View clinical trials related to Spinal Cord Injuries.
Filter by:Acute Spinal Cord Injury (SCI) is a rare injury that leads to permanent neuromotor impairment and sudden disability. Approximately 25,000 people experience cervical SCI in the United States, Europe, and Japan every year. The purpose of this study is to see if elezanumab is safe and assess change in Upper Extremity Motor Score (UEMS) in participants with acute traumatic cervical SCI. Elezanumab is an investigational drug being developed for the treatment of SCI. Elezanumab is a monoclonal antibody, that binds to an inhibitor of neuronal regeneration and neutralizes the inhibitor, thus potentially promoting neuroregeneration. This study is "double-blinded", which means that neither trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Participants 18-75 years of age with a SCI will be enrolled. Approximately 54 participants will be enrolled in the study in approximately 49 sites worldwide. Participants will receive intravenous (IV) doses of elezanumab or placebo within 24 hours of injury and every 4 weeks thereafter through Week 48 for a total of 13 doses. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
The purpose of this study is to examine the effectiveness of mobility training using the Ekso robotic exoskeleton with functional electrical stimulation (FES) in persons affected by spinal cord injury; designated AIS classification A, B, C, or D. Traditionally, a person with an American Spinal Injury Association Impairment Scale (AIS) "A" injury, walking training is not performed. Even with AIS B, C and D injuries, although walking training may be appropriate, a person may not walk as much as needed to see an improvement due to environmental and staff limitations. The Ekso is a tool to give walking training to patients. The investigators aim to see if utilizing these technologies will affect recovery; specifically in sensation and muscle activity below the level of the injury as well as the ability to walk. The Ekso is a wearable, battery- operated exoskeleton that assists with walking. The Ekso has motors at the hip and knee joints to provide assistance that may be needed with walking. All motion is initiated either through body weight shifts or the use of an external controller. The Ekso robotic exoskeleton has been approved by the Food and Drug Administration as a powered exercise device for rehabilitative purposes such as this study. Currently, the Ekso is approved for people with spinal cord injuries from T4-L5 given bilateral arm strength of 4/5. With injuries from C7-T3, individuals must have AIS classification of D with bilateral arm strength of 4/5. For this study, it is possible that Ekso GT will be used outside of the current FDA approval if the injury level is C7-T3 and the person is classified as an AIS A, B or C injury level. Functional electrical stimulation (FES) will be used in conjunction with the robotic exoskeleton. FES involves using surface electrodes placed on the skin like a sticker over key leg muscles that will be stimulated in the normal walking pattern as a person walks in the device.
Treatment for sublesional bone loss (osteoporosis) in persons with chronic, motor-complete spinal cord injury (SCI) has been limited and unsuccessful to date. Romosozumab, a sclerostin antagonist, has potential to increase bone formation (anabolic) and decrease bone resorption (anti-catabolic) in persons with chronic SCI. Conventional anti-resorptive therapy alone would not be anticipated to reverse sublesional bone loss in a timely manner because the skeleton below the level of lesion in chronic SCI is assumed to be in a low turnover state. However, because there is a high likelihood that the bone accrued while on romosozumab will be lost once discontinued, denosumab, an anti-resorptive agent, will be administered after treatment with romosozumab, to maintain or, possibly, to continue to increase, bone mineral density (BMD). The purpose of this study is to address the gap in the treatment of osteoporosis in individuals with chronic SCI by partially restoring BMD with romosozumab treatment for 12 months and then to maintain, or further increase, BMD with denosumab treatment for 12 months. A two group, randomized, double-blind, placebo-controlled clinical trial will be conducted in 39 participants who have chronic (>3 years), motor-complete or incomplete SCI and areal BMD (aBMD) values at the distal femur of at the distal femur <1.0 g/cm2 measured by dual photon X-ray absorptiometry (DXA). The intervention group will receive 12 months of romosozumab followed by 12 months of denosumab, and the control group will receive 12 months of placebo followed by 12 months denosumab.
Over 85,000 Canadians live with a spinal cord injury (SCI). The vast majority experience chronic pain from neuropathic or musculoskeletal origins, with many reporting the pain to be more physically, psychologically and socially debilitating than the injury itself. Currently, pharmaceuticals are the front line treatment recommendation for SCI pain, despite having many side-effects and giving minimal relief. Alternatively, studies conducted in controlled lab and clinical settings suggest that exercise may be a safe, effective behavioural strategy for reducing SCI-related chronic pain. Two ways in which exercise may alleviate pain are by reducing inflammation and increasing descending inhibitory control. To date, no study has tested the effects of exercise, performed in a home-/community-setting, on chronic pain in adults with SCI. Furthermore, information on the exercise dose required to alleviate chronic SCI pain is virtually non-existent, making it impossible for clinicians and fitness trainers to make evidence- informed recommendations regarding the types and amounts of exercise to perform in order to manage SCI pain. Recently (2018), an international team published two scientific SCI exercise guidelines: one to improve fitness and one to improve cardiometabolic health. These scientific guidelines have been translated into Canadian community SCI exercise guidelines and provide the exercise prescription for the proposed study. The investigators' overarching research question is: can home-/community-based exercise-prescribed according to these new SCI exercise guidelines and supported through a theory-based behavioural intervention- significantly reduce chronic pain in adults with SCI?
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.
This study will determine the level of functional gain, below the injury for voluntary control of movements, and recovery standing and stepping function as a result of activation of spinal circuits with scES in humans with severe paralysis. Training will consist of practicing stepping, standing and voluntary movements in the presence of specific scES configurations designed specific for stepping (Step-scES), specific for standing (Stand-scES) and for the voluntary movements of the legs and trunk (Vol-scES). Ability to step, stand, move voluntarily, as well as cardiovascular, respiratory, bladder, bowel and sexual function will be assessed in these individuals with chronic severe spinal cord injury.
It is an interventional study that aims to assess a new primary care model of collaboration between specialized centers and primary care physicians in Switzerland, in order to reduce morbidity and improve patients' and providers' experience with delivery of follow-up care in individuals with chronic spinal cord injury as compared to current best practice.
A group of 6 able-bodied healthy volunteers will receive Neostigmine (NEO) and Glycopyrrolate (GLY) intravenously and via 2 methods of Iontophoresis (ION): one-patch and two-patch administration, with subsequent blood draws over 1 hour in order to measure the pharmacokinetic behavior of the drugs in-vivo.
Incomplete cervical spinal cord injury (SCI) makes up half of all the newly admitted patients. For these individuals, the use of their upper limbs is critical for managing daily activities and self-care and impacts their quality of life. For home-based monitored rehabilitation, also called telerehabilitation, there are various rehabilitation equipment that are used. No studies have systematically gathered information regarding the perceptions of individuals with SCI regarding these equipment, training, and feasibility within the home. Further, their perceptions of the usability of high vs low end equipment is also not explored. In this study, investigators plan to gather survey and interview data from individuals with SCI regarding their experience with using rehabilitation equipment that uses games, muscle stimulation, and object manipulation. This study will inform the development of a tele-rehabilitation intervention in the future.
Paralysis of trunk muscles and the inability to sit upright is one of the major problems facing adults and children with spinal cord injury (SCI). Activity-based locomotor training has resulted in improved trunk control in children with spinal cord injury, though full recovery is not achieved in all children. Transcutaneous spinal stimulation' (TcStim), a stimulation applied over the skin to the sensory nerves and spinal cord, is a promising tool that may further enhance improvements to trunk control. The purpose of this study is to determine the feasibility (can we do it) and safety of Transcutaneous Stimulation (TcStim) in children with SCI to acutely improve sitting upright and when used with activity-based locomotor training (AB-LT). Thus, can we provide this therapy to children and do so safely examining a child's immediate response and cumulative response relative to safety and comfort. Eight participants in this study will sit as best they can with and without the stimulation (i.e. stimulation applied across the skin to the nerves entering the spinal cord and to the spinal cord) and their immediate response (safety, comfort, trunk position) recorded. Then, two participants will receive approximately 40 sessions of activity-based locomotor training in combination with the stimulation. Their cumulative response of stimulation (i.e. safety, comfort, feasibility) across time will be documented. Participation in this study may last up to 3 days for the 8 participants being observed for acute response to stimulation and up to 9 weeks for the participants being observed for cumulative response to training with stimulation. We will monitor the participants throughout the testing and training for their response to the stimulation (i.e. safety) and their comfort.