Journal of neurotrauma
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Journal of neurotrauma · Nov 2023
Randomized Controlled TrialIntegrating, Harmonizing, and Curating Studies with High-Frequency and Hourly Physiological Data: Proof of Concept from Seven Traumatic Brain Injury Datasets.
Research in severe traumatic brain injury (TBI) has historically been limited by studies with relatively small sample sizes that result in low power to detect small, yet clinically meaningful outcomes. Data sharing and integration from existing sources hold promise to yield larger more robust sample sizes that improve the potential signal and generalizability of important research questions. However, curation and harmonization of data of different types and of disparate provenance is challenging. ⋯ Our harmonized data set included data on 1536 patients from the Citicoline Brain Injury Treatment Trial (COBRIT), Effect of erythropoietin and transfusion threshold on neurological recovery after traumatic brain injury: a randomized clinical trial (EPO Severe TBI), BEST-TRIP, Progesterone for the Treatment of Traumatic Brain Injury III Clinical Trial (ProTECT III), Transforming Research and Clinical Knowledge in Traumatic brain Injury (TRACK-TBI), Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase-II (BOOST-2), and Ben Taub General Hospital (BTGH) Research Database studies. We conclude with process recommendations for data acquisition for future prospective studies to aid integration of these data with existing studies. These recommendations include using common data elements whenever possible, a standardized recording system for labeling and timing of high-frequency physiological data, and secondary use of studies in systems such as Federal Interagency Traumatic Brain Injury Research Informatics System (FITBIR), to engage investigators who collected the original data.
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Journal of neurotrauma · Sep 2023
Randomized Controlled Trial Multicenter StudySafety and Efficacy of Riluzole in Acute Spinal Cord Injury (RISCIS): A Multi-Center, Randomized, Placebo-Controlled, Double-Blinded Trial.
Riluzole is a sodium-glutamate antagonist that attenuates neurodegeneration in amyotrophic lateral sclerosis (ALS). It has shown favorable results in promoting recovery in pre-clinical models of traumatic spinal cord injury (tSCI) and in early phase clinical trials. This study aimed to evaluate the efficacy and safety of riluzole in acute cervical tSCI. ⋯ However, on pre-planned secondary analyses, all subgroups of cervical SCI subjects (AIS grades A, B and C) treated with riluzole showed significant gains in functional recovery. The results of this trial may warrant further investigation to extend these findings. Moreover, guideline development groups may wish to assess the possible clinical relevance of the secondary outcome analyses, in light of the fact that SCI is an uncommon orphan disorder without an accepted neuroprotective treatment.
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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.