Prediction of segmental motor outcomes in traumatic spinal cord injury: Advances beyond sum scores.

Background And Objectives: Neurological and functional recovery after traumatic spinal cord injury (SCI) is highly challenged by the level of the lesion and the high heterogeneity in severity (different degrees of in/complete SCI) and spinal cord syndromes (hemi-, ant-, central-, and posterior cord). So far outcome predictions in clinical trials are limited in targeting sum motor scores of the upper (UEMS) and lower limb (LEMS) while neglecting that the distribution of motor function is essential for functional outcomes. The development of data-driven prediction models of detailed segmental motor recovery for all spinal segments from the level of lesion towards the lowest motor segments will improve the design of rehabilitation programs and the sensitivity of clinical trials.

Studying missingness in spinal cord injury data: challenges and impact of data imputation.

Background: In the last decades, medical research fields studying rare conditions such as spinal cord injury (SCI) have made extensive efforts to collect large-scale data. However, most analysis methods rely on complete data. This is particularly troublesome when studying clinical data as they are prone to missingness.

Early vs Late Surgical Decompression for Central Cord Syndrome.

Importance: The optimal clinical management of central cord syndrome (CCS) remains unclear; yet this is becoming an increasingly relevant public health problem in the face of an aging population.

Objective: To provide a head-to-head comparison of the neurologic and functional outcomes of early (<24 hours) vs late (≥24 hours) surgical decompression for CCS.

Design, Setting, And Participants: Patients who underwent surgery for CCS (lower extremity motor score [LEMS] - upper extremity motor score [UEMS] ≥ 5) were included in this propensity score-matched cohort study.

A Novel Method to Classify Cervical Incomplete Spinal Cord Injury Based on Potential for Recovery: A Group-Based Trajectory Analysis.

The outcomes of cervical incomplete spinal cord injury (SCI) are heterogeneous. This study sought to dissociate subgroups of cervical incomplete SCI patients with distinct longitudinal temporal profiles of recovery in upper limb motor function. Patients with cervical incomplete SCI (American Spinal Injury Association Impairment Scale [AIS] B-D; C1-C8) were identified from four prospective, multi-center SCI datasets.

International surveillance study in acute spinal cord injury confirms viability of multinational clinical trials.

Background: The epidemiological international landscape of traumatic spinal cord injury (SCI) has evolved over the last decades along with given inherent differences in acute care and rehabilitation across countries and jurisdictions. However, to what extent these differences may influence neurological and functional recovery as well as the integrity of international trials is unclear. The latter also relates to historical clinical data that are exploited to inform clinical trial design and as potential comparative data.

A New Score Based on the International Standards for Neurological Classification of Spinal Cord Injury for Integrative Evaluation of Changes in Sensorimotor Functions.

Sensorimotor function of patients with spinal cord injury (SCI) is commonly assessed according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). From the ISNCSCI segmental motor and sensory assessments, upper and lower extremity motor scores (UEMS and LEMS), sum scores of pinprick (PP) and light touch (LT) sensation, the neurological level of injury (NLI) and the classification of lesion severity according to the American Spinal Injury Association Impairment Scale (AIS) grade are derived. Changes of these parameters over time are used widely to evaluate neurological recovery.

Trajectory-Based Classification of Recovery in Sensorimotor Complete Traumatic Cervical Spinal Cord Injury.

Objective: To test the hypothesis that sensorimotor complete traumatic cervical spinal cord injury (SCI) is a heterogenous clinical entity comprising several subpopulations that follow fundamentally different trajectories of neurologic recovery.

Methods: We analyzed demographic and injury data from 655 patients who were pooled from 4 prospective longitudinal multicenter studies. Group-based trajectory modeling was applied to model neurologic recovery trajectories over the initial 12 months postinjury and to identify predictors of recovery trajectories.

Routine Blood Chemistry Predicts Functional Recovery After Traumatic Spinal Cord Injury: A Post Hoc Analysis.

Background: Spinal cord injury (SCI) leads to various degrees of lifelong functional deficits. Most individuals with incomplete SCI experience a certain degree of functional recovery, especially within the first-year postinjury. However, this is difficult to predict, and surrogate biomarkers are urgently needed.

The influence of timing of surgical decompression for acute spinal cord injury: a pooled analysis of individual patient data.

Background: Although there is a strong biological rationale for early decompression of the injured spinal cord, the influence of the timing of surgical decompression for acute spinal cord injury (SCI) remains debated, with substantial variability in clinical practice. We aimed to objectively evaluate the effect of timing of decompressive surgery for acute SCI on long-term neurological outcomes.

Methods: We did a pooled analysis of individual patient data derived from four independent, prospective, multicentre data sources, including data from December, 1991, to March, 2017.

Nerve Root Sedimentation Sign: Can It Predict the Success for Surgical Intervention in Patients With Symptomatic Lumbar Spinal Stenosis?

Introduction:  The use of interspinous process devices are less invasive surgical methods designed to manage mild to moderate lumbar spinal stenosis symptoms. Symptomatic relief may not be seen in all patients undergoing this procedure. Magnetic resonance imaging (MRI) parameters have been used to predict the success of clinical outcomes in patients with symptomatic lumbar spinal stenosis for decompressive surgeries.

Serum albumin as a predictor of neurological recovery after spinal cord injury: a replication study.

Study Design: This was a secondary analysis on an observational cohort study.

Objective: To determine if serum albumin significantly associates with long-term neurological outcome (i.e.

Gangliosides: Treatment Avenues in Neurodegenerative Disease.

Gangliosides are cell membrane components, most abundantly in the central nervous system (CNS) where they exert among others neuro-protective and -restorative functions. Clinical development of ganglioside replacement therapy for several neurodegenerative diseases was impeded by the BSE crisis in Europe during the 1990s. Nowadays, gangliosides are produced bovine-free and new pre-clinical and clinical data justify a reevaluation of their therapeutic potential in neurodegenerative diseases.

The Effect of Non-Gabapentinoid Anticonvulsants on Sensorimotor Recovery After Human Spinal Cord Injury.

Background: Recent observational studies have shown an association between gabapentinoid anticonvulsants and greater motor recovery after spinal cord injury. There is preclinical evidence to suggest that other anticonvulsants, such as sodium channel blockers, may also confer beneficial effects.

Purpose: The aim of the current study was to determine if non-gabapentinoid anticonvulsants were associated with neurological recovery after acute, traumatic spinal cord injury.

A Longitudinal Study of the Neurologic Safety of Acute Baclofen Use After Spinal Cord Injury.

The objective of our study was to determine whether treatment with baclofen is neurologically safe with respect to exposure during recovery from spinal cord injury. We performed a secondary longitudinal analysis of a cohort of adult patients with traumatic acute spinal cord injury. Cumulative baclofen dose was computed over the first 4 weeks following injury from concomitant medication information from a completed clinical trial.

Interspinous Process Decompression Improves Quality of Life in Patients with Lumbar Spinal Stenosis.

Lumbar spinal stenosis has been shown to negatively impact health-related quality of life. Interspinous process decompression (IPD) is a minimally invasive procedure that utilizes a stand-alone spacer to serve as a joint extension blocker to relieve neural compression in patients with spinal stenosis. Using the 5-year results from an FDA randomized controlled trial of IPD, the quality of life in 189 patients treated with the Superion® spacer was evaluated with the SF-12.

Serum Albumin Predicts Long-Term Neurological Outcomes After Acute Spinal Cord Injury.

Background: There is a need to identify reliable biomarkers of spinal cord injury recovery for clinical practice and clinical trials.

Objective: Our objective was to correlate serum albumin levels with spinal cord injury neurological outcomes.

Methods: We performed a secondary analysis of patients with traumatic spinal cord injury (n = 591) participating in the Sygen clinical trial.

Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis.

Background: Lumbar spinal stenosis is the most common indication for spine surgery in older adults. Interspinous process decompression (IPD) using a stand-alone spacer that functions as an extension blocker offers a minimally invasive treatment option for intermittent neurogenic claudication associated with spinal stenosis.

Methods: This study evaluated the 5-year clinical outcomes for IPD (Superion) from a randomized controlled US Food and Drug Administration (FDA) noninferiority trial.

Superion Interspinous Spacer Treatment of Moderate Spinal Stenosis: 4-Year Results.

Objective: To determine 4-year clinical outcomes in patients with moderate lumbar spinal stenosis treated with minimally invasive stand-alone interspinous process decompression using the Superion device.

Methods: The 4-year Superion data were extracted from a randomized, controlled Food and Drug Administration investigational device exemption trial. Patients with intermittent neurogenic claudication relieved with back flexion who failed at least 6 months of nonsurgical management were enrolled.

Open Access Platforms in Spinal Cord Injury: Existing Clinical Trial Data to Predict and Improve Outcomes.

Recovery from acute spinal cord injury (SCI) is characterized by extensive heterogeneity, resulting in uncertain prognosis. Reliable prediction of recovery in the acute phase benefits patients and their families directly, as well as improves the likelihood of detecting efficacy in clinical trials. This issue of heterogeneity is not unique to SCI.

Interspinous Process Decompression: Expanding Treatment Options for Lumbar Spinal Stenosis.

Interspinous process decompression is a minimally invasive implantation procedure employing a stand-alone interspinous spacer that functions as an extension blocker to prevent compression of neural elements without direct surgical removal of tissue adjacent to the nerves. The Superion® spacer is the only FDA approved stand-alone device available in the US. It is also the only spacer approved by the CMS to be implanted in an ambulatory surgery center.

Superion(®) InterSpinous Spacer for treatment of moderate degenerative lumbar spinal stenosis: durable three-year results of a randomized controlled trial.

Purpose: This report provides the 3-year clinical outcomes from the randomized, controlled US Food and Drug Administration Investigational Device Exemption trial of the Superion(®) for the treatment of moderate degenerative lumbar spinal stenosis.

Patients And Methods: The Superion(®) was evaluated in the treatment of subjects aged 45 years or older suffering from symptoms of intermittent neurogenic claudication, secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1 to L5. Patients were treated between June 2008 and December 2011 at 31 investigational sites.

Stand-alone interspinous spacer versus decompressive laminectomy for treatment of lumbar spinal stenosis.

Objective: To compare the two-year clinical outcomes of a prospective, randomized controlled trial of an FDA-approved interspinous spacer with the compilation of published findings from 19 studies of decompressive laminectomy for the treatment of lumbar spinal stenosis.

Methods: Back and leg pain, Oswestry disability index (ODI), and Zurich Claudication Questionnaire (ZCQ) values were compared between spacer- and laminectomy-treated patients preoperatively and at 12 and 24 months.

Results: Percentage improvements between baseline and 24 months uniformly favored patients treated with the spacer for back pain (65% vs.