Journal of neurotrauma
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Journal of neurotrauma · Nov 2021
Randomized Controlled Trial Multicenter StudyExercise improves cardiorespiratory fitness but not arterial health after spinal cord injury: The CHOICES trial.
Arterial stiffness, as measured by carotid-femoral pulse wave velocity (cfPWV), is elevated after spinal cord injury (SCI). In the uninjured population, exercise training has been shown to reduce arterial stiffness. In a randomized, multi-center clinical trial, we evaluated the impact of two exercise interventions on cardiovascular disease risk factors in persons with chronic SCI. ⋯ However, peak oxygen uptake increased with ACET compared with BWSTT (p = 0.04). The findings of this trial demonstrate that although 24 weeks of upper-body exercise improved CRF in persons with motor-complete SCI ≥T6, neither intervention resulted in improvements in arterial stiffness or cardiometabolic health measures. ClinicalTrials.gov identifier: NCT01718977.
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Journal of neurotrauma · Oct 2021
Randomized Controlled Trial Multicenter StudyTargeting Autoregulation-Guided Cerebral Perfusion Pressure after Traumatic Brain Injury (COGiTATE): A Feasibility Randomized Controlled Clinical Trial.
Managing traumatic brain injury (TBI) patients with a cerebral perfusion pressure (CPP) near to the cerebral autoregulation (CA)-guided "optimal" CPP (CPPopt) value is associated with improved outcome and might be useful to individualize care, but has never been prospectively evaluated. This study evaluated the feasibility and safety of CA-guided CPP management in TBI patients requiring intracranial pressure monitoring and therapy (TBIicp patients). The CPPopt Guided Therapy: Assessment of Target Effectiveness (COGiTATE) parallel two-arm feasibility trial took place in four tertiary centers. ⋯ There were no significant differences between groups for TIL or for other safety end-points. Conclusively, targeting an individual and dynamic CA-guided CPP is feasible and safe in TBIicp patients. This encourages a prospective trial powered for clinical outcomes.
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Journal of neurotrauma · Aug 2021
Randomized Controlled TrialCarbamazepine for Irritability and Aggression after Traumatic Brain Injury: A Randomized, Placebo-Controlled Study.
This study tested the hypothesis that carbamazepine (CBZ) reduces irritability/aggression among individuals >6 months post-traumatic brain injury (TBI). Seventy individuals were enrolled in a parallel-group, randomized, double-blind, placebo-controlled, forced-titration trial of CBZ (n = 35) versus placebo (n = 35). Participants were randomly assigned to receive CBZ or placebo 42 days with outcome assessed at baseline and Day 42. ⋯ Large placebo effects may have masked the detection of differences. Clinician rating metrics suggest benefit, and thus, CBZ should remain a treatment option for the experienced brain injury clinician. Data are provided that may aid treatment decisions.
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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 · Jul 2021
Randomized Controlled Trial Multicenter StudyProgesterone treatment does not decrease serum levels of biomarkers of glial and neuronal cell injury in moderate and severe TBI subjects: A secondary analysis of the Progesterone for Traumatic Brain Injury, Experimental Clinical Treatment (ProTECT) III trial.
Early treatment of moderate/severe traumatic brain injury (TBI) with progesterone does not improve clinical outcomes. This is in contrast with findings from pre-clinical studies of progesterone in TBI. To understand the reasons for the negative clinical trial, we investigated whether progesterone treatment has the desired biological effect of decreasing brain cell death. ⋯ There was no statistically significant correlation between serum progesterone concentrations and biomarker values obtained at 24 and 48 h. When examined as a continuous variable, baseline biomarker levels did not modify the association between progesterone treatment and neurological outcome (p of interaction term >0.39 for all biomarkers). We conclude that progesterone treatment does not decrease levels of biomarkers of glial and neuronal cell death during the first 48 h post-injury.