Clinical Trials

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 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 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 results, further translational research is needed to validate these findings. The goal of this proposal is to perform epidural stimulation to restore volitional function in patients with SCI. In two patients, we will implant an epidural stimulator onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program of daily physical rehabilitation, treadmill step training, and epidural stimulation to recover motor, sensory, and autonomic function.

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 after injury. Secondary objectives are to evaluate the effects of riluzole on overall neurologic recovery, sensory recovery, functional outcomes, quality of life outcomes, health utilities, mortality, and adverse events. The working hypothesis is that the riluzole treated subjects will experience superior motor, sensory, functional, and quality of life outcomes as compared to those receiving placebo, with an acceptable safety profile.

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.

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 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 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 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.

The purpose of this study is to provide confirmatory evidence that use of the LIFT System, inclusive of all components and accessories, is safe; to provide confirmatory evidence that use of the LIFT System provides an effective treatment for the restoration or improvement in UE strength and function; and to provide data regarding the potential benefits of the LIFT System to achieve other secondary outcomes such as improvement in pain, spasticity, quality of life, cardiovascular (blood pressure) and autonomic function.