Journal of neurotrauma
-
Journal of neurotrauma · Sep 2019
Randomized Controlled Trial Multicenter StudyCost-effectiveness of Erythropoietin in Traumatic Brain Injury (EPO-TBI): A multinational trial based economic analysis.
The EPO-TBI multi-national randomized controlled trial found that erythropoietin (EPO), when compared to placebo, did not affect 6-month neurological outcome, but reduced illness severity-adjusted mortality in patients with traumatic brain injury (TBI), making the cost-effectiveness of EPO in TBI uncertain. The current study uses patient-level data from the EPO-TBI trial to evaluate the cost-effectiveness of EPO in patients with moderate or severe TBI from the healthcare payers' perspective. We addressed the issue of transferability in multi-national trials by estimating costs and effects for specific geographical regions of the study (Australia/New Zealand, Europe, and Saudi Arabia). ⋯ Mean unadjusted costs (95% CI) were $US5668 (-9191 to -2144; p = 0.002) lower in the treatment group; controlling for baseline IMPACT-TBI score and regional heterogeneity reduced this difference to $2377 (-12,446 to 7693; p = 0.64). For a willingness-to-pay threshold of $US50,000 per QALY, 71.8% of replications were considered cost-effective. Therefore, we did not find evidence that EPO was significantly cost-effective in the treatment of moderate or severe TBI at 6-month follow-up.
-
Journal of neurotrauma · Sep 2019
Randomized Controlled TrialGlasgow Outcome Scale Measures and Impact on Analysis and Results of a Randomized Clinical Trial of Severe TBI.
The original unstructured Glasgow Outcome Scale (uGOS) and the newer structured interviews GOS and the Extended GOS (GOS-E) have been used widely as outcomes in severe traumatic brain injury (TBI) trials. We compared outcome categories (ranging from dead [D] to good recovery [GR]) for each measure in a randomized trial of transfusion threshold and the implications of measure choice and analysis methods for the results of the trial. We planned to explore patient symptomology possibly driving any discrepancies between the patient's uGOS and GOS scores. ⋯ An effect was not detected using ordinal logistic regression or sliding dichotomy method for all three measures. Differences in categorizations of subjects between moderate and severe disability among the scales impacted conclusions of the trial. In future studies, particular attention should be given to implementing GOS measures and describing the methodology for how outcomes were ascertained.
-
Journal of neurotrauma · Jul 2019
Randomized Controlled TrialA Pilot Investigation of Repetitive Transcranial Magnetic Stimulation for Post-Traumatic Brain Injury Depression: Safety, Tolerability, and Efficacy.
Depression following a traumatic brain injury (TBI) is common and difficult to treat using standard approaches. The current study investigated, for the first time, transcranial magnetic stimulation (TMS) for the treatment of post TBI depression. We specifically assessed the safety, tolerability, and efficacy of TMS in this patient population. ⋯ There were significant improvements in cognition following active rTMS in the areas of working memory (p = 0.021) and executive function (p = 0.029). rTMS was shown to be safe and well tolerated in patients who had developed depression after a TBI. We did not find a therapeutic effect for post-TBI depression; however, this approach may have some utility in improving cognitive function. Future research should focus on alternative rTMS treatment approaches for post-TBI depression and the direct investigation of rTMS as a treatment for cognitive impairment in TBI.
-
Journal of neurotrauma · Jun 2019
Randomized Controlled Trial Comparative StudyKinematic and Neuromuscular Adaptations in Incomplete Spinal Cord Injury after High- versus Low-Intensity Locomotor Training.
Recent data demonstrate improved locomotion with high-intensity locomotor training (LT) in individuals with incomplete spinal cord injury (iSCI), although concerns remain regarding reinforcement of abnormal motor strategies. The present study evaluated the effects of LT intensity on kinematic and neuromuscular coordination in individuals with iSCI. Using a randomized, crossover design, participants with iSCI received up to 20 sessions of high-intensity LT, with attempts to achieve 70-85% of age-predicted maximum heart rate (HRmax), or low-intensity LT (50-65% HRmax), following which the other intervention was performed. ⋯ These findings suggest greater neuromuscular complexity may be due to LT and not necessarily differences in speeds. Only selected kinematic changes (i.e., weak hip excursion) was correlated to improvements in treadmill speed. In conclusion, LT intensity can facilitate gains in kinematic variables and neuromuscular synergies in individuals with iSCI.
-
Journal of neurotrauma · May 2019
Randomized Controlled TrialSelf-Assisted Standing Enabled by Non-Invasive Spinal Stimulation after Spinal Cord Injury.
Neuromodulation of spinal networks can improve motor control after spinal cord injury (SCI). The objectives of this study were to (1) determine whether individuals with chronic paralysis can stand with the aid of non-invasive electrical spinal stimulation with their knees and hips extended without trainer assistance, and (2) investigate whether postural control can be further improved following repeated sessions of stand training. Using a double-blind, balanced, within-subject cross-over, and sham-controlled study design, 15 individuals with SCI of various severity received transcutaneous electrical spinal stimulation to regain self-assisted standing. ⋯ Quality of balance control was practice-dependent, and improved with subsequent training. During self-initiated body-weight displacements in standing enabled by spinal stimulation, high levels of leg muscle activity emerged, and depended on the amount of muscle loading. Our findings indicate that the lumbosacral spinal networks can be modulated transcutaneously using electrical spinal stimulation to facilitate self-assisted standing after chronic motor and sensory complete paralysis.