMCB)) and a TBI Rehabilitation Center (Mount Sinai Rehabilitation Center (MSMC)). The investigators will create and expand existing data repositories for patient demographics, neuroimaging, plasma biomarkers, genetics, and multivariate outcomes thereby providing researchers and clinicians with the infrastructure to establish multidisciplinary, multicenter research networks and improve clinical research in the TBI field.
Functional and Anatomical Magnetic Resonance Imaging (MRI) of Chronic Brain Injury and Hyperbaric...
Brain InjurySequelae3 moreThe purpose of this study is to evaluate Brain MRI (Magnetic Resonance Imaging), and Brain CT (Computed Tomography) Angiogram data in subjects who participate in the "Hyperbaric Oxygen for Chronic Stable Brain Injury" (HYBOBI) study. Including information from MRI and CT studies provide information about whether hyperbaric oxygen improves brain function in subjects who have had a brain injury. Subjects will complete MR and CT scans twice during the study. The first MR and CT will be performed prior to the first hyperbaric session of the HYBOBI study, and the second will be performed within two weeks following the last hyperbaric session.
Electrolyte and Fluid Disturbances in Subarachnoid Hemorrhage and Traumatic Brain Injury
Electrolyte DisturbancesSubarachnoid Hemorrhage2 moreDuring the course of their acute illness patients with subarachnoid hemorrhage and severe traumatic brain injury often develop disturbances in their fluid balance and electrolyte homeostasis. These shifts are associated with worse outcome and increased morbidity. The aim of this observational study is to systematically analyze the incidence, characteristics, potential diagnostic markers and predisposing factors of such disturbances. The investigators hypothesize that many disturbances cannot be classified with a standard diagnostic approach and that variable fluid management contributes to their pathophysiology. Patients will be closely monitored clinically and the exact fluid and electrolyte balances will be recorded. Treatment decisions are within the bedside physicians responsibility. Baseline fluid management is standardised. No interventions are planned. The observation period equal the duration of ICU stay.
Structural and Functional Neuroimaging Studies of Combat Veterans
Traumatic Brain InjuryPTSDBackground: - Studies have shown that some people develop post-traumatic stress disorder (PTSD) after being exposed to the trauma of military combat. They may have repeated thoughts, images, and dreams of the trauma; feel detached from others; have difficulty sleeping and concentrating; or be easily startled. Some studies have also shown that after having a blow or blast to the head, some people may develop post-concussive syndrome (PCS), which may include symptoms such as headaches, difficulty concentrating, and feeling moody or irritable. Researchers are interested in using magnetic resonance imaging (MRI) to study combat veterans from Operation Iraqi Freedom or Operation Enduring Freedom in order to evaluate possible changes in the brain that may be attributed to PTSD or PCS. Objectives: - To evaluate changes in brain function in recent combat veterans that may be related to post-traumatic stress disorder or post-concussive syndrome. Eligibility: - Combat veterans of Operation Iraqi Freedom/Operation Enduring Freedom who are enrolled in Walter Reed Army Medical Center protocol 351030, have returned within the last 6 weeks from a deployment in Iraq or Afghanistan that lasted at least 3 months, and are able to have magnetic resonance imaging scans. Design: This study involves between 1 and 4 outpatient visits to the NIH Clinical Center over the course of 1 year. The second, third, and fourth visits will occur 3, 6, and 12 months after the first visit. At the first visit, participants will have a baseline MRI scan, followed by a functional MRI (fMRI) scan to see what parts of the brain are used while performing simple tasks and responding to images. Participants will complete questionnaires after the scan to report on their experiences during the MRI scan. For the remaining three study visits, participants will have further MRI and fMRI scans and will complete additional questionnaires. Participation is complete after the 12-month study visit, or following a diagnosis of PTSD, major depression, or PCS at any time during the study. No treatment will be provided as part of this protocol.
Neural Dynamics and Connectivity in Response Inhibition and Traumatic Brain Injury
Traumatic Brain InjuryStroke2 moreBackground: - 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.
Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety...
Acquired Bleeding DisorderTraumaThis study is conducted in North America. The purpose of this study is to evaluate the occurrence and severity of bleeding in brain injury and to identify important safety issues following traumatic brain injury.
Approaches and Decisions for Acute Pediatric TBI Trial
Severe Traumatic Brain InjuryApproaches and Decisions in Acute Pediatric TBI Trial (ADAPT) is an international research study designed to evaluate the impact of interventions on the outcomes of children with severe traumatic brain injury. Pediatric traumatic brain injury (TBI) is the leading killer of children, resulting in more than 7000 deaths and $2 billion in acute care costs each year. Despite this large burden of disease, advances in the field have been limited due to weak evidenced-based guidelines and the limitations of randomized, controlled trials (RCTs) to demonstrate efficacy of single treatment strategies due to wide treatment variability. ADAPT is a practical study design in a novel approach - an observational cohort study designed to evaluate the association of 6 aspects of pediatric TBI care with outcomes using statistical modeling to correct for confounding variables. Completion of this study will provide compelling evidence to change clinical practices, provide evidence for new Level II recommendations for future guidelines and lead to improved research protocols that would limit variability in TBI treatments - helping children immediately through better clinical practices and ultimately through more effective investigation.
The Use of LIFUP in Chronic Disorders of Consciousness
Disorder of ConsciousnessVegetative State9 moreWhen patients survive a severe brain injury but fail to fully recover, they often enter a Disorder of Consciousness (DoC) --that is, a set of related conditions of decreased awareness and arousal including the Vegetative State (VS) and the Minimally Conscious State (MCS). When these conditions become chronic, there are no approved treatments to help bolster any further recovery. In prior work, we have shown the clinical feasibility and potential of Low Intensity Focused Ultrasound Pulsation (LIFUP) as a remarkably safe form of non-invasive brain stimulation in these conditions.
Intracranial PrEssure Time dOse (ImPETO)
Intracranial HypertensionTraumatic Brain Injury2 moreThe new Integra CereLink ICP monitor integrate the possibility of recording and displaying continuously the AUC (Pressure Time Dose, PTD) and other ICP derived variables and provide the possibility of evaluating the utility of this information at the bedside. It offers the opportunity to test in a standardized way the clinical value of the PTD computation in this setting. Therefore, this study aims to test clinically if PTD recorded continuously is associated to patients' outcome and to identify a threshold of PTD associated with the transition from good to negative outcomes.
Study Examines the Feasibility, Safety and Benefits of Using a Specific Suspension Walking Device...
StrokeTraumatic Brain Injury2 moreThis monocentric descriptive study addresses feasibility, safety and benefits of using a specific suspension walking device for patients with severe neurological injuries in the neuroICU of Montpellier University Hospital, France. Analyzes are retrospective on data collected prospectively during standard practice. All adult neurological patients hospitalized for > 48 hours and requiring mechanical ventilation from January 2018 to January 2019 are included, and divided into two groups: beneficiaries of suspension walking during the ICU stay, and non-beneficiaries. Characteristics of the two groups are compared and reasons for not using suspension walking recorded (feasibility). After pooling all suspension walking sessions, changes in clinical parameters during sessions and occurrence of adverse events are described (tolerance).