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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT01596569 Completed - Clinical trials for Traumatic Brain Injury

Combined Transcranial Magnetic Stimulation and Cognitive Treatment in Blast Traumatic Brain Injury

COST-TBI
Start date: May 2012
Phase: N/A
Study type: Interventional

This study investigates the efficacy of a novel neurorehabilitation program combining noninvasive brain stimulation (transcranial magnetic stimulation or TMS) and cognitive therapy, on cognitive function and quality of life in individuals with blast-induced traumatic brain injury (bTBI).

NCT ID: NCT01589172 Completed - Clinical trials for Traumatic Brain Injury

Evaluating the Use of Thromboelastography to Diagnose Coagulopathy After Traumatic Brain Injury

Start date: May 1, 2012
Phase:
Study type: Observational

The investigators will obtain thromboelastography (TEG) on pediatric patients admitted to the Rady Children's Hospital ICU after traumatic brain injury on admission to our ICU and after 24 hours of care. The investigators hypothesize that TEG will identify abnormalities of coagulation that are not identified by traditional coagulation studies, i.e. prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR).

NCT ID: NCT01588691 Completed - Clinical trials for Traumatic Brain Injury

Traumatic Brain Injury Peripheral Nerve Study

TBI
Start date: December 2011
Phase: Phase 1
Study type: Interventional

Peripheral nerve stimulation for the treatment of sequelae due to traumatic brain injury. This study will specifically examine patients with mild traumatic brain injury (TBI) who have persistent cognitive impairments lasting one year or longer. Neuropsychological testing will occur to confirm the diagnosis.

NCT ID: NCT01573507 Completed - Clinical trials for Traumatic Brain Injury

Lactate Therapy After Traumatic Brain Injury

LS_TCC
Start date: March 2012
Phase: N/A
Study type: Interventional

Background: Although glucose is essential to cerebral function, abundant experimental and clinical evidence demonstrates that endogenously released lactate, rather than glucose, is the preferential energy substrate for the brain in conditions of stress and acute injury. In patients with severe Traumatic Brain Injury (TBI) and aneurysmal subarachnoid hemorrhage (SAH) monitored with cerebral microdialysis and brain tissue oxygen (PbtO2), our preliminary data show that increased brain extracellular lactate is frequently observed. Our findings indicate that elevated brain lactate more often occurs in the absence of brain hypoxia/ischemia and is mainly the consequence of increased cerebral glycolysis, i.e. it occurs in association with high extracellular pyruvate. These data suggest that the primary source of elevated lactate is activated glycolysis and strongly support the concept that endogenously released lactate can be utilized by the injured human brain as energy substrate. They prompt further investigation to examine whether exogenous lactate supplementation can be a valuable neuroprotective strategy after TBI or SAH. Indeed, in animal models of brain injury, administration of exogenous lactate improves neuronal and cognitive recovery. Hypothesis: The investigators test the hypothesis that lactate therapy, administered during the acute phase of TBI or SAH, might exercise neuroprotective actions by restoring brain energetics and improving brain tissue PO2 and cerebral blood flow (CBF). Aim of the study: The aim of this single-center study is to examine the effect of sodium lactate infusion on cerebral extracellular metabolites, brain tissue PO2 and cerebral blood flow, measured with CT perfusion and transcranial doppler (TCD). Design: Prospective phase II interventional study examining the effect of a continuous 3-6 hours infusion of sodium lactate (20-40 µmol/kg/min), administered within 48 hours from TBI or SAH, on cerebral extracellular glucose, pyruvate, glutamate, glycerol, PbtO2 and CBF.

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: 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: 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").