
Serum Neurofilament Light (NfL) as a Marker for Brain Injury in Individuals Undergoing Chimeric...
NeurotoxicityThe investigators propose that immune effector cell-associated neurotoxicity syndrome (ICANS) is predicated upon the early loss of blood brain barrier (BBB) integrity with subsequent monocyte infiltration leading to cross-activation of native glial cells. Glial overstimulation leads to neuroinflammation, synaptic dysfunction, and ultimately neuronal injury.

Safe@Home: A Self-Management Program for Individuals With TBI and Their Families
Brain InjuriesTraumaticPeople who sustain moderate to severe traumatic brain injury (TBI) have an increased risk for unintentional injury and harm when resuming day to day activities in the home and community. People who sustain brain injuries primarily want to independently do the activities they enjoy while families primarily focus on avoiding injury or other harm events. Safe@Home is an injury prevention education and activity training program. Participants who have sustained a moderate or severe TBI receive a personalized strengths and safety risk assessment, tailored injury prevention education, and in-home training with a transition coach on self-selected activities. This study will evaluate whether the Safe@Home program reduces injuries and harm and increases clients' independence in their everyday activities in the home and community compared to a usual care control group.

IL-1ra Dose-range Study for Moderate-to-severe TBI Patients
Traumatic Brain INjuryTraumatic brain injury (TBI) is a common condition with high degree of morbidity and mortality (Hyder et al., 2007). Current treatment paradigms for TBI focus on mitigating secondary injury and maintaining cerebral physiology (Carney et al., 2016), however, there are currently no approved drugs that target the underlying conditions for patients suffering from TBI (Bullock et al., 1999). It is increasingly recognised that the innate inflammatory response to TBI may inflict injury (Lucas et al., 2006), and one of the most prominent mediators of inflammation in the injured brain is the Interleukin-1 (IL-1) receptor pathway (Allan et al., 2005). An endogenous antagonist to IL-1, is available in recombinant form (IL-1ra, Kineret), and is known to be safe in TBI (Helmy et al., 2014). In order to fully understand, and potentially optimize, the effect of Kineret, the investigators wish to conduct a dose-response study by giving three cohorts (n=20 per group) either placebo (isotonic saline), 1.5g or 3.0g of active substance administered intravenously in a double-blind, randomized setting. The concentrations have in previous studies not been shown to present any side-effects (Singh et al., 2014). The drug will be provided within 12 hours after trauma. The goal will be to provide a dose-response effect on the cerebral inflammatory response. As secondary goals, the investigators will assess the brain damage by measuring proteins in blood and cerebrospinal fluid, functional outcome and inflammation in the brain using positron emission tomography.

Derivatives of Omega-3 HUFA as Biomarkers of Traumatic Brain Injury
TBIThis is a Phase 2 clinical trial designed to obtain data on relationships between potentially therapeutic doses of n-3 HUFA (highly unsaturated fatty acids) and their bioactive molecular derivatives, synaptamide, 17-hydroxy-DHA, and D-series resolvins, on clinical outcomes after TBI.

Study to Improve Outcomes for Survivors of Traumatic Brain Injury in Latin America
Traumatic Brain InjuryBrain InjuriesPeople who survive severe traumatic brain injury (TBI) live with profound cognitive impairments that alter their developmental course and define their future possibilities. Worldwide, TBI is the leading cause of death and disability among children and adolescents (Murgio, 2000). In the United States, the annual incidence of TBI is six times greater than that of multiple sclerosis, HIV/AIDS, spinal cord injury, and breast cancer combined [Centers for Disease Control, American Cancer Society, National Multiple Sclerosis Society]. The burden of TBI may be even greater in developing countries, due to civil unrest and war, and to the absence of mandated prevention such as seat belt laws. The long-term objective of the investigators' research group is to improve outcomes for survivors of TBI in Latin America. To that end, the investigators have created a structure for professionals and institutions involved in the treatment of TBI to generate research; to facilitate education, standardization, certification, the dissemination of information and resources; and to foster the development of evidence-based guidelines. The structure is the Latin American Brain Injury Consortium (LABIC).

Effect of Rozerem on Sleep Among People With Traumatic Brain Injury
InsomniaBrain InjuryThis pilot study proposes to examine the effect of Rozerem on sleep/wake patterns among individuals with Traumatic Brain Injury (TBI) experiencing sleep disturbance, using both objective and subjective measures. It will also show that improvement in sleep/wake patterns resulting from Rozerem will impact daytime functioning using objective and subjective measures.

Transcranial Magnetic Stimulation (TMS) for Suicidal Ideation
Depressive EpisodePosttraumatic Stress Disorder1 moreThe purpose of this study is to determine whether transcranial magnetic stimulation (TMS) is effective in the treatment of suicidal thinking in individuals with a depressive episode and either posttraumatic stress disorder (PTSD), history of mild traumatic brain injury (TBI), or both conditions.

Hyperbaric Oxygen Therapy in Chronic Traumatic Brain Injury or Post-Traumatic Stress Disorder
Traumatic Brain InjuryPost-traumatic Stress DisorderThis is an observational research study whose purposes are to see: if 40 Hyperbaric Oxygen Therapy sessions at 1.5 atmospheres (HBOT 1.5) or more (60, or 80 HBOT's) help, worsen, or have no effect on subjects with chronic TBI/PCS (Traumatic Brain Injury/Post-Concussion Syndrome) and/or PTSD (Post-Traumatic Stress Disorder). if improvements or worsening of symptoms can be recorded with computerized and written tests for memory and thinking, and with questionnaires about the subject's quality of life and health. determine the long-term outcome of the treatment. confirm, in large numbers of study participants at multiple sites nationwide, the strong positive results obtained in pilot studies

Investigating the Role of the Premotor Cortex in Higher Cognitive Functions
Brain InjuryChronicThis project aims at understanding better the role of the frontal lobe of the brain in our capacity to perceive visual information consciously, and also, in our capacity to perceive others' actions. It includes a test where we ask subjects to detect visual information in front of a computer screen, and another test where we ask them to imitate finger movements.

Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Brain Injury.
Craniocerebral TraumaTraumatic Brain Injury2 moreThe aim of this study is to determine effect of proprioceptive stimulation with passive gait training on the cortical activity in patients with severe brain injury, demonstrated as changes in EEG (electroencephalogram)and ERP (Event Related Potentials). Hypotheses: 1) Proprioceptive stimulation increases EEG-frequency in patients with impaired consciousness due to severe brain injury. 2) Proprioceptive stimulation increases conductivity speed of the cognitive P300-component of ERP in patients with impaired consciousness due to severe brain injury.