Active clinical trials for "Spinal Cord Injuries"

This study will investigate potential therapeutic approaches for sleep-disordered breathing (SDB) in patients with chronic cervical spine injury (>6 months post-injury).

Texas Biomedical Device Center at UT Dallas has developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury termed targeted plasticity therapy (TPT). This technique uses brief pulses of vagus nerve stimulation to engage pro-plasticity neuromodulatory circuits during rehabilitation exercises. Recovery is associated with neural plasticity in spared motor networks in the brain and spinal cord. Moreover, an early feasibility study and an independent, double-blind, placebo-controlled study in chronic stroke participants indicate that VNS is safe in participants with upper limb deficits, and yields a clinically-significant three-fold increase in neural connections during rehabilitation exercises. Given the track record of safety and potential for VNS to enhance recovery of upper limb motor function in spinal cord injured individuals, the purpose of this double blind randomized placebo controlled optional open-label extension study is to assess the safety of using a new device to deliver vagus nerve stimulation to reduce symptom severity in participants with SCI. Additionally, the study will assess the prospective benefit of the system and garner an initial estimate of efficacy for a subsequent trial. Participants may undergo additional sessions of training with VNS.

Manual wheelchairs allow individuals with spinal cord injuries (SCI) to safely and effectively access their environment. However, continual exposure to whole body vibration (WBV) is one of many contributing factors to neck pain, back pain, and fatigue in wheelchair users with SCI. Vibration-reducing in-wheel suspension has the potential to mitigate issues associated with long-term manual wheelchair propulsion. Evidence is lacking on how well these systems work for reducing harmful shock and vibration, pain and fatigue. The purpose of this study is to examine how these wheels change the vibration levels manual wheelchair users are exposed to and how they impact pain and fatigue.

This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.

The study involves the 'first-in-human' evaluation of a novel optical sensor which uses near-infrared spectroscopy (NIRS) technology to assess oxygenation and hemodynamics of the injured spinal cord. The NIRS sensor is laid on top of the dura, at the site of the SCI, and emits near-infrared light signals into the cord to measure tissue oxygenation and tissue hemodynamics in real-time. Our testing of this novel NIRS sensor in patients with acute SCI represents the first step in translating this technology for human use.

The purpose of this research study is to compare the effect of two different types of education and support programs for partner caregivers of people with spinal cord injury (SCI).

Spinal cord injuries (SCI) are among the most debilitating conditions an individual can sustain with the estimates of SCI incidence in the United States at 12,000 new cases per year. The loss of innervation to the tissues muscle below the level of the lesion results in reduced physical activity which leads to an array of secondary complications including muscle atrophy, cardiovascular and metabolic disease, obesity and vascular dysfunction. This further leads to exercise intolerance, reduced quality of life and depression. Although current rehabilitative programs focus on improving muscle strength in this population, the efficacy of these programs is challenged by the injury related motor impairment, which limits the exercise intensity and subsequent positive muscular adaptations. Therefore, development of an exercise program that promotes maximal muscular adaptations to light intensity exercise could greatly improve the efficacy of rehabilitation in the SCI population and help restore functional capacity and quality of life for these individuals. Blood flow restriction (BFR) exercise has shown tremendous promise for improving muscle size and strength in a variety of healthy and clinical populations, however the benefits of BFR exercise for those with SCI has not been established. Thus, the purpose of this Merit proposal is to conduct a comprehensive study that explores the benefits and risks of BFR exercise in the incomplete SCI population. In general individuals with chronic incomplete SCI will be recruited to partake in two 8-week training periods (20 sessions) that involve traditional knee extension/flexion exercise or knee extension/flexion exercise with blood flow restriction. There will be a series of measurements before and after the 8-week intervention to look at changes in muscle and vascular function. Specific Aim 1 will determine how the 8-weeks of BFR exercise influenced muscle strength (Biodex isokinetic dynamometer), muscle cross sectional area and volume (CTscan) and fatigue resistance. Specific Aim 2 will determine how this novel 8-week training intervention impacts peripheral vascular function. Specifically, changes in nitric oxide mediated endothelial function will be determined through tests of flow mediated dilation, changes in endothelial function of the microvascular network will be determined through assessments of reactive hyperemia and changes in arterial stiffness will be determined through measurements of pulse wave velocity. Specific Aim 3 will focus on the safety of BFR exercise for the SCI population. Those with SCI are at greater risk for thrombosis and DVT compared to able bodied individuals. Although unlikely, the introduction of temporary blood stasis during BFR exercise might augment this risk. Thus, the third aim of this study will be to determine changes in innate immune activation and thrombosis risk. Specifically, blood will be collected at multiple timepoints throughout the training intervention and analyzed for hypoxia-inducible factor 1-alpha, neutrophil extra cellular traps (which act as prothrombotic scaffolds), neutrophil-platelet aggregates and inflammatory cytokines. Ultimately, if the improvements in muscle and vascular function following BFR resistance exercise is greater than the traditional resistance exercise often performed in rehabilitation settings, without increasing risk for DVT, it should be incorporated into the long-term rehabilitation programs for Veterans with SCI.

Spinal cord injury (SCI) leads to several health-related consequences often linked to reduced levels of physical activity. Direct stimulation of the spinal cord, either through implanted devices or surface stimulation, has been combined with intense physical therapy assisted treadmill walking to facilitate independent standing and stepping. These current methods require 3-4 highly skilled therapists and may not be feasible in all rehabilitation settings, especially when considering the growing number of SCI patients each year. Therefore, the use of robotic exoskeleton suits combined with direct stimulation of the spinal cord (requiring 1-2 therapists) may offer an alternative rehabilitation approach to overcome their limited abilities to stand and walk. Such improvements may also help to reverse or eliminate other health-related consequences associated with SCI. The pilot work will provide the preliminary evidence required to design future clinical trials for Veterans and civilians with SCI to restore overground mobility.

People with spinal cord injury (SCI), stroke and other neurodegenerative disorders can follow two pathways for regaining independence and quality of life. One is through clinical interventions, including therapeutic exercises. The other is provided by assistive technologies, such as wheelchairs or robotic systems. In this study, we combine these two paths within a single framework by developing a new generation of body-machine interfaces (BoMI) supporting both assistive and rehabilitative goals. In particular, we focus on the recovery of muscle control by including a combination of motion and muscle activity signals in the operation of the BoMI.

Spinal Cord Injury (SCI) leads to alterations in brain structure and function by spinal nerve damage, secondary inflammatory responses, and by the consequences of living with paralysis and neuropathic pain. Physical inactivity due to lower body paralysis rapidly leads to loss of muscle, and risk of heart disease. The leading cause of death after a spinal cord injury is cardiovascular disease, and just a year after injury, those with SCI have a peak exercise capacity half that of the unfit general population. The good news is that aerobic exercise reduces the risk of chronic metabolic and cardiorespiratory diseases, reduces inflammation and pain, and increases mood and quality of life. Exercise can also reduce brain inflammation, enhance endogenous analgesia, and increases the size of the hippocampus. The issue is that muscle paralysis in SCI restricts the ability to achieve the levels of exercise that is necessary for broad analgesic, anti-inflammatory and neuroprotective benefits. Arm exercise can have some effects on heart and lung capacity, but the small muscle mass is insufficient to produce more than modest aerobic work. With functional electrical stimulation (FES), leg muscles that are paralyzed can be made to contract, thereby allowing more of the body to be exercised. The full rowing stroke is produced by both the (stimulated) legs and arms, increasing the active muscle mass and resulting in an aerobic work-out that is intensive enough to improve heart, lung, and - maybe - brain function. In this clinical trial of sub-acute spinal cord injured subjects, the investigators will study how 12 weeks of FES-RT, in comparisons to 12 weeks of wait-list, changes pain, brain structure, endogenous opioid function and brain inflammation. The investigators will measure changes using positron emission tomography and magnetic resonance imaging. The investigators hypothesize a decrease in pain interference, an increase in hippocampal volume, increased endogenous opioid transmission in the periaqueductal gray, and decreased hippocampus neuroinflammation.