Articles: brain-injuries.
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Brain injury : [BI] · Jan 2015
Randomized Controlled TrialSubjective sleep quality and postconcussion symptoms following mild traumatic brain injury.
The goal of this investigation is to examine the prevalence of poor subjective sleep in patients with a history of mild traumatic brain injury (mTBI) and examine the relationship between subjective sleep quality and postconcussive symptoms (PCS), above and beyond the typical demographic and psychological distress variables. ⋯ Results indicate that poor subjective sleep quality is a significant problem in those with mTBI. While sleep is associated with PCS severity, psychological distress is a more potent predictor.
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Randomized Controlled Trial Multicenter Study
A clinical trial of progesterone for severe traumatic brain injury.
Progesterone has been associated with robust positive effects in animal models of traumatic brain injury (TBI) and with clinical benefits in two phase 2 randomized, controlled trials. We investigated the efficacy and safety of progesterone in a large, prospective, phase 3 randomized clinical trial. ⋯ Primary and secondary efficacy analyses showed no clinical benefit of progesterone in patients with severe TBI. These data stand in contrast to the robust preclinical data and results of early single-center trials that provided the impetus to initiate phase 3 trials. (Funded by BHR Pharma; SYNAPSE ClinicalTrials.gov number, NCT01143064.).
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Randomized Controlled Trial Multicenter Study
Very early administration of progesterone for acute traumatic brain injury.
Traumatic brain injury (TBI) is a major cause of death and disability worldwide. Progesterone has been shown to improve neurologic outcome in multiple experimental models and two early-phase trials involving patients with TBI. ⋯ This clinical trial did not show a benefit of progesterone over placebo in the improvement of outcomes in patients with acute TBI. (Funded by the National Institute of Neurological Disorders and Stroke and others; PROTECT III ClinicalTrials.gov number, NCT00822900.).
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Randomized Controlled Trial Multicenter Study
Statistical analysis plan for the Erythropoietin in Traumatic Brain Injury trial: a randomised controlled trial of erythropoietin versus placebo in moderate and severe traumatic brain injury.
The Erythropoietin in Traumatic Brain Injury (EPO-TBI) trial aims to determine whether the administration of erythropoietin to patients with moderate or severe traumatic brain injury improves patient-centred outcomes. ⋯ A detailed analysis plan has been developed for EPO-TBI that is consistent with international guidelines. This plan specifies the statistical models for evaluation of primary and secondary outcomes, as well as defining covariates for adjusted analyses. Application of this statistical analysis plan to the forthcoming EPO-TBI trial will facilitate unbiased analyses of these important clinical data.
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Randomized Controlled Trial
Armodafinil for the treatment of excessive sleepiness associated with mild or moderate closed traumatic brain injury: a 12-week, randomized, double-blind study followed by a 12-month open-label extension.
To evaluate the efficacy and tolerability of armodafinil in patients with excessive sleepiness following mild or moderate closed traumatic brain injury (TBI). ⋯ Armodafinil 250 mg significantly improved sleep latency in patients with excessive sleepiness associated with mild or moderate TBI. Efficacy and tolerability of armodafinil were sustained throughout the open-label extension.