Journal of neurotrauma
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Journal of neurotrauma · Apr 2024
Randomized Controlled TrialComparative efficacy of high-intensity training vs conventional training in individuals with chronic traumatic brain injury: a pilot randomized controlled study.
Numerous studies have evaluated the efficacy of interventions to improve locomotion after acute-onset brain injury, although most focus on patients with stroke, with less attention toward traumatic brain injury (TBI). For example, a number of studies in patients post-stroke have evaluated the effects of high-intensity training (HIT) attempting to maximize stepping practice, while no studies have attempted this intervention in patients with TBI. The purpose of this blinded-assessor randomized trial was to evaluate the effects of HIT focused on stepping practice versus conventional training on walking and secondary outcomes in individuals with TBI. ⋯ Greater gains were also observed in estimates of aerobic capacity and efficiency after HIT, with additional improvements in selected cognitive assessments. The present study suggests that the amount and intensity of stepping practice may be important determinants of improved locomotor outcomes in patients with chronic TBI, with possible secondary benefits on aerobic capacity/efficiency and cognition. Clinical Trial Registration-URL: https://clinicaltrials.gov/; Unique Identifier: NCT04503473.
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Journal of neurotrauma · Mar 2024
Randomized Controlled TrialLongitudinal Functional Connectome In Pediatric Concussion: An A-CAP Study.
Advanced magnetic resonance imaging (MRI) techniques indicate that concussion (i.e., mild traumatic brain injury) disrupts brain structure and function in children. However, the functional connectivity of brain regions within global and local networks (i.e., functional connectome) is poorly understood in pediatric concussion. This prospective, longitudinal study addressed this gap using data from the largest neuroimaging study of pediatric concussion to date to study the functional connectome longitudinally after concussion as compared with mild orthopedic injury (OI). ⋯ Moreover, those regional alterations were especially apparent at later time periods post-injury, emerging after post-concussive symptoms resolved in most and persisted up to 6 months post-injury, and differed by biological sex. This indicates that neurobiological changes continue to occur up to 6 months after pediatric concussion, although changes emerge earlier in females than in males. Changes could reflect neural compensation mechanisms.
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Journal of neurotrauma · Dec 2023
Randomized Controlled TrialCollaborative care versus usual care to improve quality of life, pain, depression, and physical activity in outpatients with spinal cord injury: The SCI-CARE randomized controlled clinical trial.
Our goal was to test the effectiveness of collaborative care (CC) versus usual care (UC) to improve treatment of pain, depression, physical inactivity, and quality of life in outpatients with spinal cord injury (SCI). We conducted a single blind parallel group randomized controlled trial. The setting was two outpatient SCI rehabilitation clinics within a large academic medical center. ⋯ The primary analysis, a mixed-effects linear regression adjusting for time since injury and sex, revealed a non-significant trend for greater improvement in quality of life in CC versus UC at 4 months (p = 0.083). Secondary analyses showed that those receiving CC reported significantly greater improvement in pain interference at 4- and 8-months and in depression at 4-months, but no significant effect on physical activity. We conclude that in an outpatient SCI care setting, CC is a promising model for delivering integrated medical and psychological care and improving management of common, chronic, disabling conditions such and pain and depression.
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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.