Spinal Cord Injuries Clinical Trials

The goal of this study is to determine whether administration of sildenafil will decrease urine leakage in patients with spinal cord injuries. Read Less

This randomized controlled trial aims to assess effects of videoconferencing acceptance and commitment therapy (ACT) on mental health outcomes in individuals living with spinal cord injuries (SCI). A total of 40 individuals living with SCI sustained within 5 years and experiencing depressive symptoms will be recruited and randomly assigned to either the ACT group or the wait-list control group. The ACT group will receive 8 weekly individual ACT sessions guided by a coach through videoconferencing. The wait-list group will receive ACT sessions after the study period ends. We will provide psychoeducation materials related to SCI as supplemental resources to both groups. Mental health outcomes using self-reported questionnaires will be collected at pretest, posttest, and 2-month follow-up. Exploratory hypotheses are that the group undergoing the ACT intervention supplemented with psychoeducation will show improvements in mental health outcomes (e.g., depression) and ACT processes (e.g., psychological flexibility) at posttest and 2-month follow-up, compared to the wait-list control group provided with psychoeducation materials alone. Interviews will be conducted at posttest to explore the participants' experiences in ACT. Read Less

The goal of this study is to identify the effect of different types of noninvasive spinal stimulation on spasticity (involuntary muscle activity), muscle strength, and pain in people with spinal cord injury. The spinal stimulation consists of electrical stimulation applied through one electrode over the skin of the lower back and two electrodes over the stomach. Testing will include participating in measurements before the intervention, during intervention, and immediately after the intervention. This study requires participants to come into Shepherd Center 4 consecutive days a week for 2-3 hours per day across 2-3 weeks. Read Less

Chronic neuropathic pain is defined as pain caused by a lesion or disease of the somatosensory nervous system. It is highly prevalent, debilitating, and challenging to treat. Current available treatments have low efficacy, high side effect burden, and are prone to misuse and dependence. Emerging evidence suggests that the transition from acute to chronic neuropathic pain is associated with reorganization of central brain circuits involved in pain processing. Repetitive transcranial magnetic stimulation (rTMS) is a promising alternative treatment that uses focused magnetic pulses to non-invasively modulate brain activity, a strategy that can potentially circumvent the adverse effects of available treatments for pain. RTMS is FDA-approved for the treatment of major depressive disorder, obsessive-compulsive disorder, and migraine, and has been shown to reduce pain scores when applied to the contralateral motor cortex (M1). However, available studies of rTMS for chronic neuropathic pain typically show variable and often short-lived benefits, and many aspects of optimal treatment remain unknown, including ideal rTMS stimulation parameters, duration of treatment, and relationship to the underlying pain etiology. Here the investigators propose to evaluate the efficacy of high frequency rTMS to M1, the region with most evidence of benefit in chronic neuropathic pain, and to use functional magnetic resonance imaging (fMRI) to identify alternative rTMS targets for participants that do not respond to stimulation at M1. The central aim is to evaluate the pain relieving efficacy of multi-session high-frequency M1 TMS for pain. In secondary exploratory analyses, the investigator propose to investigate patient characteristic that are predictive of responsive to M1 rTMS and identify viable alternative stimulation targets in non-responders to M1 rTMS. Read Less

This is a phase 1 study of safety and feasibility of cervical spinal cord stimulator implantation in cervical SCI subjects who are ventilator dependent. The Investigators will be focusing on the safety and feasibility of this approach. Participants may qualify for the study if they are male or female 18-75 years old, are at least 1 year after original injury, have injury at C2 to C7 level, and dependent on mechanical ventilation to help them breathe. Additionally, they need to be able to attend up to twice weekly testing sessions for up to 21 months. Read Less

The main goal of the project is to develop multiple noninvasive neuromodulatory strategies to facilitate full weight bearing stepping overground in people with paralysis. We will determine the effectiveness of combining noninvasive spinal cord stimulation and the administration of buspirone (a monoaminergic agonist) in facilitating locomotor activity in a gravity-neutral apparatus, during body weight supported stepping on a treadmill, when stepping overground in an assistive robotic exoskeleton, or during full weight bearing stepping overground in a rolling walker. Our objective is to identify the experimental variables that define the efficacy of these novel neuromodulatory techniques over a 5 year period in 15 participants with severe spinal cord injury who are at least one year post-injury. Read Less

Respiratory motor control deficit is the leading cause of morbidity and mortality in patients with spinal cord injury. The long-term goal of this NIH-funded study is to develop a rehabilitation strategy for respiration in patients with spinal cord injury as a standard of care. Respiratory function in patients with chronic spinal cord injury can be improved by using inspiratory-expiratory pressure threshold respiratory training protocol. However, the effectiveness of this intervention is limited by the levels of functional capacity preserved below the neurological level of injury. Preliminary data obtained for this study demonstrate that electrical spinal cord stimulation applied epidurally at the lumbar level in combination with respiratory training can activate and re-organize spinal motor networks for respiration. This study is designed to investigate respiratory motor control-related responses to epidural spinal cord stimulation alone and in combination with respiratory training. By characterization of respiratory muscle activation patterns using surface electromyography in association with pulmonary functional and respiration-related cardiovascular measures, the investigators expect to determine the specific stimulation parameters needed to increase spinal excitability below level of injury to enhance responses to the input from supraspinal centers that remain after injury and to promote the neural plasticity driven by the respiratory training. This hypothesis will be tested by pursuing two Specific Aims: 1) Evaluate the acute effects of epidural spinal cord stimulation on respiratory functional and motor control properties; and 2) Evaluate the effectiveness of epidural spinal cord stimulation combined with respiratory training. Read Less

The goal of this study is to assess the function of the lungs and the muscles are used to breathe after individuals receive respiratory training, spinal cord stimulation, a combination of respiratory training and stimulation, a combination of arm training and stimulation, or a combination of trunk training and stimulation. The respiratory, arm, and trunk training combined with the spinal stimulation interventions are being used to activate the spinal cord below the level of injury. Investigators will be looking for changes in the function of the lungs and trunk muscles before, during, and after these task-specific and non-task-specific interventions for breathing to determine which one has the greatest effect. The results of this study may aid in the development of treatments to help individuals with spinal cord injuries that have impaired lung, arm, and trunk function. Read Less

Respiratory complications are among the leading causes of death in patients with chronic spinal cord injury (SCI). Our previous work showed that pulmonary function can be improved by using our original respiratory training method. However, the effectiveness of this intervention is limited due to the disruption of brain-spinal connections and consequently lowered spinal cord activity below the injury level. Our recent studies showed that electrical stimulation of the spinal cord below the level of injury leads to increased ventilation which indicates activation of the spinal cord structures related to respiration. These findings indicate that spinal cord stimulation can be a promising therapeutic additive to the treatment. The goal of this study is to justify the establishment of a new direction in rehabilitation for patients with SCI by using a non-invasive spinal cord stimulation in combination with respiratory training. Our aims are: 1) to evaluate the effects of such stimulation applied to the injured spinal cord on pulmonary function and respiratory muscle activity, and 2) to evaluate the effectiveness and therapeutic mechanisms of the spinal cord stimulation combined with respiratory training. Thirty-six individuals with chronic SCI will be recruited and assigned to three groups to receive respiratory training or spinal cord stimulation alone or a combination of them. All participants will be tested before and after cycles of experimental procedures with/or without stimulation. Our hypotheses will be confirmed if the respiratory training combined with spinal cord stimulation results in the most enhanced positive effects. Read Less

The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts. Read Less

Spinal cord injury (SCI) is a devastating health problem for tens of thousands of military personnel, Veterans and civilians annually. Many persons with SCI must use a wheelchair for their entire life. A new scientific breakthrough called "lumbosacral epidural stimulation" or "ES" can help people with SCI to stand, step and even walk again. At present, for ES to work, people must train with a specialized treadmill that requires several other qualified personnel to train them, which makes it hard for many people with SCI to benefit from this technology. On the other hand, there are wearable "robot suits" that can be used with ES, which would make it easier to use. Our research team has already used this "ES Robot Suit" for 3 months in one person with tetraplegia and showed remarkable improvements in motor control. Furthermore, the investigators are aiming to enhance overground motor recovery by adding 6 months of resistance training (RT). The addition of RT will likely to enhance muscle quality as indicated by increasing lean mass, peak torque and increase sensory flux to the central nervous system. Other additional benefits may include improvement in cardiovascular profile and bladder functions. The specific objectives of the current proposal are to compare the impact of EAW+ES following improving lower extremity muscle quality compared to those who will only undergo EAW+ ES without conducting RT on motor recovery, cardio-metabolic health and bladder control in persons with complete SCI. At the conclusion of the current proposal, the work will be readily available for translation into clinical setting to serve Veterans and Civilian survivors with SCI. Read Less

The heart and brain are regulated by the autonomic nervous system. Control of these organs can be disrupted in people with spinal cord injury (SCI). This may affect their ability to regulate blood pressure during daily activities and process the high-level information. Previous studies show that high-intensity exercise induces better outcomes on heart and information processing ability in non-injured people compared to moderate-intensity exercise. However, it is unknown the effects of high-intensity exercise on heart and brain function in people with SCI. Therefore, this study aims to examine the effects of a single bout of high-intensity interval training on heart and brain function in this people with SCI compared to age- and sex-matched non-injured controls. Read Less