University of Kansas Hospital

To evaluate whether disparities in stroke incidence by neighborhood socioeconomic status (nSES) have increased, decreased, or remained unchanged from 2010 to 2015.

We sought to identify the optimal cut-points of NIHSS at initial presentation that correlate with higher 30-day mortality.

Spinal cord stimulation (SCS) at 10 kHz (10-kHz SCS) is a safe and effective therapy for treatment of chronic low-back pain. However, it is unclear from existing evidence whether these findings can be generalized to patients with chronic back pain that is refractory to conventional medical management (CMM) and who have no history of spine surgery and are not acceptable candidates for spine surgery. The authors have termed this condition "nonsurgical refractory back pain" (NSRBP) and conducted a multicenter, randomized controlled trial to compare CMM with and without 10-kHz SCS in this population. Patients with NSRBP, as defined above and with a spine surgeon consultation required for confirmation, were randomized 1:1 to patients undergoing CMM with and without 10-kHz SCS. CMM included nonsurgical treatment for back pain, according to physicians' best practices and clinical guidelines. Primary and secondary endpoints included the responder rate (≥ 50% pain relief), disability (Oswestry Disability Index [ODI]), global impression of change, quality of life (EQ-5D-5L), and change in daily opioid use and were analyzed 3 and 6 months after randomization. The protocol allowed for an optional crossover at 6 months for both arms, with observational follow-up over 12 months. In total, 159 patients were randomized; 76 received CMM, and 69 (83.1%) of the 83 patients who were assigned to the 10-kHz SCS group received a permanent implant. At the 3-month follow-up, 80.9% of patients who received stimulation and 1.3% of those who received CMM were found to be study responders (primary outcome, ≥ 50% pain relief; p < 0.001). There was also a significant difference between the treatment groups in all secondary outcomes at 6 months (p < 0.001). In the 10-kHz SCS arm, outcomes were sustained, including a mean 10-cm visual analog scale score of 2.1 ± 2.3 and 2.1 ± 2.2 and mean ODI score of 24.1 ± 16.1 and 24.0 ± 17.0 at 6 and 12 months, respectively (p = 0.9). In the CMM arm, 74.7% (56/75) of patients met the criteria for crossover and received an implant. The crossover arm obtained a 78.2% responder rate 6 months postimplantation. Five serious adverse events occurred (procedure-related, of 125 total permanent implants), all of which resolved without sequelae. The study results, which included follow-up over 12 months, provide important insights into the durability of 10-kHz SCS therapy with respect to chronic refractory back pain, physical function, quality of life, and opioid use, informing the current clinical practice for pain management in patients with NSRBP.

Retrospective cohort study of a prospectively collected multi-center database of adult spinal deformity (ASD) patients. We hypothesized that patients undergoing ASD surgery with and without previous spinal cord stimulators (SCS)/ intrathecal medication pumps (ITP) would exhibit increased complication rates but comparable improvement in health-related quality of life. ASD patients sometimes seek pain management with SCS or ITP before spinal deformity correction. Few studies have examined outcomes in this patient population. Patients undergoing ASD surgery and eligible for 2-year follow-up were included. Preoperative radiographs were reviewed for the presence of SCS/ITP. Outcomes included complications, Oswestry Disability Index (ODI), Short Form-36 Mental Component Score, and SRS-22r. Propensity score matching was utilized. In total, of 1034 eligible ASD patients, a propensity score-matched cohort of 60 patients (30 with SCS/ITP, 30 controls) was developed. SCS/ITP were removed intraoperatively in most patients (56.7%, n = 17). The overall complication rate was 80.0% versus 76.7% for SCS/ITP versus control (P > 0.2), with similarly nonsignificant differences for intraoperative and infection complications (all P > 0.2). ODI was significantly higher among patients with SCS/ITP at baseline (59.2 vs. 47.6, P = 0.0057) and at 2-year follow-up (44.4 vs. 27.7, P = 0.0295). The magnitude of improvement, however, did not significantly differ (P = 0.45). Similar results were observed for SRS-22r pain domain. Satisfaction did not differ between groups at either baseline or follow-up (P > 0.2). No significant difference was observed in the proportion of patients with SCS/ITP versus control reaching minimal clinically important difference in ODI (47.6% vs. 60.9%, P = 0.38). Narcotic usage was more common among patients with SCS/ITP at both baseline and follow-up (P < 0.05). ASD patients undergoing surgery with SCS/ITP exhibited worse preoperative and postoperative ODI and SRS-22r pain domain; however, the mean improvement in outcome scores was not significantly different from patients without stimulators or pumps. No significant differences in complications were observed between patients with versus without SCS/ITP.Level of Evidence: 3.

One major advantage of developing large, federally funded networks for clinical research in neurology is the ability to have a trial-ready network that can efficiently conduct scientifically rigorous projects to improve the health of people with neurologic disorders. National Institute of Neurological Disorders and Stroke Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) was established in 2011 and renewed in 2018 with the goal of being an efficient network to test between 5 and 7 promising new agents in phase II clinical trials. A clinical coordinating center, data coordinating center, and 25 sites were competitively chosen. Common infrastructure was developed to accelerate timelines for clinical trials, including central institutional review board (a first for the National Institute of Neurological Disorders and Stroke), master clinical trial agreements, the use of common data elements, and experienced research sites and coordination centers. During the first 7 years, the network exceeded the goal of conducting 5 to 7 studies, with 9 funded. High interest was evident by receipt of 148 initial applications for potential studies in various neurologic disorders. Across the first 8 studies (the ninth study was funded at end of initial funding period), the central institutional review board approved the initial protocol in a mean (SD) of 59 (21) days, and additional sites were added a mean (SD) of 22 (18) days after submission. The median time from central institutional review board approval to first site activation was 47.5 days (mean, 102.1; range, 1-282) and from first site activation to first participant consent was 27 days (mean, 37.5; range, 0-96). The median time for database readiness was 3.5 months (mean, 4.0; range, 0-8) from funding receipt. In the 4 completed studies, enrollment met or exceeded expectations with 96% overall data accuracy across all sites. Nine peer-reviewed manuscripts were published, and 22 oral presentations or posters and 9 invited presentations were given at regional, national, and international meetings. NeuroNEXT initiated 8 studies, successfully enrolled participants at or ahead of schedule, collected high-quality data, published primary results in high-impact journals, and provided mentorship, expert statistical, and trial management support to several new investigators. Partnerships were successfully created between government, academia, industry, foundations, and patient advocacy groups. Clinical trial consortia can efficiently and successfully address a range of important neurologic research and therapeutic questions.

1Denver, CO 2The University of Kansas Hospital 3University of Kansas Medical Center, Kansas City, KS 4Kansas City, KS