Neurosurgery
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Review
Digital Biomarkers and the Evolution of Spine Care Outcomes Measures: Smartphones and Wearables.
Over the past generation, outcome measures in spine care have evolved from a reliance on clinician-reported assessment toward recognizing the importance of the patient's perspective and the wide incorporation of patient-reported outcomes (PROs). While patient-reported outcomes are now considered an integral component of outcomes assessments, they cannot wholly capture the state of a patient's functionality. There is a clear need for quantitative and objective patient-centered outcome measures. ⋯ The patterns emerging from these data, so-called "digital biomarkers," can accurately describe characteristics of a patient's health, disease, or recovery state. Broadly, the spine care community has thus far concentrated on digital biomarkers related to mobility, although the researcher's toolkit is anticipated to expand in concert with advancements in technology. In this review of the nascent literature, we describe the evolution of spine care outcome measurements, outline how digital biomarkers can supplement current clinician-driven and patient-driven measures, appraise the present and future of the field in the modern era, as well as discuss present limitations and areas for further study, with a focus on smartphones (see Supplemental Digital Content , http://links.lww.com/NEU/D809 , for a similar appraisal of wearable devices).
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Traumatic brain injury (TBI) remains a leading cause of death and disability, affecting approximately 69 million individuals each year worldwide. A significant portion of TBI research has focused on treatments for neuroprotection and/or neurorecovery, with most failing to transition to successful clinical applications despite promising animal/in vitro study results. MLC901 (NeuroAiD II), with origins from a traditional Chinese medicine, has been shown to exhibit both neuroprotective and neuroregenerative properties in in vitro and animal studies for stroke and TBI. Clinical trials have demonstrated its safety with significant improvements in some functional outcome and cognitive domain measures. The objective of this study is to determine the efficacy and safety of MLC901 (NeuroAiD II) vs placebo in adult patients with moderate TBI. ⋯ Previous studies on the effect of MLC901 in adult patients with moderate TBI showed positive results; However, these studies are limited by the small number of patients. This study will establish a more definitive role of MLC901 in improving functional and cognitive outcomes in patients with moderate TBI.