View clinical trials related to Neurobehavioral Manifestations.
Filter by:The purpose of the study is to determine the effectiveness of the helmet-less tackling training (the HuTT Technique) intervention to reduce head impacts in high school football players and to gain an understanding of the neurocognitive effects of repetitive head impacts in football. The investigators hypothesis is that the HuTT Technique will result in a reduced frequency and magnitude of helmet impacts than the control group measured by a head impact measurement system. Also, the investigators hypothesize the HuTT Technique group will demonstrate less changes in neurocognitive scores in the mid and post season evaluations compared to the control group. Head impacts will be measured using the SIM-G impact monitor made by Triax Technology. The SIM-G impact monitor measures the location, magnitude, and direction of every head impact in real time and is stored on a protected cloud-based system. The sensor is worn by each athlete in a headband or skullcap. Neurocognitive function will be measured using the Immediate Post-concussion Assessment and Cognitive Testing (ImPACT) test. The test is used as a tool to determine baseline neurocognitive function and is used in comparison if an athlete was to be injured to ensure he/she returns to baseline. ImPACT measures memory (verbal, visual, working), processing speed and reaction time using a variety of tests. Subjects will be recruited from local high school football teams and will include freshman, sophomores and juniors. Since the study is expected to run for 2 years, seniors will not be eligible for participation. The target is to recruit at least 150 total subjects. All subjects will be equipped with a new helmet that is fitted to their head and a headband that will be used to hold the head impact telemetry sensor. In addition, all subjects will take an ImPACT test preseason, midseason and postseason. At the conclusion of each season, all of the impacts from the SIM-G impact monitor system and ImPACT test scores will be analyzed. The relevant outcome measures to be analyzed include head impact frequency, location, magnitude, symptom scores, memory, visual motor speed and reaction time composite scores. Statistical analysis will be used to determine if the HuTT intervention minimized head impacts and neurocognitive decline compared to the control group.
A Blind-adjudication Multi-center Phase II Randomized Clinical Trial of Continuous Low-dose Intravenous Heparin Therapy in Coiled Low-grade Aneurysmal Subarachnoid Hemorrhage Patients with Significant Hemorrhage Burden. - STUDY IS TEMPORARILY SUSPENDED WITH PLAN TO RESUME SOON. NO SAFETY CONCERNS
The purpose of the study is to describe the association/correlation between change in patient-reported cognitive symptoms and work productivity in gainfully employed patients receiving vortioxetine for a Major Depressive Episode (MDE).
Atrial fibrillation is a common arrythmia. It is an independent risk factor for stroke. There for anticoagulation therapy is used for atrial fibrillation patients. Alternatively, left atrial appendix closure can be used, if the risk for bleeding complications is deemed greater than the possible antithrombotic benefit of anticoagulation medication. Up to 70% of ischemic complications can be prevented with anticoagulation therapy, and left atrial appendix closure seems to have comparable results. Also left atrial catherter ablation (LACA) is gaining popularity as a therapeutic intervention for atrial fibrillation. However, the procedure is associated with 0,5-1% perioperative risk of clinically evident transient ischemic attack (TIA) or stroke. While the incidence of clinically evident ischemic complications remain relatively low, recent data suggest that 13%-20% of patients undergoing LACA are affected by post-operative neurocognitive dysfunction (POCD) 90 days after ablation. The goal of the study is to improve detection of subtle brain dysfunction after cardiac interventions by employing an experimental executive reaction time (RT) test along with EEG recording in aims to improve objective detection of subtle brain dysfunction assumed to underlie persistent cognitive, somatic, and affective complaints reported by patients who have undergone atrial fibrillation ablation.
The purpose of this study is to contribute evidence towards the potential to improve cognition in HIV+ individuals experiencing cognitive decline through personalized change in antiretroviral (ARV) medication. To that end, following a comprehensive evaluation to identify confounding clinical conditions, study participants will undergo a lumbar puncture to: (i) measure viral load (at 2 copies/ml); (ii) identify Cerebrospinal Fluid (CSF) genotype and tropism; and (iii) measure concentration of antiretroviral agents. When indicated from the CSF analysis, a personalized change in ARV will be implemented. Cognition will be measured in all at study entry and 6 months later.
Randomized, double-blind clinical trial of tocilizumab vs. placebo as add-on treatment for residual positive, negative, and cognitive symptoms in schizophrenia. The primary study hypothesis is that individuals receiving tocilizumab will show greater improvements in their PANSS total scores than those taking placebo.
Up to 50% of patients undergoing surgical aortic valve operation suffer from some level of post-operative cognitive dysfunction (POCD). Frontal lobes of the brain, where executive functions are located, are highly susceptible to trauma caused by possible blood malperfusion to these areas of the brain during surgery. Conventional and established neuropsychological test methods are poor in distinguishing these kinds of trauma, as they are isolated, structured tests that do not require multitasking and processing of multiple stimuli at the same time. The phase 1 goal of this study is to employ an experimental Executive reaction time (RT) test to see if this method could improve objective detection of subtle brain dysfunction assumed to underlie persistent cognitive, somatic, and affective complaints reported by patients who have undergone electic aortic valve replacement (AVR) surgery. Phase 2 of the study will concentrate on patients undergoing transcatheter aortic valve implantation (TAVI).
The purpose of this study is to learn if an experimental treatment can help thinking ability, and memory in Veterans with Gulf War Veterans Illnesses (GWVI). The experimental treatment uses light-emitting diodes (LEDs), that are applied outside the skull, to the head using a helmet that is lined with near-infrared diodes. LEDs are also placed in the nostrils (one red diode; and one near-infrared diode), near-infrared photons to the olfactory bulbs located on the orbito-frontal cortex. There are connections between the olfactory bulbs and the hippocampus. A treatment takes about 30 minutes. The participants receive a series of LED treatments which take place as outpatient visits at the VA Boston Healthcare System, Jamaica Plain Campus. The FDA considers the helmet LED device used here, to be a non-significant risk device. The diodes in the device placed in the nose are low-risk devices, within the FDA Category of General Wellness. In addition, a single, 90 mW near-infrared (NIR) LED was placed on each ear. The LEDs do not produce heat.
The investigators overall research hypothesis is that systemic chemotherapy induces structural changes in the white matter of the brain as demonstrated with Diffusion Tensor Imaging (DTI) and functional changes in well-defined cortical neural networks as demonstrated by resting-state functional connectivity MRI (rs-fcMRI). The investigators believe these structural and functional changes are responsible for the cognitive symptoms associated with chemotherapy-induced cognitive impairment (CICI). The Specific Aim for this study is: To assess the impact of chemotherapy on structural white matter as defined by DTI and functional cognitive networks as defined by rs-fcMRI by comparing a sample of breast cancer survivors with self-reported CICI to breast cancer survivors without CICI. Hypothesis: Post-chemotherapy breast cancer patients with self-reported CICI will have abnormal structural connections characterized by DTI-defined disruptions in fractional anisotropy (FA) and mean diffusivity (MD) and abnormal functional connectivity characterized by rs-fcMRI-defined disruptions in cognitive networks when compared to patients without self-reported CICI.
Many patients with celiac disease complain of neurocognitive symptoms such as mental confusion, grogginess, difficulty with concentration and forgetfulness after exposure to gluten. However, there is little data on any possible association between impaired cognitive function and gluten intake in celiac disease. The investigators predict that patients with celiac disease, when exposed to gluten, will experience neurocognitive symptoms such as confusion, forgetfulness and difficulty concentrating. The goals of this study are to determine the prevalence of neurocognitive symptoms after exposure to gluten in patients with celiac disease and to characterize the nature of these symptoms both in terms of their duration and severity.