View clinical trials related to Brain Injuries.
Filter by:The primary outcome of this study was to identify mortality predictors/risk factors affecting mortality and secondary outcome was to determine the distribution of brain injury types and other parameters according to type of trauma in patients with TBI treated in anesthesia-reanimation tertiary ICU.
Building a Large Chinese Cohort(Chinese Severe brain injury Trial）
There is a paucity of knowledge about mechanisms behind mild traumatic brain injury (mTBI) subgroup's sustained problems, and effective interventions that can alleviate this disabling condition. Persistent Post-concussive Symptoms (PCS) affect between 20% and 30% of individuals after mTBI. This Randomized Controlled Trial (RCT) will investigate whether graded aerobic exercise has a positive effect on symptom burden (including exercise intolerance) and Autonomic Nervous System (ANS) dysfunction in patients with PCS. This study will expand upon previous work on adolescents with sport-related concussion in the acute phase. It will cover a wider age group and will include patients with persisting symptoms, thus providing knowledge on whether a sub-symptom threshold aerobic exercise program will alleviate symptom burden in adult patients with PCS. Furthermore - looking into the relationship between mTBI and ANS function, this study is expected to contribute to a better understanding of the neurobiological factors involved in PCS. The results may also help developing targeted interventions to specific characteristics in persistent symptoms after mTBI.
Cognitive sequelae are common following acquired brain injuries. However, their detection can be challenging, particularly in acute care units such as neurosurgery. Specific screening in acute phase is critical for early detection and proper orientation. The Lariboisière cognitive assessment (Cog-First) is a brief cognitive evaluation conducted on a touch-screen tablet for patients with acquired brain injuries in the acute phase, which is integrated into routine care in Lariboisière. The objective of this project is to evaluate the one-year cognitive and functional outcomes of patients who have undergone hospitalization in neuro-surgery. The primary aim is to assess whether the systematic pre-discharge assessment (Cog-First) performed as part of routine care can predict a poor functional prognosis and help identify at-risk patients earlier and more effectively.
The goal of this clinical trial is to analyze the usability and safety of the robotic gait device EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy. Participants will use the exoskeletons in their home and the community and variables regarding safety and usability will be measured and recorded.
After severe acquired brain injury (SABI: severe traumatic brain injury, stroke, anoxic brain damage), up to 50-70% of patients are tracheostomized. The need to tracheostomize a patient is based on the prolonged inability to breathe and/or protect their airway sufficiently. This is usually done in an Intensive Care Unit (ICU). A tracheostomy is first removed when the patient's clinical conditions allow for it. The removal can be performed in many settings, a neurological rehabilitation unit being one of these. The overall objective of this study is to evaluate the safety of this earlier decannulation procedure in patients with SABI at our department as well as the effectiveness on functional ability.
Traumatic Brain Injury (TBI) is an alteration of brain function caused by an external force. Long-term mortality in TBI is substantial, TBI survivors can develop chronic progressive disabilities and have a life expectancy shortened by 6 years. Treatment consists in supportive therapy directed at prevention of second insults, but no neuroprotective therapy is available. Given the multifaceted nature of TBI, mesenchymal stromal cells (MSCs) are an ideal candidate: they release multiple soluble factors shown to ameliorate the injury microenvironment through immunomodulatory, protective, reparative and regenerative processes. Preclinical data across a range of different TBI models and injury severities show that human MSCs improve outcome through pleiotropic mechanisms of protection and repair. Thus, data indicate MSCs as strong therapeutic candidate and support a clinical study in TBI. Aim: the study is designed to assess the safety and the efficacy of the MSCs, intravenously administered in severe TBI patients within 48h from injury. The study will be conducted in a stepwise manner. Step 1 will enroll 36 patients (randomized 1:1:1 in arms 80 x 10^6 MSCs vs 160 x 10^6 MSCs vs placebo) to define safety, and will allow to select the most promising dose. Step 2 will enroll 30 patients (1:1 in arms MSCs selected dose vs placebo) to define the MSC activity based on the quantification of the plasmatic levels of the neurofilament light (NFL) at 14 days, as biomarker of neuronal damage. Secondary objectives are aimed to assess: 1. brain injury evolution and white matter damage by longitudinal neuroimaging (at 4 days and 14 days post-TBI and at 6 months) 2. brain immunomodulatory changes by temporal profiling of circulating biomarkers of brain damage and neuroinflammation (daily for 3 days after TBI, at day 7 and 14, and at 1, 6 and 12 months) 3. clinical outcome by a structured clinical and neuropsychological assessment at both 6 and 12 months Methods: a multicenter, double blind, randomized, placebo-controlled, adaptive phase II dose finding study. Duration of the study: 36 months (24 of enrolment and 12 of follow up). Funding: Fondazione Regionale per la ricerca Biomedica, FRRB (Call "Unmet medical needs", proposal number 3440227) and Italian Ministry of health (Ministero della Salute, Bando di Ricerca Finalizzata 2021; proposal number RF-2021-12372642).
Acquired brain injury (ABI) is the leading cause of death and disability worldwide. The degree of severity varies according to a combination of numerous demographics, etiological, clinical, cognitive, behavioral, psychosocial and environmental factors, which can interfere with the effectiveness of rehabilitation interventions and, therefore, with the final outcome. The most important goal of the modern clinic is to predict in time the progression of possible recovery after the brain injury event in order to provide more effective treatment, but the high heterogeneity and clinical variability and the unpredictability of the onset of comorbidities makes this a hard target to reach. In recent years, artificial intelligence algorithms have been applied to more precisely define the role of critical variables that can help clinical practice to predict the final outcome. The classical approach of these algorithms provides only probabilistic values on the final outcome, without considering the typology of clinical interventions and overall complications that may appear throughout the hospitalization period. The objective of this multicentric study is to define a new statistical approach that can describe the dynamics of individual clinical changes occuring during the inpatient intensive rehabilitation care period. The proposed approach combines a principal component analysis (PCA) for dimension reduction (capturing the maximum amount of information and reducing the dimensionality problem) and a nonlinear mathematical modeling for describing the evolution of the clinical course in terms of the resulting new PCA dimensions. By using this approach, we may determine the individual patient's temporal trajectories while examining particular clinical factors. The secondary objective of this study is to validate a new version of the Early Rehabilitation Barthel Index (ERBI), a well-known clinical scale used to measure functional changes in patients with severe acquired brain injury.
One in 60 children have a physical disability that can impact activities and participation. Occupational and physical therapies can be of great benefit, but are costly and difficult to access. Working with children, parents and clinicians, the investigators developed a mixed reality video game, Bootle Blast, which children can play to develop motor skills. Using a 3D sensor, Bootle Blast tracks movements and manipulation of real-life objects. Since 2017, Bootle Blast has been used in clinics by Holland Bloorview, Canada's largest children's rehabilitation hospital. Home use of Bootle Blast has resulted in positive clinical outcomes for children with cerebral palsy. Bootle Blast is not yet commercially available and has yet to be trialed in "real-world" contexts. To understand real-world implementation, Bootle Blast will be trialed for 14 weeks in the homes of 60 young people (6 to 17 years) with any motor condition that could be addressed by the Bootle Blast system, regardless of their diagnosis. The investigators will assess feasibility (e.g. independent home setup, ability to set/meet self-directed play time goals), enablers/barriers to use, and perceived value. User experience will inform product, training and resource development. The research team combines expertise in engineering design, medicine, physiotherapy, qualitative methods, commercialization, knowledge translation, and includes young people with lived experience.
Music therapy has received more attention with its surging application in neuro-rehabilitation overseas. Given the dearth of music therapy and cognitive rehabilitation research conducted in Malaysia, this pilot study intended to investigate the effect of active and passive music therapy interventions versus the standard care condition in cognition among adults with neuro-rehabilitation needs.