Journal of neurotrauma
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Journal of neurotrauma · Aug 2021
A systematic review of safety reporting in acute spinal cord injury clinical trials: challenges and recommendations.
Accurate safety information in published clinical trials guides the assessment of risk-benefit, as well as the design of future clinical trials. Comprehensive reporting of adverse events, toxicity, and discontinuations from acute spinal cord injury clinical trials is an essential step in this process. Here, we sought to assess the degree of "satisfactoriness" of reporting in past clinical trials in spinal cord injury. ⋯ Discontinuations were satisfactorily reported for the majority of trials (80%), with the remaining partially satisfactory (5%) or unsatisfactory (15%). Reporting of safety in clinical trials for acute spinal cord injury is suboptimal. Due to the complexities of acute spinal cord injury (e.g., polytrauma, multiple systems affected), tailored and specific standards for tracking adverse events and safety reporting should be established.
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Journal of neurotrauma · Aug 2021
Observational StudyNatural Progression of Routine Laboratory Markers following Spinal Trauma: A longitudinal, multi-cohort study.
Our objective was to track and quantify the natural course of serological markers over the 1st year following spinal cord injury. For that purpose, data on serological markers, demographics, and injury characteristics were extracted from medical records of a clinical trial (Sygen) and an ongoing observational cohort study (Murnau study). The primary outcomes were concentration/levels/amount of commonly collected serological markers at multiple time points. ⋯ We conclude that because of trauma-induced physiological perturbations, serological markers undergo marked changes over the course of recovery, from initial pathological levels that normalize within a year. The findings from this study are important, as they provide a benchmark for clinical decision making and prospective clinical trials. All results can be interactively explored on the Haemosurveillance web site (https://jutzelec.shinyapps.io/Haemosurveillance/) and GitHub repository (https://github.com/jutzca/Systemic-effects-of-Spinal-Cord-Injury).
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Journal of neurotrauma · Aug 2021
Efficacy of Early (<=24 hours), Late (25-72 hours), and Delayed (>72 hours) Surgery with MRI-Confirmed Decompression in AIS grades C, D, Acute Traumatic Central Cord Syndrome Due to Spinal Stenosis.
The therapeutic significance of timing of decompression in acute traumatic central cord syndrome (ATCCS) caused by spinal stenosis remains unsettled. We retrospectively examined a homogenous cohort of patients with ATCCS and magnetic resonance imaging (MRI) evidence of post-treatment spinal cord decompression to determine whether timing of decompression played a significant role in American Spinal Injury Association (ASIA) motor score (AMS) 6 months following trauma. We used the t test, analysis of variance, Pearson correlation coefficient, and multiple regression for statistical analysis. ⋯ There was no significant effect of the timing of decompression on follow-up AMS. Only AMS at admission determined AMS at follow-up (coefficient = 0.31; 95% confidence interval [CI]:0.21; p = 0.001). We conclude that timing of decompression in ATCCS caused by spinal stenosis has little bearing on ultimate AMS at follow-up.
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Journal of neurotrauma · Aug 2021
Randomized Controlled TrialA Randomized Controlled Trial of Local Delivery of a Rho-Inhibitor (VX-210) in Patients With Acute Traumatic Cervical Spinal Cord Injury.
Acute traumatic spinal cord injury (SCI) can result in severe, lifelong neurological deficits. After SCI, Rho activation contributes to collapse of axonal growth cones, failure of axonal regeneration, and neuronal loss. This randomized, double-blind, placebo-controlled phase 2b/3 study evaluated the efficacy and safety of Rho inhibitor VX-210 (9 mg) in patients after acute traumatic cervical SCI. ⋯ The pre-defined futility stopping rule was met, and the study was therefore ended prematurely. In the final analysis, the primary efficacy end-point was not met, with no statistically significant difference in change from baseline in upper-extremity motor score at 6 months after treatment between the VX-210 (9-mg) and placebo groups. This work opens the door to further improvements in the design and conduct of clinical trials in acute SCI.
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Journal of neurotrauma · Aug 2021
Comparative StudyCore Temperature Lability Predicts Sympathetic Interruption and Cognitive Performance during Heat Exposure in Persons with Spinal Cord Injuries.
Among persons with high spinal cord injury (Hi-SCI: > T5), changes in core body temperature (Tcore) and cognitive performance during heat exposure appear related to degree of sympathetic interruption. Twenty men with Hi-SCI (C4-T4, American Spinal Injury Association Impairment Scale [AIS] A-B) and 19 matched, able-bodied controls were acclimated to 27°C baseline (BL) before exposure to 35°C heat challenge (HC). Two groups, differentiated by increase in Tcore during HC, were identified: high responders (HR-SCI: ΔTcore ≥0.5°C; n = 13, C4-T2) and low responders (LR-SCI: ΔTcore <0.5°C; n = 7, C4-T4). ⋯ SRavg increased more in the control group (77.0 ± 52.5 nL/cm2/min) than in the HR-SCI group (15.5 ± 22.0 nL/cm2/min; p = 0.001). Only the HR-SCI group had significant increases in T-Scores of Stroop Word (7.5 ± 4.4; p < 0.001), WAIS-IV Digit Span Sequence (1.9 ± 1.8; p = 0.002), and WAIS-IV Digit Span Total (1.4 ± 1.6; p = 0.008). Persons with SCI who responded to HC with a greater change in Tcore demonstrated evidence of greater sympathetic interruption and had an associated improvement in cognitive performance.