1,308 Clinical Trials for Various Conditions
The purpose of this study is to evaluate the effectiveness of NeuroResource Facilitation, a novel/innovative intervention, in reducing recidivism in offenders with brain injury (BI).
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").
After injury, survivors of msTBI depend on informal family caregivers. Upwards of 77% of family caregivers experience poor outcomes, such as adverse life changes, poor health related quality of life, and increased depressive symptoms. Caregivers frequently report minimal support or training to prepare them for their new role. Periods of care transitions, such as ICU discharge, are most difficult. The majority (93%) of previously developed caregiver and caregiver/survivor dyad interventions after msTBI focus on providing information or practical skills to either survivors, or to long-term caregivers (\>6 months post injury), rather than education, support, and skill-building that the new caregiver may use proactively that will benefit the dyad acutely after injury. The Aims of this proposal are to: (1) Determine feasibility, satisfaction, and data trends of CG-Well; and (2) Understand how baseline psychosocial risk factors affect response to CG-Well compared to an Information, Support, and Referral control group. To accomplish this, I will first enroll 6-10 caregivers and tailor CG-well until each finds the intervention acceptable, appropriate, and feasible. I will then enroll 100 (50/group) dyads and determine satisfaction ratings, recruitment, retention, and treatment fidelity of CG-Well. Additionally, I will determine if caregivers report reductions in depressive symptoms and improvements in life changes as a result of improvements in task difficulty and threat appraisal in CG-Well compared to ISR at six months. Information obtained in Aims 1 and 2 will be used to plan a larger Phase III trial of CG-Well. Completing these Aims and the training plan will improve outcomes of caregivers and downstream outcomes of survivors of msTBI, and provide me with the skillset necessary to become an independent researcher who can develop and test high-impact, high-fidelity, sustainable interventions.
The purpose of this study is to determine whether a course of daily manual lymphatic drainage over the course of 5 days can improve lymphatic drainage function and cognitive outcomes and to determine whether single sessions of manual lymphatic drainage improves lymphatic drainage in moderate to severe traumatic brain injury (TBI) patients.
The purpose of this study is to examine the combined effects of hypoxia and a short bout of subconcussive head impacts on neurocognitive and ocular-motor function and plasma expression of brain-derived blood biomarkers.
ICAN is the first treatment to target hostile attributions after TBI, making it a novel anger/ aggression management approach in this population. This is a randomized waitlist control trial. The length of time in the trial is approximately 15 weeks and the intervention is 6 weeks long.
This study evaluates the effect of a physical exercise + caregiver skills training on feelings of burden, mood, and biological markers of inflammation in persons who provide care for Veterans with a TBI or dementia. Half of the caregivers will participate in a balance and flexibility + caregiver skills training program, while the other half will participate in a moderate/high intensity aerobic and resistance + caregiver skills training program.
The investigators will conduct an observational crossover study. The investigators aim to recruit 50 participants with severe Traumatic Brain Injury (TBI) requiring intracranial pressure (ICP) monitoring during their stay at the Neuro Trauma ICU at the R Adams Cowley Shock Trauma Center. Overall, participants will be monitored, on average, for approximately 6-8 hours during the study period. The investigators do not anticipate the need for prolonged monitoring during the duration of their hospital stay or post hospital period.
Early prediction of outcomes after acute brain injury (ABI) remains a major unsolved problem. Presently, physicians make predictions using clinical examination, traditional scoring systems, and statistical models. In this study, we will use a novel technique, "SeeMe," to objectively assess the level of consciousness in patients suffering from comas following ABI. SeeMe is a program that quantifies total facial motion over time and compares the response after a spoken command (i.e. "open your eyes") to a pre-stimulus baseline.
To assess the impact of a 12-week virtual seated physical intervention on cardiovascular health and wellness in people with chronic neurological impairments (CNI).
Using a retrospective review of records, we will conduct a multivariate analysis to examine the relationship between exposure to ketamine, as an analgesic agent in combat related trauma care, the use of additional opioid pain medications, and patient reported pain levels.
The FBRI VTC Neuromotor Research Clinic was established and opened in May of 2013 to provide intensive therapeutic services to individuals with motor impairment secondary to neuromotor disorders. It is direct by Dr. Stephanie DeLuca and based on the principles surrounding ACQUIREc Therapy. ACQUIREc Therapy is an evidenced-based approach to pediatric constraint-induced movement therapy, which refers to a multi-component form of therapy that is focused on helping children who have asymmetric motor abilities between the two sides of the body. Historically, ACQUIREc Therapy has the unimpaired or less impaired upper extremity constrained (by a cast or a splint) while also receiving active therapy from a specially trained therapist who shapes new skills and functional activities with the child's more impaired upper extremity but who is also a licensed Occupational or Physical Therapist (OT/PT). Therapy dosages are high much higher than tradition OT or PT - often lasting many hours per day, up to 6 hours a day, 5 days a week, for 2-4 weeks. Investigators have developed further treatments based on the same principles of intensive services combined with behavior shaping for other areas of the body that are also affected by weakness (e.g., the leg and trunk) also, but which usually do not involve constraint. These have been more generally labeled ACQUIRE Therapy. All forms involve intensive, play-based therapy for children with asymmetric motor impairments of the arms and hands. The primary focus of treatment is to facilitate the acquisition of new motor skills in the child's weaker body parts through high levels of intensive therapy using scientifically-based behavioral guidelines. Therapy is also delivered in naturalistic environments. ACQUIREc Therapy as a treatment method has been tested in two randomized controlled trials, and a specific manual for its implementation has been developed. Dr. (s) Ramey and DeLuca previously founded a similar clinic, The Pediatric Neuromotor Research Clinic, at the University of Alabama at Birmingham where Dr. DeLuca directed the research clinic for 13 years and oversaw the implementation of the ACQUIREc Therapy treatment protocol in more than 400 cases. This research will involve analyzing and interpreting the clinical data of children going through clinical procedures at the FBRI VTC Neuromotor Research Clinic. All participation is voluntary and no children will denied services if families choose not to participate.
Screening Brain magnetic resonance imaging (MRI) with Fluid-attenuated Inversion Recovery (FLAIR) and Susceptibility Weighted Imaging (SWI) sequences will be performed pre and post season on high school football players. One set of players will wear the Guardian Cap on their five star rated helmets and the other will wear five star rated helmets only. The investigators will compare outcomes of ImPACT scores and MRI findings between the two groups to see if there is a statistical difference in reduction of injury and to establish what the baseline level of MRI findings related to injury from high school football is as well as what the baseline level of injury is prior to the start of the season.
The purpose of this study is to determine whether learning styles are effective in the treatment of traumatic brain injury (TBI) in an educational environment.
The purpose of this research is to evaluate the potential benefits of two Intervention programs in adults with TBI to improve well-being and other outcomes that are maintained over time.
Many Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn era Veterans have suffered a mild traumatic brain injury (mTBI), and now cope with multiple post-injury symptoms, including sleep disturbances (especially insomnia). Chronic insomnia in mTBI patients has the potential to exacerbate other symptoms, delay recovery, and negatively affect many of the cognitive, psychological, and neuromuscular sequelae of mTBI, thereby decreasing quality of life. Although Cognitive-Behavioral Therapy for Insomnia (CBT-I) has been shown to be an effective evidence-based treatment for insomnia, there are no published randomized controlled trials evaluating the potential strengths and/or limitations of CBT-I in post-mTBI patients. Therefore, assessing CBT-I in the context of mTBI holds promise to provide substantial benefits in terms of improved rehabilitation outcomes in Veterans who have suffered mTBI.
By studying individual biomarkers in body fluids such as saliva, there is a potential for detecting injury to the brain resulting from an acute traumatic even that may not be detectable by conventional neuroimaging like CT scans.
The purpose of this study is to determine the effectiveness of the ANSWERS- VA intervention (Acquiring New Skills While Enhancing Remaining Strengths for Veterans) while also determining it's cost effectiveness in the stroke and traumatic brain injury (TBI) populations.
Blast-related and blunt traumatic brain injury is a key priority area of Rehabilitation Research \& Development (RR\&D) and represents a critically important public health problem facing the Veteran population. Developing efficacious treatments for persistent memory deficits seen in this population is a key step in reducing the impact that such problems have in the everyday lives of Veterans. Memory problems after TBI in Veterans are quite heterogeneous, and efficacy will likely be maximized by developing and disseminating multiple alternative treatments individually matched to the Veteran's key deficits, and by research that seeks to understand the cognitive and neural basis of treatment-related change over time. The results of this approach may aid clinical decision making and assignment of patients to rehabilitative treatments most likely to improve memory capacity and functional outcome.
Evaluation of the impact (on survival and other outcomes) of implementing the Brain Trauma Foundation/National Association of EMS Physicians Traumatic Brain Injury (TBI) guidelines in the prehospital EMS systems throughout the state of Arizona.
Neurological complications from cardiac surgery are an important source of operative mortality, prolonged hospitalization, health care expenditure, and impaired quality of life. New strategies of care are needed to avoid rising complications for the growing number of aged patients undergoing cardiac surgery. This study will evaluate novel methods for reducing brain injury during surgery from inadequate brain blood flow using techniques that could be widely employed.
Traumatic brain injury (TBI) is among the leading causes of trauma death and disability in both civilian and military populations. The damage that occurs at the instant of trauma cannot be modified; the secondary injuries that occur afterward are the impediments to recovery and can be influenced by the physician. Cerebral ischemia is the most important secondary event that determines outcome following TBI. To minimize ischemic episodes once the patient has arrived at the hospital, most treatments are aimed at optimizing cerebral perfusion pressure (CPP). The cornerstones of these treatments include mannitol, to reduce intracranial pressure (ICP), and catecholamines, such as phenylephrine (PE), to increase mean arterial pressure (MAP), but these agents have undesired side effects. Nevertheless, once they lose potency, there are few alternatives. The main objective of this proposal to develop a new therapeutic option for CPP management in TBI patients using arginine vasopressin (AVP). AVP is the endogenous anti-diuretic hormone. It is FDA-approved for use in the diagnosis and treatment of diabetes insipidus, for the prevention and treatment of post-operative abdominal distention, and in abdominal radiography to dispel interfering gas shadows. It has been used off-label for several other conditions. There is minimal information on its therapeutic potential after TBI. The investigators have demonstrated that AVP during fluid resuscitation rapidly restored hemodynamics, CPP, and improves acute survival in a clinically-relevant model of TBI. The investigators observed similar short term benefits after chest and liver trauma. Nevertheless, AVP has actions that could mask any short term benefit. The investigators have already defined risks and benefits of AVP therapy, relative to PE, in four different clinically-relevant laboratory model. The investigators now plan to evaluate this new therapy relative to the current evidence-based guideline for CPP management in TBI patients. The working hypothesis is that the risk/benefit profile for AVP is equal, or superior to, PE at equi-effective doses for the management of CPP following TBI. A corollary is that a higher CPP can be safely tolerated with AVP vs catecholamines. THE INVESTIGATORS AIM TO: Determine whether AVP is safe and effective to maintain CPP = 60 mm Hg in TBI patients.
Severe traumatic brain injury (TBI) is associated with a 20-30% mortality rate and significant disability among most survivors. The Centers for Disease Control and Prevention (CDC) estimate that 2% of the U.S. population lives with disabilities directly attributable to TBI, with annual costs exceeding $76.5 billion. Current treatments are largely ineffective because they are instituted after irreversible damage has already occurred. By the time intracranial pressure (ICP) increases or brain tissue oxygen tension (PbtO2) decreases to harmful levels, it is often too late to reverse or repair the damage. A computerized method has been developed that can predict these injurious events ahead of time, allowing clinicians to intervene before further damage occurs. The goal of this proposal is to test these predictions in real time. The first phase of the project (Year 1) involves setting up the informatics infrastructure, with no patient interaction. In the second phase (Year 2), subjects, through surrogate decision-makers, will be enrolled in an observational study where data on intracranial pressure and brain tissue oxygen tension will be collected, and the prediction algorithm will be tested for accuracy. Clinical management will follow standard care protocols, and no additional interventions will be performed. Approximately 120 individuals will participate in this study at the University of Chicago and Ben Taub General Hospital in Houston. Data collected will include both the electronic medical record and data from bedside intensive care unit monitors. The electronic medical record includes demographic information, injury characteristics, laboratory values, and imaging data, while the intensive care unit monitor provides real-time vital signs such as intracranial pressure, brain tissue oxygen tension, and mean arterial pressure. These data will be securely stored in a research computer database. Efforts will be made to contact subjects or their caretakers at 6 months to follow up on recovery. This research aims to improve patient outcomes by providing predictions of further brain injury, with the potential for future interventions to prevent permanent brain damage.
Patients evaluated at Penn Presbyterian Medical Center for traumatic brain injury (TBI), who sign the informed consent, will undergo assessment of electrophysiologic potentials evoked by transcranial magnetic stimulation (TMS), using the Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel).
The purpose of this study is to evaluate the effect of transcranial photobiomodulation (tPBM) in older patients with chronic traumatic brain injury (TBI). The study aims to examine the effect of tPBM on prefrontal cerebral blood flow (CBF) and executive function (EF)
The goal of this clinical trial is to determine which crystalloid (saline or balanced) should be used in the critical management of Traumatic Brain Injury (TBI) in moderate or severe TBI patients. This trial will determine whether the use of saline or balanced crystalloids is associated with improved outcomes in TBI patients. Participants will 1. be given fluids through the veins, either saline or balanced fluid will be given. 2. From the first day to the day 14 of the hospitalization (or discharge, whichever comes first), vital signs, laboratory values, treatments given, and other medical data will be collected from the medical record. 3. Six months later, your final disability, if any, will be assessed during your follow-up with a doctor. It involves answering a short survey that will take about 5 minutes or less.
The primary objective of this study is to establish if Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) are predictive of computed tomography (CT) findings in pediatric traumatic brain injuries (TBI). The participant population is pediatric patients, ages 0 to less than 18 years old with a possible TBI or trauma-related injury who have blood drawn per standard of care in the emergency department. Blood samples will be analyzed using the i-STAT TBI cartridge (Abbott Laboratories, Abbott Park, IL, USA) by the Emergency Department charge nurse within one hour of collection of the blood sample. Clinical outcomes will be assessed via telephone interview with a parent at 3 and 6 months for all surviving TBI patients.
The use of Hyberbaric Oxygen Therapy (HBOT) would be a new treatment plan rather than conventional rest. If effective, this new use technology would add to the clinical treatment among mild traumatic brain injury (mTBI) patients. The use of a point of care Glial Fibrillary Acidic Protein (GFAP) biomarker would aid in clinical decision making to create a new care plan of return to sport among unarmed combat athletes who suffer from mTBI. The innovation would be a new treatment and diagnosis strategy that will protect these athletes from serious long-term sequelae. There are no published randomized controlled studies using HBOT to treat concussed athletes within one week of injury. There are no published studies using GFAP levels to predict post concussive symptoms (PCS).
The two goals of the proposed study are: (1) To determine how brain activity changes with cognitive recovery over time from acute to chronic phases of traumatic brain injury (TBI). (2) To determine how the time of anodal transcranial electrical stimulation (A-tES) administration affects cognitive performance and brain activity in TBI. To achieve these study goals, the investigators will conduct a pilot clinical trial over three years in which the investigators aim to recruit 60 patients with moderate to severe TBI at the University of Cincinnati Medical Center (UCMC). During the acute phase of TBI, all participants will complete clinical questionnaires and perform 2 cognitive computer tasks while their brain activity is recorded. Half of the participants will be randomly selected to receive A-tES for 15 minutes while performing cognitive tasks and the other half will receive sham stimulation. All participants will be followed for 6 months. During their 3-month follow-up, the investigators will perform another session where all participants complete the questionnaires and receive A-tES while performing cognitive tasks during brain recording. In their last visit at 6 months post-injury, all participants will complete the questionnaires and cognitive tasks with brain recording but no stimulation treatment. From the collected data, the investigators will determine if time from brain injury correlates with brain activity during performance of cognitive tasks. The investigators will also assess the efficacy of early A-tES treatment for improving cognitive task performance and clinical test ratings at 6 months post-injury in comparison to A-tES delivered during the 3-month follow-up visit.
The objective of the study is to conduct a randomized controlled trial of Cognitive Behavioral Therapy for Insomnia (CBT-I) in a sample of active-duty sailors with a history of traumatic brain injury (TBI). The investigators will test the impact of CBT-I on insomnia symptoms as well as post-concussive symptoms, psychological symptoms, and neurocognitive functioning in comparison to treatment as usual. The investigators will also compare the effectiveness of traditional in-person CBT-I and CBT-I delivered via a clinician-supervised digital health platform, Clinician Operated Assistive Sleep Technology (COAST) in comparison to treatment as usual on symptoms of insomnia, post-concussive symptoms, neurocognitive functioning, and psychological health. Participants will be assessed at baseline, post-treatment, and 3 months later.