Clinical Research Directory

Novel Soluble Epoxide Hydrolase Inhibitor for Neuropathic Pain in Patients With Spinal Cord Injury

The goal of this clinical trial is to evaluate safety and tolerability of multiple oral doses of EC5026 in male and female patients with neuropathic pain due to traumatic or non-traumatic (degenerative) spinal cord injury. The main question it aims to answer is whether EC5026 is safe and well tolerated in SCI patients with neuropathic pain. In addition, this trial will also study the effects of EC5026 on pain. Researchers will compare EC5026 to placebo. Participants will be asked to: * Take EC5026 or placebo in a masked fashion, once daily, for 14 consecutive days. * Undergo physical exams, vital signs assessments, ECGs, and blood draws * Complete assessments of pain, sleep, functional status, and perception of change

Dose Responsiveness as a Measure of Clinical Effectiveness During Neuromonitored Spine Surgery

Intraoperative Neuromonitoring (IONM) is a tool used by neurophysiologists during spine surgery to prevent irreversible damage to the spinal cord during procedures through a system of alerts. This study investigates the effectiveness of IONM in 300 participants receiving spine surgery. The goal of this study is to refine the alert criteria for procedures in which IONM is used.

Proprio Spine Measurement Tool

This study will prospectively collect data to evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with intraoperatively achieving pre-planned alignment-related parameters to the patient's spine. The study will also collect outcomes data to determine if achievement of these spinal alignment-related parameters result in satisfactory outcomes and if it reduces the rate of secondary surgeries. Objectives Primary: To evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with achieving the surgeon's preplanned alignment-related parameters intraoperatively. Secondary: To determine if there is a correlation between 1) achievement of preoperative planned alignment-related parameters intraoperatively, and 2) outcomes. Hypothesis The application of the intraoperative spinal measurement tool for patients undergoing spinal fusion surgery will improve the surgeon's ability to achieve pre-planned alignment-related parameters intraoperatively and doing so will provide improved outcomes.

Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®

The aim of this study is to prospectively investigate the potential for bony fusion of ViviGen® bone graft substitute in comparison to rhBMP-2 in monosegmental ALIF procedure L5/S1 and in monosegmental XLIF procedure L4/5

CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study

The study is a prospective, first-in-human, multi-center, non-randomized, single-arm study to assess the safety and efficacy of the CEM-Cage used with the CEM-Plate in patients who are appropriate candidates for a 2-level anterior cervical discectomy and fusion (ACDF). Fifty patients will be enrolled in the study and, after undergoing a 2-level ACDF, will be evaluated at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.

Recording of Intraoperative Spinal Cord Stimulation and Monitoring

Opioid overdose suppresses brainstem respiratory circuits, causes apnea, and may result in death. Epidural electrical stimulation (EES) at the cervical spinal cord facilitated motor activity in rodents and humans, and we hypothesized that EES of the cervical spinal cord could antagonize opioid-induced respiratory depression in humans. In this study, we will stimulate the spinal cord during surgery and assess its effects on respiratory function in human patients.

PREventing Pain After Surgery

The present study aims to adapt and modify a brief presurgical Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Investigators will then assess the acceptability, feasibility, and preliminary efficacy of the finalized intervention to prevent the transition to CPSP and reduce post-surgical opioid use six months following lumbar spine surgery. Finally, investigators will identify psychosocial and psychophysical phenotypes associated with response to this intervention.