Journal of neurotrauma
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Journal of neurotrauma · Sep 2023
Randomized Controlled TrialThe RISCIS-PK substudy: An analysis of pharmacokinetics, pharmacodynamics, and impact on axonal degradation of riluzole in patients with traumatic cervical spinal cord injury enrolled in the RISCIS Phase III Randomized Controlled Trial.
To date, no drug therapy has shown significant efficacy in improving functional outcomes in patients with acute spinal cord injury (SCI). Riluzole is an approved benzothiazole sodium channel blocker to attenuate neurodegeneration in amyotrophic lateral sclerosis (ALS) and is of interest for neuroprotection in SCI. In a Phase I clinical trial (ClinicalTrials.gov Identifier: NCT00876889), riluzole was well tolerated with a 2-week treatment at the dose level approved for ALS and exhibited potential efficacy in patients with SCI. ⋯ The development of effective treatment for SCI is challenging. However, the future model-informed and PK-guided drug development and regimen modification can be rationally executed with the optimal dosing regimen design based on the developed 3D PK/PD model. The PK/PD/CO model can serve as a rational guide for future drug development, PKPD model refinement, and extension to other studies in SCI settings.
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Journal of neurotrauma · Aug 2023
Randomized Controlled TrialRandomized evaluation of CDC HEADS UP concussion education materials for youth sport coaches.
The Centers for Disease Control and Prevention (CDC) HEADS UP youth sports coach materials are the most widely adopted form of concussion education for coaches across the United States-reaching millions of youth sports coaches over the last decade. These materials focus on concussion symptom identification, response, and management (e.g., return to school and sports), while also addressing the importance of communicating to athletes and their families about concussion safety. The purpose of this study was to assess the effectiveness of CDC HEADS UP materials on coach knowledge and communication with youth athletes about concussion safety. ⋯ Concussion symptom knowledge and communication intentions also significantly increased in the intervention group but not in the control group. This study provides evidence that CDC HEADS UP materials increase the likelihood that youth sport coaches communicate with their athletes about concussion safety. As youth sports organizations increasingly mandate concussion education for coaches, CDC HEADS UP materials may be considered a leading resource for adoption and setting-relevant implementation.
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Journal of neurotrauma · Feb 2023
Randomized Controlled TrialChange in hematoma size after dexamethasone therapy in chronic subdural hematoma subtypes: A prospective study in symptomatic patients.
The main treatment strategy for chronic subdural hematoma is surgical intervention. When a conservative pharmacological approach is considered in symptomatic patients, mainly dexamethasone therapy is applied. Recent trials revealed dexamethasone therapy to be an ineffective treatment in symptomatic patients with chronic subdural hematoma. ⋯ Additional surgery was performed in 57% of patients with the highest observed rate (81%) in separated hematoma. Largest hematoma reduction and better clinical improvement was observed in chronic subdural hematoma without hyperdense components after dexamethasone therapy. Evaluation of these parameters can be part of an individualized treatment strategy.
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Journal of neurotrauma · Jan 2023
Randomized Controlled TrialMilnacipran ameliorates executive function impairments following frontal lobe traumatic brain injury in male rats: a multimodal behavioral assessment.
Traumatic brain injuries (TBIs) affect more than 10 million patients annually worldwide, causing long-term cognitive and psychosocial impairments. Frontal lobe TBIs commonly impair executive function, but laboratory models typically focus primarily on spatial learning and declarative memory. We implemented a multi-modal approach for clinically relevant cognitive-behavioral assessments of frontal lobe function in rats with TBI and assessed treatment benefits of the serotonin-norepinephrine reuptake inhibitor, milnacipran (MLN). ⋯ Both AST tests revealed significant deficits in TBI+VEH rats, seen as elevated total trials and errors (p < 0.05), which generally normalized in MLN-treated rats (p < 0.05). This first simultaneous dual AST assessment demonstrates oAST and dAST are sufficiently sensitive and robust to detect subtle attentional and cognitive flexibility executive impairments after frontal lobe TBI in rats. Chronic MLN administration shows promise for attenuation of post-TBI executive function deficits, thus meriting further investigation.
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Journal of neurotrauma · Jan 2023
Randomized Controlled TrialUse of olanzapine to treat agitation in traumatic brain injury: a series of n-of-one trials.
Agitation is common during post-traumatic amnesia (PTA) following traumatic brain injury (TBI) and is associated with risk of harm to patients and caregivers. Antipsychotics are frequently used to manage agitation in early TBI recovery despite limited evidence to support their efficacy, safety, and impact upon patient outcomes. The sedating and cognitive side effects of these agents are theorized to exacerbate confusion during PTA, leading to prolonged PTA duration and increased agitation. ⋯ Importantly, administration of olanzapine during PTA may lead to increased patient confusion, possibly prolonging PTA. When utilizing olanzapine, physicians must therefore balance the possible advantages of agitation management with the possibility that the patient may never respond to the medication and may experience increased confusion, longer PTA and potentially poorer outcomes. Further high-quality research is required to support these findings and the efficacy and outcomes associated with the use of any pharmacological agent for the management of agitation during the PTA period.