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
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).
Systemic hypothermia in acute spinal cord injury
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.