Clinical Trials

The purpose of this study is to determine if mesenchymal stem cells (MSC) derived from the fat tissue can be safely administered into the cerebrospinal fluid (CSF) of patients with spinal cord injury. Adipose-derived mesenchymal stem cells (AD-MSCs) have been used in previous research studies at the Mayo Clinic. All subjects enrolled in this study will receive AD-MSC treatment, which is still experimental and is not approved by the U.S. Food and Drug Administration (FDA) for large scale use. However, the FDA has allowed the use of this agent in this research study.

The aim of this study is to evaluate efficacy and safety of riluzole in the treatment of patients with acute SCI. The primary objective is to evaluate the superiority of riluzole, at a dose of 2 x 100 mg the first 24 hours followed by 2 x 50 mg for the following 13 days after injury, as compared to placebo, in change between 180 days and baseline in motor outcomes as measured by International Standards for Neurological Classification of Spinal Cord Injury Examination (ISNCSCI) Motor Score, in patients with acute traumatic SCI, presenting to the hospital less than 12 hours ...

The purpose of this study is to characterize and compare sensorimotor activity in muscles below the level of injury during Transcutaneous Epidural Spinal Stimulation (TESS) and Epidural Electrical Stimulation (EES)-enabled motor tasks, and to assess and compare changes in clinical outcomes over the course of rehabilitation with TESS and EES.

This will be a prospective registry conducted and maintained at Mayo Clinic Rochester from which collaborating sites within Mayo, Mayo Health Systems, and other spinal cord injury centers can draw from in order to fulfill research enrollment. The information collected for this registry will be used for recruitment purposes only, and will not be used as research data. Participants who are recruited to participate in other research studies will need to complete a separate consenting/enrollment process specific to that study.

The purpose of this study is to determine the rate at which patients who underwent Spinal Cord Stimulation (SCS) trial ultimately progressed to SCS implantation, determine the percentage of patients who continued using their SCS system after 5 years, as well as identify patient characteristics that lead to SCS discontinuation.

This is a feasibility study to test the use of epidural stimulation to restore volitional function previously lost due to spinal cord injury. Previous studies conducted in animal models, performed elsewhere and here at Mayo Clinic, have shown that direct electrical stimulation of the spinal cord increases the excitability of spared neuronal connections within the site of injury, thereby enhancing signal transmission and allowing recovery of previously lost volitional function. Recently, epidural electrical stimulation of the lumbosacral spinal cord in four individuals with spinal cord injury (SCI) has restored motor and autonomic function below the level of injury. Despite positive ...

The purpose of this study is to compare the effectiveness of intravenous (IV) infusions of MT-3921 to placebo in treatment of subjects with acute traumatic cervical spinal cord injury.  The study assesses the effect of MT-3921 on sensory and motor impairment, prehension impairment, and functional outcomes and independence in activities of daily living and quality of life, the safety and tolerability of MT-3921, and will characterize the pharmacokinetics profile of MT-3921 following multiple-dose administration in subjects with spinal cord injury.

The purpose of this study is to produce preliminary data testing the feasibility and effectiveness of high intensity interval training (HIIT) on cardiovascular health parameters in individuals with paraplegia.

A study to compare electrophysiologic activity of epidural stimulation and dorsal root ganglion stimulation, as well as quantify changes in motor performance with both types of stimulation over the course of 10 rehabilitation sessions.

The objective of this proposal is to use kinematic-driven modeling approach to identify the risk of impingement during activities of daily living and ambulation with a wheelchair and gait aids across levels of functional ambulation independence.

The purpose of this study is to determine whether meeting the physical activity guidelines for cardiometabolic health is associated with positive health-related outcomes.

Additionally to determine whether meeting the physical activity guidelines for cardiometabolic health is associated with positive psychosocial outcomes, and determine whether meeting the physical activity guidelines for cardiometabolic health is associated with greater social and occupational integration.  

The purpose of the present study is to investigate the safety and efficacy of a single intrathecal injection of autologous, culture expanded AD-MSCs specifically in subjects with severe traumatic SCI when compared to patients undergoing physical therapy.

This is a survey study to identify user-reported motor, sensory, and autonomic functions that are enabled by epidural stimulation, establish correlations between epidural stimulation usage, rehabilitation, functional gains, and user experience in the laboratory and community settings, and to understand and identify subjective goals, benefits, and barriers that still exist with implanted epidural stimulator community.

The proposed study is intended to inform the hypotheses that (1) regular dosing of exoskeleton walking will provide health benefits to non-ambulatory and poorly-ambulatory individuals with SCI, including decreased pain and spasticity, improvements in bowel and bladder function, decreased body-mass index (BMI), enhanced well-being; (2) regular dosing of exoskeleton walking will facilitate neurological or functional recovery in some individuals with SCI, particularly those with incomplete injuries; and (3) the level of mobility enabled by a lower limb exoskeleton is commensurate with the walking speeds, distances, and surfaces required for community ambulation.

The objectives of this study are to determine the effect of Human Umbilical Cord MSCs Derived Exosome / Extracellular Vesicle (uEV) on adult neural stem cells (NSCs) in-vito, and to assess the functional benefit of human uEV treatment on rats with spinal cord injury.

The purpose of this study is to contribute to the Spinal Cord Injury Model Systems (SCIMS) national database through longitudinal assessment of long-term health and psychosocial outcomes after acquired spinal cord injury (SCI). 

The purpose of this study is to compare transcutaneous electrical spinal stimulation and epidural electrical spinal stimulation.  Relationships between stimulation input and electrophysiological output will be recorded, and changes in motor, sensory, and functional outcomes during and after stimulation will be assessed.

Researchers are trying to evaluate and recommend sustainable and effective health and wellness programs for people with spinal cord injury (SCI) and other physical disabilities.

CSM (Cervical spondylotic myelopathy) is the most common cause of spinal cord injury worldwide. While there is evidence from the recently completed SpineNet prospective study that surgical decompression is an effective treatment for CSM, it is clear that many patients have remaining neurological impairment. While surgery is relatively safe, approximately 3% of patients maintain a neurological problem. Given this background and data from preclinical models of non-traumatic and traumatic spinal cord injury, there is strong evidence to consider the potential benefit of adding a neuroprotective drug which aids in the treatment of patients with CSM whom are undergoing surgical decompression. ...

The purpose of this study is to determine if use of a pressure mapping device used in daily life results in behaviors that reduce the risk for developing a pressure ulcer.

The purpose of this study is to provide wheelchair users with personal-use technology that provides effective feedback to increase movement to prevent pressure injuries across all 3 parts of the study.

The purpose of this study is to develop a pattern recognition algorithm for manual wheelchair related activities of daily living. This study also aims to identify shoulder impingement risk score of MWC-related ADLs and determine cumulative shoulder impingement risk of MWC-related ADLs.

The purpose of this study is to provide wheelchair users with personal-use technology that provides effective feedback to increase movement to prevent pressure injuries.