View clinical trials related to Brain Injuries.
Filter by:This study examines the effects of computerbased cognitive rehabilitation on executive functions in the chronic phase after acquired brain injury
The aim of the study is to evaluate the feasibility and safety and efficacy of collecting and infusing autologous umbilical cord blood (UCB) in newborn infants with hypoplastic left heart syndrome (HLHS) and transposition of great arteries (TGA). Rationale: Neonates with HLHS and TGA have significant brain injury as demonstrated by peri-surgical MRI. Moreover, there a substantial tendency to suffer from chronic cardiac condition as low cardiac output state and valvular insufficiency. Treatment of neonates after hypoxic ischemic injury at birth with autologous UCB was shown to safe and improved developmental outcome. The effect of UCB is most likely achieved by reduction of free radicals injury and pro-inflammatory and apoptotic process. Hypothesis: Treatment with UCB immediately after the first cardiac surgey, with in the first week life will reduce the brain injury demonstrated by MRI and reduce the choronic cardiac problems
Patients with a history of mild traumatic brain injury (mTBI) or post acute sequelae of SARS-CoV-2 (PASC) and abnormal growth hormone secretion, as measured by glucagon stimulation test, will be treated with replacement growth hormone therapy for a period of 6 months (mTBI) or 9 months (PASC). Testing of cognition, exercise, fatigue, brain activation and morphology, body composition and measurements of quality of life will be performed before and after the treatment period. Fecal sampling for characterization of the GI microbiome will occur monthly over the treatment period. Control subjects will be enrolled and will provide fecal samples monthly for 6 months. GI microbiomes will be compared between mTBI patients, PASC patients and controls at baseline as well as over the treatment period.
Children with acquired and congenital brain lesions (namely, cerebral palsy, CP, and acquired brain injury, ABI) may exhibit upper limb impairment, with consequent limitations in their daily living activities. In recent years, robotic rehabilitation has become an important tool to promote functional recovery in patients with CP and ABI, thanks to its ability to promote high intensity, repetitive, engaging training. Moreover, it has additional advantages that can contribute to the understanding of the effectiveness of these devices in motor learning and recovery. It has indeed higher resolution and inter -rater and intra-rater reliability with respect to standard assessment methods (i.e. clinical scales). Furthermore, it is able to provide a quantitative evaluation of patients' movement during treatments instead of relying exclusively on qualitative observation. Recently, Merlo and co-workers (Sol et Salus, Rimini, Italy) developed and validated a tool to extract indices of accuracy, velocity and smoothness from the analysis of 3D trajectories of the end point of the robotic exoskeleton Armeo®Spring (Hocoma, CH). The primary aim of the study is to retrospectively investigate the effectiveness of robot-assisted upper limb rehabilitation in children affected by congenital and acquired brain damages by means of funcional scales and quantitative assessment of movement performance (accuracy, velocity and smoothness). Patients affected by acquired or congenital brain disease are enrolled. The inclusion criteria are: age between 5 and 18; the ability to handle objects in daily life within levels I, II, and III, according to the Manual Ability Classification System (MACS); the ability to understand and follow test instructions. Conversely, the exclusion criteria are: severe muscle contracture and/or spasticity, a diagnosis of severe learning disabilities or behavioral problems and visual or hearing difficulties that would impact on function and participation. Participants undergo the standard intervention protocol followed at the IRCCS E. Medea. It is composed by 20 sessions with Armeo®Spring and 20 sessions of physiotherapy, within 1 month. Patients are evaluated before (T0) and after (T1) the intervention with the Quality of Upper Extremities Skills Test (QUEST) and the Melbourne Assessment of Unilateral Upper Limb Function. During the first, tenth and last training session, patients executed the "Vertical Capture" exergame, which assess patient's functional level during a task that involves elbow flex-extension and shoulder flex- extension and abd-adduction. From these evaluation sessions, quantitative indices of movement performance (precision, velocity and smoothness) are extracted.
The CRS-R is a standardized and validated bedside assessment of conscious awareness. It is used routinely for diagnosis and prognosis of patients with disorders of consciousness (DOC) as well as in research settings. One limitation of the CRS-R is the lengthy administration time required to obtain a total score. Administration time can vary from approximately 15-30 minutes, depending on the patient's level of responsiveness. For this reason, the CRS-R is rarely administered in the acute hospital setting. Less time-consuming scales and metrics are used to assess conscious awareness in the acute hospital/ICU setting, but they lack specificity and sensitivity and have not been validated, increasing the potential for misdiagnosis. In conjunction with the developers of the Neuroscore (an unpublished, abbreviated version of the CRS-R), we have developed the CRSR-FAST and aim to test its validity, inter- and intra- rater reliability. We anticipate that, compared with the CRS-R, the CRSR-FAST will be less time-consuming to administer and score, but will maintain a high level of sensitivity to detecting signs of consciousness in severely brain injured patients.
Traumatic brain injury (TBI) is a condition affecting the persons' central nervous system with a need for extensive and highly specialized initial health care provision followed by comprehensive rehabilitation efforts. Frequent and life-long medical, cognitive, emotional and behavioral changes are expected. The community-based services are largely responsible for dealing with the chronic challenges affecting people with TBI. 120 patients >16 years at the time of injury and between 18 and 72 years at inclusion, with clinical TBI diagnosis on acute admission and verified injury-related intracranial abnormalities reporting cognitive, emotional and physical problems more than 2 years after the injury will be included and randomized to a patient-centered in-home program intervention and treatment as usual. The intervention consists of an individualized and goal-oriented intervention will be provided in the persons' home environment, in close collaboration with family members and local health care providers when available. Assessments will be conducted at baseline, at the end of the intervention 4 months after inclusion and one year after inclusion. Primary outcome is participation (Part-O) and TBI specific health related quality of life (Qolibri). Secondary outcomes include goal attainment within individualized targeted outcome areas, depression and anxiety, symptom burden, unmet health care needs and acceptability of intervention as assessed by patient, family member and health professional. The project will contribute to increased understanding of knowledge transfer processes, and dissemination of evidence based practice for TBI. Thus, the project has the potential to improve the current health care for patients with TBI and its delivery.
The purpose of this research study is to test whether a portable goggle system (I-PAS) is good at diagnosing mild traumatic brain injury (mTBI) in a community setting. The goal is to determine whether the IPAS goggle system can be used reliably in an urgent care or emergency department setting.
OEF/OIF/OND war Veterans have unique post-deployment care needs that the VA is striving to understand and address. Unfortunately, there is a significant disparity in utilization of mental health (MH) care and VA access as most war Veterans don't seek needed care. New interventions are urgently needed to address disparities in post-deployment MH treatment engagement for war Veterans and to support VA's efforts to provide them with optimal access and care. Online health interventions have been shown to be preferred by OEF/OIF combat Veterans and have the potential to promote access to VA MH care. The investigators' research team has developed a web-based interface (WEB-ED) evolved by feedback from Veterans that screens for common post-deployment MH and readjustment concerns, provides tailored education about positive screens, and facilitates linkage to VA resources. Data from the investigators' prior studies demonstrate WEB-ED can be successfully implemented within VA and activate Veterans to seek needed care. Furthermore, emerging evidence indicates that when patients are educated about their health conditions and treatment alternatives using shared decision-making (SDM), increased treatment participation and adherence, and better health outcomes result. Next steps include: linking Veteran WEB-ED screening results to a VA secure network so that a provider can access the results; and integrating a SDM interface to promote Veteran-Provider partnerships in patient-centered care. This study will improve the investigators' understanding of the most effective methods to reduce barriers to enrollment in VA/MHV and transferring important medical information using My HealtheVet (MHV). Furthermore, it will provide important information regarding how WEB-ED results can enhance the capability of VA providers and transition patient advocates to use Veterans' screening results to triage and engage Veterans in patient-centered MH care and promote VA provider adoption of WEB-ED+ to facilitate patient engagement. Online screening, tailored education, and links to geographically accessible VA resources has been shown to be preferred by Veterans, providing recognition of treatable post-deployment MH concerns, and education that reduces stigma. This study builds upon and augments this prior work with research to understand and evaluate the processes needed to integrate WEB-ED+ into current VHA systems to support efficient care delivery, facilitate patient-centered care, and address unmet need for MH care while also resolving disparities in VA and VA MH care access and engagement for war Veterans. WEB-ED+'s use of shared decision making is a key component for promoting these benefits. WEB-ED+ represents a readily implementable and cost-effective intervention that, with partner collaboration, can be integrated into VA systems through MHV. Findings have important policy implications for several operational partners heavily invested in the improved access and delivery of evidence-based mental health care for war Veterans.
Observational longitudinal study assessing outcomes following moderate-severe traumatic brain injury (TBI).
Many patients suffer from a topographical disorientation after a traumatic brain injury. Virtual Reality settings allow us to develop navigational cues, in order to rehabilitate patients or to help them in daily life. Some visual and auditory cues have proved efficient in helping patients navigating in a virtual environment but when administered separately, they never enabled patients to obtain a similar navigation performance as healthy controls. Moreover, the effect of the combination between visual and auditory cues has never been studied before. The objective of the present study is to determine if the combination between visual and auditory cues improve spatial navigation and memory of patients with a traumatic brain injury. Therefore, the investigators intend to include in this prospective randomized study 45 patients who have had a moderate or severe traumatic brain injury and 20 healthy controls. Participants will have to reproduce actively with a joystick three different paths including 6 intersections that they have previously seen on a computer screen. One path will be done without cues, one with visual or auditory cues, and one with combined cues (visual+auditory). The order of the paths will be randomized. Auditory cues consist of beeping sounds indicating the direction at each intersection. Visual cues consist of salient landmarks (red and blinking) positioning at each intersection. The main judgment criterion will be the number of trajectory mistakes during the path reproduction (/6). The secondary judgment criteria will be : time of navigation, memory of the landmarks, the route and the survey of the virtual environment. The confirmation of the help given by the combined cues could further allow the patients to use them in rehabilitation or in real life using augmented reality.