Clinical Trials

•Phase II randomized, multicenter, double-blind, multidose, placebo-controlled trial

•160 patients for the safety and efficacy of BIIB093 to inhibit expansion of traumatic cerebral contusion

•Primary endpoint is contusion expansion at 96hrs as determined by MRI

DoD study to recruit 100 SCI pts to compare 8 wks acupuncture to sham.

This trial proposes to compare pain scores for individuals who receive early and regular acupuncture therapy in addition to the usual standard of care after traumatic injury to the spinal cord within the cervical, thoracic or lumbar regions. In addition, we also hope to detect differential results of sensorimotor recovery as measured by the ISNCSCI, although this trial will not be powered to detect these differences. We will enroll 100 subjects with cervical, thoracic or lumbar SCI with AIS scores ranging from A-D over a 36-month period from the Neurotrauma Center within the R Adams Cowley Shock Trauma Center (STC) at the University of Maryland Medical Center. Our aim is to compare treatment outcomes for those subjects that receive acupuncture treatment in addition to the normal standard of care, to a control group that will only receive the normal standard of care with the objective of determining if there is any additional benefit to providing early acupuncture intervention for this patient population in the hospital setting.

People who experience traumatic brain injury (TBI) are at risk for developing life-threatening complications such as organ dysfunction and a major infection called sepsis. Identifying patients who are at risk for these complications may help clinicians prevent and treat them. The purpose

of this study is to compare the genes, intestinal bacteria, and how well bloods cells make energy between TBI patients who get organ dysfunction or sepsis and those who do not.

Participants in this study will have blood and stool (poop) samples collected on admission (day 0), and again at days 1, 2, 4, and 7 of their hospital stay. Stool will be collected only once a day for days 0, 1, 2, 4(anywhere from day 3-5), and 7 (anywhere from day 6-8). Stool collected from admission (day 0) will be collected on a special “Q-tip” which will touch the outside of the

glove used during a rectal exam as part of admission or the stool directly if the participant defecates on his/her own. On days 1, 2, 4, and 7, stool is collected only when the study participant goes to the bathroom on their own (or has a bowel movement). Either way, a stool sample will only be collected once the stool is outside of the body. If the study participant does not have a rectal exam nor poops on their own, then a stool sample will not be collected that day. Blood will be collected once on day 0 using leftover blood from admission labs. Blood will be collected once a day on days 1, 2, 4, and 7, but only as part of the routine clinical blood draw. The comparisons of the genes, intestinal bacteria and how well bloods cells make energy will be done in a laboratory after collection of the samples. Your participation in the study will be complete after 8 days, once the final blood and stool samples have been collected. We will collect information from the medical record for the entire hospitalization up to a maximum of 30 days.

There continues to be an overarching problem of high mortality and poor outcome for victims of severe traumatic brain injury (TBI). Preclinical and clinical investigations indicate that hyperbaric oxygen (HBO) has a positive impact on reducing brain injury and improving outcomes in severe TBI. By markedly increasing oxygen (O2) delivery to the traumatized brain, HBO can reverse the lack of O2 that precipitates cellular energy failure and subsequent brain cell death. However, prior to a formal phase III definitive efficacy study, important information is required regarding optimizing the HBO treatment schedule to be instituted in terms of pressure, frequency and other parameters. The lungs in severe TBI subjects have frequently been compromised by direct lung injury and/or acquired ventilator pneumonia and are susceptible to O2 toxicity. It is essential to determine the most effective HBO dose schedule without producing O2 toxicity and clinical complications. This proposed adaptive clinical trial is designed to answer these questions and to provide important data to plan a definitive phase III efficacy trial.

Objective 1: (Signal of efficacy) To determine, in subjects with severe TBI, whether there is a >50% probability of hyperoxia treatment demonstrating improvement in the rate of good neurological outcome versus control in a subsequent confirmatory trial. Objective 2: (Dose selection) To select, in subjects with severe TBI, the combination of treatment parameters (pressure +/- intervening normobaric hyperoxia [NBH]) that is most likely to demonstrate improvement in the rate of good neurological outcome versus control in a subsequent confirmatory trial.

Primary Endpoint: To assess efficacy, the treatment groups will be compared with respect to the proportion of subjects with favorable outcome at 6 months post-randomization. Favorable outcome is defined based on the sliding dichotomy methodology whereby subjects with the most severe injury and whose initial Glasgow Coma Scale (GCS) scores are 3-5 are considered to have a favorable outcome if their 6-month Glasgow Outcome Scale – Extended (GOS-E) score is upper good recovery to upper severe disability; subjects with less severe injury and whose initial GCS scores are 6-8 are considered to have a favorable outcome if their 6-month GOS-E score is upper good recovery to lower moderate disability.

NIH multicenter comparative effectiveness study to test the efficacy of a prescribed treatment protocol based on monitoring the partial pressure of brain tissue oxygen PbtO2 (ie, ICP vs ICP +PbtO2).

Objective: BOOST3 is a comparative effectiveness study to test the efficacy of a prescribed treatment protocol based on monitoring the partial pressure of brain tissue oxygen PbtO​2​.

Primary Objective: To determine whether the prescribed treatment protocol, informed by PbtO​2 monitoring, results in improved neurologic outcome measured by the Glasgow Outcome Scale-Extended (GOS-E) 6 months after injury compared to treatment based on intracranial pressure (ICP) monitoring only.

7 Center DoD safety and efficacy cross-over trial to recruit 120 pts/4yrs comparing 48 hr 33C to SoC. C4-C8. ASIA A-C.