View clinical trials related to Brain Injuries.
Filter by:In recent years, media attention has focused on the long-term sequelae of repeated concussive episodes in professional athletes. The growing understanding of the damage done by what was once considered a "ding" during a game or match, and the neurologic consequences of "playing through" or returning to play too soon has led to additional interest in and concern for pediatric athletes (18 or under) who experience sports-related concussions during game or practice play. Because it has only been in recent years that the full scope of damage done by repeated concussive episodes has come to light, very little research has been done on treatment of concussion in either adults or children. Brain injuries in children can be especially problematic, as the brain may continue to develop until the child reaches the age of 24 or older, so concussion during this time of development may be particularly damaging. Docosahexaenoic acid (DHA) is an omega-3 fatty acid commonly found in both fish oils and algae. DHA is known to improve development of the eyes and brain in young children. It is thought to be an effective anti-inflammatory and anti-oxidant, and since it occurs naturally and causes very few harmful side effects, it may be a useful compound in the treatment of pediatric concussion. This is a feasibility trial of DHA for the treatment of sports concussion in a pediatric population. The investigators' primary aim is to determine acceptability of randomization for this compound as well as rate of enrollment given our clinical population. The investigators' secondary aim is to examine preliminary outcomes. The investigators hypothesize that subjects who take 2 g of DHA daily for 3 months will see a shorter time to full recovery and return to play and a shorter time to resolve balance disturbance. These are good, albeit unvalidated, clinical indicators of concussive recovery.
The main objective of this study is to describe differential cognitive processing of various stimuli by a population of control subjects and a population of patients with selective cognitive deficits or altered states of consciousness by using dedicated ERP paradigms and high-density EEG picked up system.
What is the CHAMP Study? The CHAMP Study is a multisite clinical trial funded by the National Institutes of Health that is comparing the efficacy of alternative therapies for young children with unilateral spastic cerebral palsy (or hemiparetic cerebral palsy). Children who meet study eligibility criteria at one of the three clinical sites (Roanoke, VA; Charlottesville, VA, and Columbus, OH) will be invited to enroll, and their parents will be provided all necessary paperwork along with informed consent documentation. Assignment to one of the alternative therapy conditions will be random. Participation in the study includes assessment of each child prior to treatment, close monitoring of the child's progress during treatment, and post-treatment evaluation at the end of therapy, as well as, 6 and 12 months later. Parents will have an active role in the project, both observing their child during therapy sessions and then engaging in home-based activities that allow the child to practice and extend new motor skills. There will be no charge for the therapy provided. What are the therapies being tested? In the past decade or so, a new form of therapy for children with hemiparetic cerebral palsy was developed and has shown to produce positive changes in individual children and in small clinical trials (e.g., DeLuca, Echols, Ramey, & Taub, 2003; DeLuca, Echols, Law, & Ramey, 2006; Case-Smith, DeLuca, Stevenson, & Ramey, 2012). The therapy is named Constraint-Induced Movement Therapy (CIMT) and refers to a multi-component form of therapy in which the child 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. Traditionally, CIMT therapy dosages have been high - often lasting many hours per day, 5 days a week, for 4 consecutive weeks. There are important clinical and scientific questions that need to be answered about the effects of different dosage levels and about different types of constraint on the child's more functional (less impaired) arm and hand. This study will be the first that will directly compare different amounts of therapy and different types of constraint to evaluate what "works best" for young children. The therapy is very play-like and engaging for children, and no negative effects of casting or the high dosages have been detected in previous clinical trials. Who is eligible: Children between 2 and 8 years of age with a diagnosis of unilateral spastic cerebral palsy or hemiparetic cerebral palsy. Children must be relatively healthy, not currently receiving Botox (or other similar medications), and able to understand simple communication and instructions. In advance, the treatment will be explained in detail to parents and a written protocol available to share with the child's physician and other current therapist for review. During the one month of treatment, children will not receive other forms of physical or occupational therapy.
Mild traumatic brain injury (mTBI) is a prevalent and costly public health problem with disabling consequences. More than one million civilians with mTBI are treated in US hospitals and emergency departments each year (Faul, et al., 2010). While the exact number is debated, approximately 10-15% of individuals with mTBI will experience prolonged and disabling post-concussive symptoms (Stranjalis, et al., 2008; Ruff and Weyer Jamora, 2009), and 34% will experience a psychiatric illness in the first year after injury (Fann, et al., 2004). In addition, at least 188,270 military service members sustained a TBI from 2000 to mid August 2010, and nearly 77% of these injuries were mild (Defense and Veterans Brain Injury Center, 2010). Many individuals require treatment for resulting mTBI symptoms. The proposed study builds on preliminary research conducted by the investigators to develop and test the effectiveness of a social work delivered education and reassurance intervention for adults with mTBI (SWIFT-Acute) against usual care. The proposed study will assess acceptability and obtain preliminary effectiveness data for an enhanced social work assessment and intervention for adults with mTBI (SWIFT) discharged from the Emergency Department (ED). SWIFT includes early education, reassurance, coping strategies, resources and a brief alcohol use intervention in the ED plus follow up telephone counseling, needs assessment and case management referral to necessary services. The intervention targets cognitive, physical, psychiatric and functional outcomes; specifically, post-concussive symptoms, depression, anxiety, posttraumatic stress disorder, alcohol use, community functioning and successful linkage to community resources. It is hypothesized that SWIFT will be acceptable to patients and that participants in the SWIFT group will report superior outcomes on measures of post-concussive symptoms, depression and anxiety, alcohol use and community functioning and will report increased successful linkages to needed resources when compared to the SWIFT-Acute group. The specific aims of the study are: 1. Implement an innovative social work intervention for adults with mTBI (SWIFT). 2. Assess acceptability of SWIFT using qualitative interviews with participants. 3. Assess preliminary effectiveness of SWIFT compared to SWIFT-Acute alone on reduction or prevention of post-concussive symptoms, depression, anxiety, posttraumatic stress disorder (PTSD) symptoms, and alcohol use, and on improvement of community functioning and successful linkage to community resources. 80 participants will be randomized to receive SWIFT or SWIFT-Acute. Preliminary intervention effectiveness will be assessed using standard measures of post-concussive symptoms, the primary outcome, depression, anxiety, PTSD, alcohol use, and community functioning. A structured survey will be used to assess linkage to community resources.
The objective of this study is to measure the frequency and clinical types of mild cognitive impairment (MCI) or dementia that occur among up to 150 military retirees with and without a history of traumatic brain injury (TBI) among residents of the Armed Forces Retirement Home, Washington D.C. and the Veterans Home of California-Yountville. Investigators will compare the characteristics of dementia in those who have had a prior TBI to the characteristics in those without a history of TBI. It is our hypothesis that the dementia or MCI among those with prior TBI has distinct neuropsychological features that distinguishes it from those with dementia or MCI without a history of TBI.
To identify the changes in the brain following repeated sports-related concussion in men's football, women's soccer, and women's lacrosse college athletes by reviewing the findings of MRI studies that look at the structure of the brain and the appearance of the white matter at baseline, during the acute phase of a concussive injury, and upon completion of collegiate athletic play and correlate these findings with standard clinical measures.
This study is a prospective multi-centre randomized trial to compare the effect of long-term mild hypothermia versus routine normothermic intensive management in patients with severe traumatic brain injury. The primary hypothesis is that the induction of mild hypothermia (maintained at 34-35℃) for 5 days will improve the outcome of patients at six months post injury compared with normothermia.
This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood (UCB) therapy for patients with acquired brain injury.
Protective ventilation (association of a tidal volume < 8 ml/kg with a positive end expiratory pressure) is poorly used in severe brain-injured patients. Moreover, a systematic approach to extubation may decrease the rate of extubation failure and enhance outcomes of brain-injured patients. We hypothesized that medical education and implementation of an evidence-base care bundle associating protective ventilation and systemic approach to extubation can reduce the duration of mechanical ventilation in brain-injured patients.
Our overall goal in this proposed study is to describe the current prehospital trauma triage process for older adult (age≥55) patients with suspected Traumatic Brain Injury (TBI), to identify the effect of certain medications (anticoagulants and platelet inhibitors) on TBI-related need for trauma center services, and to identify novel TBI screening strategies that are feasible for use in the prehospital setting.