A Single-Blind, Randomized, Parallel Arm, Phase II Proof-of-Concept Study of the Safety and Efficacy of HuCNS-SC Transplantation in Cervical Spinal Cord Injury (Pathway Study)

One of the greatest challenges associated with SCI is that most of these injuries result in irreversible loss of movement and sensation beyond the point of injury. One potential treatment option being evaluated in research studies is stem cell therapy. The stem cells used in the Pathway Study are neural stem cells, which can replicate and become one of three types of nerve cells. These nerve cells make up the brain and the spinal cord. The Pathway Study is testing the safety and potential benefit of a very specific type of stem cell known as a neural stem cell, also called HuCNS-SC®. Neural stem cells come from brain tissue and have the ability to self-renew and become the main types of mature cells found in the brain and spinal cord.

The Pathway Study is a larger clinical study designed to determine if HuCNS-SC® can result in recovery of function in patients with spinal cord injury.

Authors: Jeffrey Rosenbluth, MD, in collaboration with Andrew Dailey, MD

Detecting Autologous Transfusion by Measuring Alterations in Red Blood Cell Maturation and Recycling Dynamics

Autologous transfusion refers to the removal of an individual’s blood and re-infusing that blood into the same individual at a later time. As this re-infusion results in an increase in red blood cells (RBC), hemoglobin (protein responsible for transporting oxygen in the red blood cells), and hematocrit (percentage of the blood that is comprised of red blood cells) and can thus enhance oxygen delivery throughout the body. Autologous blood transfusions are banned by the World Anti-Doping Agency (WADA) for use by athletes. The study’s goal is to evaluate new detection methods for autologous blood transfusion in athletes.

Authors: Daniel Cushman, MD and Stuart Willick, MD

Outcomes in Children with Mild TBI vs. Complicated Mild TBI

Concussions, or Traumatic Brain Injuries, have become a significant public health concern. However, there is very little research to inform the medical community of how children do years after they have sustained a head injury. For example, whether or not such children are at heightened risk of future concussions if they re-engage in sports, or if they encounter particular academic difficulties even years later. This survey study will help us begin to answer some of these questions.

Author: Colby Hansen, MD

The Influence of Physical Therapist-Patient Relationships on Emotional and Physical Outcomes Among Persons with New Spinal Cord Injury

The purpose of the study is to better understand how relationships between physical therapists and individuals with new spinal cord injury impact physical and psychological well-being.

Author: Justin MacKenzie, PhD

Analysis of Electromyographic, Goniometric, and Force Plate Data in Skiers, Snowboarders, and Speed Skaters

Muscle strength, muscle efficiency, and the timing of muscle activation and relaxation are crucial factors in athletic performance. Muscle activation and relaxation patterns have been shown to be different among elite vs. non-elite athletes performing the same tasks. Furthermore, certain muscle activation patterns have shown alterations after injury. Surface electromyography has long been utilized to study muscle function in normal and diseased states in the laboratory setting.

Over recent years, significant technological advances have made it possible to study muscle function during dynamic activities in non-laboratory settings. Two key advances have been improved: signal-to-noise ratio and diminishing size of data storage devices. This study aims to document muscle activation and relaxation patterns among elite and sub-elite alpine skiers, nordic skiers, snowboarders, freestyle skiers and speed skaters. Surface EMG data will be linked to goniometric data at the ankle, knee, and hip, and also to force data measured within the ski or snowboard boot and skate.

Authors: Stuart Willick, MD, in collaboration with Charlie Hicks-Little, PhD

Utah Ski And Snowboard Injury Surveillance System

Skiing and snowboarding are inherently dangerous sports. The objective of this project is to collect survey data in the general population of skiers and snowboarders at the Park City Ski Resort. This data will include basic demographic information that will be linked to the ongoing retrospective chart review at the Park City Ski Clinic during the 2009–2010 season. The information collected by these surveys will be considered pilot data for a feasibility study on implementing a long-term injury surveillance system. By collecting data from the uninjured population we can gain a better understanding of the various factors associated with injuries, and injury trends over time, in this athletic population. By identifying modifiable mechanisms of injury, we hope to then devise and implement injury reduction programs. A long-term injury surveillance system will then allow us to test the efficacy of the injury prevention strategies.

Author: Stuart Willick, MD

Community-Based Health Interventions: Decreasing Secondary Conditions Associated With SCI

Prior research examining community integration and adults with spinal cord injury (SCI) has focused on quality of life, psychosocial benefits, and social integration. This research has shown that decline in community reintegration is linked to physical independence, social integration, and health status. Few studies have examined how community health addresses secondary health conditions with SCI. In one research study subjects indicated that although they appreciated and understood the importance of the rehabilitation process to a healthy lifestyle, the current health care system was not relevant to the needs of the individual with SCI. Furthermore, it has been demonstrated that individuals with SCI who experienced secondary health conditions associated with the SCI believed that over 34.1% were preventable if the correct outpatient treatment was in place. Therefore, the purpose of this study is to examine what types of community integration programs for persons with SCI actually decrease secondary health conditions (such as pressure sores, urinary tract infections, pain), physician visits, and inpatient hospital stays.

Authors: Jeffrey Rosenbluth, MD, in collaboration with Jennifer Piatt, PhD, Indiana University

Sildenafil and Stroke Recovery

The aim of this study is to determine safety, feasibility, and effect on stroke recovery of administering sildenafil to participants with acute stroke. We expect that we will be able to recruit our target number of participants, demonstrate that it is feasible to retain them in the study without serious adverse effects related to the study or side effects uncomfortable enough to cause them to drop out of the study, and that we will be able to calculate a valid effect size for each group. An additional purpose of this study is to examine the brain white matter and activation changes in the motor system following this therapy in order to delineate neural mechanisms of stroke recovery associated with this therapy.

Authors: Steven Edgley, MD, in collaboration with Lorie Richards, PhD

Implantable System Performance Registry (ISPR)/Product Surveillance Registry (PSR)

The Implantable System Performance Registry (ISPR)/Product Surveillance Registry (PSR) is a web-based outcome registry designed to monitor the product performance of Medtronic Infusion Systems. The objectives of ISPR are to evaluate and quantify implantable system, device-related, adverse, event-free survival based on ISPR events and to collect data that may identify the cause of device failure. ISPR data may be used to fulfill regulatory requirements and guide future produce development and product reliability.

Author: Allison Oki, MD

Hyperhidrosis of the Residual Limb in Patients With Amputations: Developing a Treatment Approach

The purpose of this project is to develop a treatment approach addressing the problem of hyperhidrosis of the residual limb in patients with amputations. Excessive sweating of the residual limb is a common complaint in prosthetic users, but there is a lack of published information regarding evaluation and treatment of this problem. Successful use of a prosthesis requires a stable interface between the residual limb and the prosthetic socket. Naturally, maintaining healthy skin is paramount for an amputee patient to successfully use a prosthesis. However, the closed environment that is necessary to provide this stability also creates an environment, which may lead to a multitude of skin problems.

Author: Bradeigh Godfrey, DO

Utility of the FireScan in the Diagnosis of Axial Spine Pain

The objective of this case series is to describe the clinical utility of this new imaging technique in the diagnosis of patients with axial spine pain. Axial spine pain is a common condition with a broad differential diagnosis. Despite a thorough history and physical examination, it is often difficult to determine a specific pain generator with 100% certainty. Preliminary data is available on an emerging imaging technology that potentially can assist in the localization of axial spine pain. The imaging technique, which has been referred to by some as a “FireScan,” involves the digital fusion or overlay of a CT scan of the area of interest with a bone scan with SPECT imaging. The FireScan provides the anatomic resolution of the CT scan plus the sensitivity of the bone scan.

Author: Stuart Willick, MD

Injury Surveillance Among Masters Level Ski Racers

The sport of alpine ski racing is inherently dangerous. Recent sports injury epidemiology research from the International Ski Federation (FIS) indicates that the injury rate among World Cup ski racers is upwards of 45% per year. (ref 1-5). To date, there are no reports in the medical literature regarding injuries associated with Masters Ski Racing. We will be using an online survey to ascertain injury rates among Masters level ski racers. Masters skiers tend to be an older group of skiers, many of whom have competed for 20 plus years and still ski competitively. Injury rates are thought to be high among this group of individuals.

Author: Stuart Willick, MD

Injuries During The 2014 USA Cycling Cyclo-cross National Championships

The purpose of this study is to distribute an online survey tool to collect and analyze data about the incidence and different types of injuries that occur during a cyclo-cross race.

Authors: Alexandra Flis, MD and Stuart Willick, MD

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