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Brain Injuries clinical trials

View clinical trials related to Brain Injuries.

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NCT ID: NCT01554891 Completed - Clinical trials for Brain Injuries, Traumatic

INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI)

SAFE-TBI
Start date: February 2012
Phase: N/A
Study type: Observational

The current study will evaluate the initial reliability and validity of a new instrument, the INTRuST Structured Assessment for Evaluation of TBI (SAFE-TBI), in three samples of Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) veterans. The SAFE-TBI is a relatively brief measure developed by INTRuST consortium investigators and designed to be given by a trained administrator. It allows for a determination of the level of evidence for exposure to a mild traumatic brain injury (TBI) using the following categories: Strong, Moderate, Weak, or No Evidence of mild TBI. The first objective is to determine the reliability (both test-retest and inter-rater) in a sample of 100 veterans recently returned from deployment at Joint Base Lewis-McChord and Fort Bragg (Cohort 1), who have screened positive for TBI on the Post-Deployment Health Assessment. The second objective is to determine the concordance between the SAFE-TBI and the VA TBI Screen in 100 OEF/OIF/OND veterans within the Northern New England VA Research Consortium (Cohort 2). The third objective, to be carried out in a sample of 200 Walter Reed National Military Medical Center (WRNMMC) and Fort Belvoir Community Hospital OEF/OIF/OND patients (Cohort 3), is to determine the sensitivity and specificity of the SAFE-TBI using the INTRuST study "Brain Indices of Risk for Posttraumatic Stress Disorder after Mild Traumatic Brain Injury" initial evaluation as the "gold standard" for TBI assessment.

NCT ID: NCT01552473 Completed - Clinical trials for Traumatic Brain Injury

Brain Training to Enhance Frontal Lobe Reasoning

Start date: March 2012
Phase: Phase 2
Study type: Interventional

This study is being done to improve the ability to diagnose and to achieve higher-levels of functional recovery in soldiers and civilians who have suffered either mild Traumatic Brain Injury (TBIs) or moderate-to-severe TBIs at chronic stages of brain recovery (greater than 12 months).

NCT ID: NCT01547780 Completed - Healthy Clinical Trials

Translocator Protein and Inflammation After Traumatic Brain Injury

Start date: January 20, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - People with traumatic brain injury (TBI) often have inflammation in the brain. A protein called the translocator protein (TSPO) is often present with inflammation. Researchers want to see if a radioactive chemical known as [11C]PBR28 can be used to study TSPO and inflammation in the brain of people with TBI. Objectives: - To test whether [11C]PBR28 can be used to study changes in the brain after a traumatic brain injury. Eligibility: - Individuals at least 18 years of age who have had TBI and have had a brain scan that shows signs of inflammation. - Healthy volunteers at least 18 years of age. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. - All participants will have two brain scans during an outpatient visit. A magnetic resonance imaging scan will study brain activity. A positron emission tomography (PET) scan will use [11C]PBR28 to look for signs of TSPO and brain inflammation. - Participants with TBI will have two PET scans within 10 days of the head injury, and a PET scan around 90 days after the injury. They may also have MRI scans under this or another study. Tests of thinking, memory, and concentration will be used to study the effects of the injury and inflammation

NCT ID: NCT01545271 Completed - Clinical trials for Hypoxic Ischaemic Encephalopathy

Xenon and Cooling Therapy in Babies at High Risk of Brain Injury Following Poor Condition at Birth

CoolXenon2
Start date: May 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This study examines the effect of inhaled xenon gas in the treatment of newborn infants with hypoxic-ischemic encephalopathy (HIE) in combination with cooling, which is the standard treatment for this condition. The hypothesis is that the xenon + cooling combination will produce better neuroprotection than the standard treatment of cooling alone.

NCT ID: NCT01535339 Completed - Clinical trials for Mild Traumatic Brain Injury

Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Sport Concussion Assessment - Test Stability and Effect of Concussion

Start date: February 2012
Phase:
Study type: Observational

Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport. Despite ongoing research, there is no highly sensitive clinical test for cognitive function. This makes the clinical diagnosis of concussion particularly difficult as the clinical presentation of concussion is highly variable with symptoms often evolving over time. Given the variability in concussion presentations, there is no single test that can diagnose a concussion. Current recommendations are that sports medicine providers apply a multifaceted concussion assessment battery that combines subjective symptoms, motor control and cognitive assessment. This investigation is designed to evaluate the clinical utility of ElMindA's BNA scores in detecting and managing concussive injuries. This study will establish the reliability of BNA™ scores over clinically relevant assessment intervals and investigate the effect of SRC and sub-concussive head impacts on BNA scores.

NCT ID: NCT01532271 Completed - Clinical trials for Traumatic Brain Injury

Comparison of Brain Network Activation (BNA™) Analysis, Clinical Symptoms and Neuro-cognitive Performance in Concussed Children and Young Adults

Start date: February 2012
Phase:
Study type: Observational

The use of Event Related Potentials (ERP) and neurocognitive performance in patients following concussion has been examined previously in small cohorts and relatively long after concussion occurred. However, little is known about the immediate changes in brain activity in specific brain regions and connectivity across them associated with performance on specific neurocognitive tests following a concussion, and the subsequent changes over time. The proposed study will provide initial evidence for the feasibility of an ERP based biomarker for concussion reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion.

NCT ID: NCT01524822 Completed - Clinical trials for Tramatic Brain Injury

The Effects of Chronic Exposure to Low-Level Blasts

Start date: July 30, 2012
Phase:
Study type: Observational

Background: - Repeated exposure to explosions may lead to changes in the way that people think or feel. Breachers (people trained to use explosives to get into buildings) are exposed to repeated blasts as part of their job. Researchers want to study how they might be affected by blast exposure. Breachers will be compared with other groups who have different levels of exposure to repeated blasts. Information will also be obtained from spouses or close companions. Objectives: - To study the effects of repeated exposure to low-level blasts on thinking, memory, behavior, and brain function. Eligibility: - Experienced military and civilian breachers, experienced active duty artillery operators, and active duty military without frequent blast exposure, 18 and 60 years of age. - Spouses or close companions of these individuals. Design: - Participants will be screened with a physical exam and medical history. Blood samples will be collected and a urine pregnancy test will be required of participants (not companions) before MRI scanning. - Participants will spend up to 5-days as a NIH clinic outpatient, with about 6 hours of tests each day. Tests will include the following: - Medical and professional history, with questions about exposures to blasts - Tests of thinking, memory, and concentration - Balance tests - Hearing tests - Imaging studies, such as magnetic resonance imaging, to look at the brain - Overnight sleep study to monitor brain waves - Blood samples - Participants will return 1 year later for a 3-day followup visit. Some of the tests from before will be repeated. A spouse or close companion (if available) will be asked to complete questionnaires or have a telephone interview....

NCT ID: NCT01516281 Completed - Parkinson's Disease Clinical Trials

Imaging Biomarkers of Delayed Sequelae in Trauma Brain Injury

Start date: March 2012
Phase:
Study type: Observational

The purpose of this study is to learn if a new brain imaging technology called DaTscan can detect subtle changes in the brain that are similar to those seen in early Parkinson's disease (PD). The results of this study may provide more information about a possible association between mild to moderate traumatic brain injury (mTBI) and PD. The objectives of this study are to define and describe a group of approximately 7,122 mTBI subjects and 7,122 subjects without mTBI (mTBI-) seen in the Emergency Rooms of NorthShore University HealthSystem during the years 2006-2011, and to select from willing eligible subjects a random sample of 100 mTBI subjects and 100 mTBI- subjects (of the same age and gender) to undergo written informed consent, neurological examinations, blood drawing for DNA extraction and storage, and DaTscan brain imaging. The investigators will compare the findings from persons who experienced mTBI (cases) to persons without a history of brain injury (mTBI- or "controls").

NCT ID: NCT01515839 Completed - Clinical trials for Traumatic Brain Injury

Single Photon Emission Computed Tomography (SPECT) Imaging Study of Professional American Football Players

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

The investigators primary objective is to acquire preliminary data on one-hundred former NFL veterans with at least one full year of professional service using brain SPECT imaging in order to assess the degree to which NFL football puts players at risk for traumatic brain injury (TBI). TBI severity shall be gauged via visual inspection by a clinician trained in neuroanatomy, and also by a statistical comparison of subjects' brains to an in-house proprietary database comprised of the brains of healthy subjects. The investigators secondary objective is to acquire additional data on these players such that investigators may establish causative factors and risks associated with said TBI. The investigators tertiary objective is to acquire data on subjects using various mental health metrics in order to determine the effects of TBI.

NCT ID: NCT01502852 Completed - Clinical trials for Traumatic Brain Injury

Identifying the Needs of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans and Their Families: TBI and Co-Occurring Behavioral Health Issues

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

The purpose of this study is to explore and potentially increase the capacity of the non-VA community mental health system within the state of Colorado to provide a comprehensive and coordinated service delivery system for Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans and their families. The specific population of interest is OEF/OIF Veterans with a history of traumatic brain injury (TBI) and co-occurring behavioral health issues.