Injecting Botulinum Toxin A Underneath the Skin to Treat Spinal Cord Pain in Patients With Spinal...
Neuropathic Back PainSpinal Cord InjuryBack pain is a common secondary condition of both acute and chronic spinal cord injury (SCI). Current existing treatment including both pharmacologic and non-pharmacologic are limited by marginal efficacy or intolerable side effects. The purpose of this study is to evaluate the potential of subcutaneous injections of botulinum toxin A to provide pain relief in spinal cord injury patients with back pain near the level of injury in the spine. Botulinum toxin A has been shown in both pre-clinical and clinical studies to help with nerve pain. The researchers propose a double blinded placebo controlled crossover study to study the effects of subcutaneous botulinum injections to at--level SCI back pain in patients with spinal cord injury.
Botox-A Injection to Improve Bladder Function in Early Spinal Cord Injury (#H-20344)
Neurogenic Bladder Dysfunction NosSpinal Cord InjuryThe purpose of this study is to see what the effect of Botox has on bladder function for those who have recently suffered spinal cord injury. We also will study bladder tissue levels of NGF (nerve growth factor) that can tell us how the nerves to the bladder are healing after injury. Consenting male and female cervical and high thoracic (T10 and above) SCI patients will be identified within the first 6-7 weeks after SCI and randomized to two external urethral sphincter injection groups. Each group will be injected within 8 weeks after SCI (Day 0) and 3 months later (Day 90). The injection paradigm will consist of: Group 1-100 units of BTX-A (Botox®, Allergan Inc., Irvine, CA) on Day 0 and 100 units of BTX-A on Day 90; Group 2-sham saline injections on both Day 0 and Day 90. Injections will be performed under local anesthesia using standard flexible cystoscopic equipment. Use of placebo is justified because: 1. there have been documentation of nerve desensitization with dry needling (i.e. acupuncture) and wet needling (i.e. saline)--therefore, to truly demonstrate benefit of Botox over just the needle insertion into the sphincter muscle or injection of the diluent saline, a sham saline injection group is included, 2. the injection procedure itself is minimally invasive and not expected to result in any complications. Subjects who qualify and have signed the informed consent document will be randomized into two groups, those receiving the BTX-A and those receiving placebo. Blinding will be performed by the TIRR pharmacy department who will provide Botox and placebo in identical syringes so that the treating staff will be blinded. Pharmacists will ensure patients receive the same agent at the time of the second injection. Unblinding will occur at the end of the study or if complications necessitate breaking of the code. Both groups will undergo urodynamic testing to document before and after treatment data. Bladder biopsies will be taken prior to treatment in both groups that will be analyzed for nerve growth factor. Three day voiding diaries will be kept and reviewed with the study coordinator at the follow up visits. Quality of life questionnaires will be completed at each follow up visit. The treatments will take place on Day 0 and Day 90. Follow up visits will occur at Day 120, 16 month, and 28 months.
Evaluation of Tolerability and Efficacy of Erythropoietin (EPO) Treatment in Spinal Shock: Comparative...
Spinal Cord InjuryThe purpose of this study is to evaluate the tolerability and efficacy of erythropoietin (EPO) treatment in spinal shock in comparison with the methylprednisolone treatment (MP).
Improving Hand Recovery With Neuromodulation in Tetraplegia
Spinal Cord InjuriesTetraplegia3 moreThis study will examine a form of non-invasive brain stimulation applied with intensive therapy of the arm and hand. The goal of the study is to determine if arm and hand function can be improved in people with incomplete cervical spinal cord injury (neck spinal cord injury, tetraplegia). Participants will be assigned to receive either active or inactive non-invasive brain stimulation.
Dried Plum Supplementation as Treatment for Bone Loss Following Spinal Cord Injury
Spinal Cord InjuriesThe purpose of this pilot study is to explore whether dried plum (prunes) added to the diet is effective in reducing or reversing bone loss following spinal cord injury (SCI). The investigators will look for changes in bone mineral density as well as evidence in the blood of markers of bone activity. The first part of the study is to check whether participants with SCI can and will eat the required amount of dried plums (prunes) on a daily basis. The second part of the study is to follow participants over one year and look for changes in bone mass and blood markers.
Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation
Spinal Cord InjuriesThis 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.
Effects of Transvertebral Direct Current Stimulation in Humans
Spinal Cord InjuriesParaplegia and TetraplegiaThis study will evaluate the effects of non-invasive stimulation of the spinal cord in people with spinal cord injury.
Safety Study of Outdoor and Indoor Mobility in People With Spinal Cord Injury (ROBOtics Spinal Cord...
Spinal Cord InjuryThe aim of this study will be to evaluate the safety and the efficacy of a new robotic exoskeleton device in subjects with Spinal Cord Injury (SCI) and in subjects with other neurological disease with an impairment of lower limbs.
Aquatic vs. Land Locomotor Training Overground Locomotor Training in Improving Ambulatory Function...
Spinal Cord InjuryThe aim of this study is to define and evaluate the efficacy of Aquatic Locomotor Training (ALT) compared to overground Locomotor Training in improving ambulatory function and health-related quality of life. The investigators hypothesize, that Aquatic Locomotor Training is capable of producing outcomes that are as good as, or better than, overground Locomotor Training. Aquatic Locomotor Training may be another tool for therapists to utilize for clinical improvements in function and gait for the Spinal Cord Injury (SCI) population. To determine the efficacy of Aquatic Locomotor Training on improving rehabilitation outcomes among patients with incomplete traumatic cervical Spinal Cord Injury by assessing these parameters: Walking speed and endurance Functional balance and fall risk HRQoL To describe the feasibility of conducting Aquatic Locomotor Training as an Locomotor Training modality for the rehabilitation of patients with incomplete traumatic cervical Spinal Cord Injury.
Spinal Cord Injury Neuroprotection With Glyburide
Acute Spinal Cord InjuryThe purpose of this study is to determine the safety of using oral Glyburide in patients with acute traumatic cervical spinal cord injuries (SCI).