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Spinal Cord Injury clinical trials

View clinical trials related to Spinal Cord Injury.

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NCT ID: NCT02586649 Completed - Spinal Cord Injury Clinical Trials

24hr Effects of Tiotropium Bromide in Tetraplegia

Start date: July 2014
Phase: Phase 2
Study type: Interventional

Respiratory complications are the leading cause of death during the initial year after acute SCI, and the third leading cause of death thereafter. Complete or partial loss of respiratory muscle innervations in individuals with cervical and high thoracic injuries leads to inadequate ventilation and inability to effectively clear secretions, often prompting supportive ventilation following initial injury. Development of atelactasis, pneumonias and respiratory failure are the most common respiratory complications observed during the acute phase of injury. It is well known that a restrictive ventilatory defect, dependent upon the level and completeness of injury, is apparent in individuals with chronic cervical SCI. Respiratory functional impairment might be further compromised in these individuals, the majority of whom share many aspects of obstructive airway physiology commonly associated with asthma. The asthma-like features that individuals with chronic cervical SCI demonstrate have been hypothesized to be due to overriding cholinergic airway tone carried by intact vagal (parasympathetic) nerve fibers arising from the brainstem, whereas sympathetic innervations is interrupted at the level of the upper thoracic spinal cord. Whether airway narrowing and AHR in chronic cervical SCI is also related to chronic airway inflammation is unknown, although it is conceivable that repeated respiratory infections or, possibly, a neurogenic component, could contribute to chronic airway inflammation. Therefore, the investigators aim to assess how long-acting bronchodilator (tiotropium bromide) affects various indices of lung function, including: pulmonary function tests, levels of inflammation and cough strength across 24 hours after receiving study drug. Results will be analyzed for baseline, 1 hour, 3 hours, 20 hours and 24 hours post drug inhalation for both active medication and non-active placebo.

NCT ID: NCT02585765 Withdrawn - Spinal Cord Injury Clinical Trials

Skin Blood Flow Response to Insulin Iontophoresis in Pressure Ulcers of SCI

Start date: February 1, 2017
Phase: Phase 2
Study type: Interventional

Pressure ulcers (PU) are skin breakdowns that often form after blood flow in the skin is reduced from prolonged and repeated exposure to externally applied forces. As many as 85% of individuals with a spinal cord injury (SCI) report the occurrence of at least 1 PU since being injured. Despite the increasing attention and emphasis on prevention, PUs still represent a major health risk for persons with SCI. Among the numerous potential physical risk factors identified for the development of a PU were several conditions that have a significant negative effect on skin blood flow. In addition, improper management of blood sugar is a major risk factor for PU development and it impedes healing. It would appear that hormones (i.e., chemical signals in the blood) associated with how the body uses sugar that target the blood vessels may play an important role in the development and formation of a PU. In persons with SCI, skin blood flow responses to insulin (i.e., a hormone that helps the body use sugar and also relaxes the blood vessels allowing blood flow to increase) in the lower extremity were shown to be much lower than healthy individuals. The proposed study in up to 30 individuals with chronic SCI and a difficult-to-heal pelvic region PU has 2 phases: (1) a 4-week "observation" phase [if the PU does not heal appropriately (determined by digital photos and software computation), and the subject is found to be insulin resistant then they will progress to the next phase of the study] and (2) an 8-week "treatment" phase. All participants will continue to receive the standard wound care throughout the observation and treatment phases. If the surface area of the PU does not decrease by more than 30% during the 4-week observation phase, the participant will be eligible to enter the 8-week treatment phase, in which they will be randomly assigned to receive active drug (e.g., pioglitazone) or placebo. The participants will have four study visits in which the following will be acquired: digital image of the wound to monitor wound surface area, skin blood flow measurements of the peri-wound area, and blood tests to monitor liver function, kidney function, blood sugar (hemoglobin A1C, insulin, glucose), nutritional status (albumin and pre-albumin), a complete blood count with differential, and makers of inflammation. Weekly monitoring of symptoms and participant experiences will be closely monitored.

NCT ID: NCT02584426 Completed - Spinal Cord Injury Clinical Trials

Subcutaneous Injection and Ultrasonic Dispersion of Cefazolin Into Chronic Pelvic-Region Pressure Ulcers in Persons With Spinal Cord Injury

Start date: January 2017
Phase: N/A
Study type: Interventional

Pressure ulcers (PU) are skin breakdowns that often form after blood flow in the skin is reduced from prolonged and repeated exposure to externally applied forces. As many as 85% of individuals with a spinal cord injury (SCI) report the occurrence of at least 1 PU since being injured. Despite the increasing attention and emphasis on prevention, PUs still represent a major health risk for persons with SCI. PUs and other skin breakdowns are at risk for becoming infected; it is not uncommon for many different types of "bugs" to be found in the wound. It has been assumed that the presence of these organisms did not impede wound healing or skin graft survival. The current proposal will use a new type of procedure that involves the direct injection of an antibiotic (in saline) into the skin beneath the wound; it is then distributed throughout the wound using a second device that uses sound waves. The study will determine if the antibiotic treatment and the standard of care improves the rate wound closure compared to the standard of care alone in persons with SCI and a chronic pelvic-region PU.

NCT ID: NCT02582619 Completed - Spinal Cord Injury Clinical Trials

Multidisciplinary Model to Guide Employment Amongst PLWSCI

Start date: October 2015
Phase:
Study type: Observational

Spinal cord injury often results in complete or partial loss of functioning of the upper and or lower limbs, leading to the affected individual experiencing difficulties in performing activities of daily living. This in turn results in reduced participation in social, religious, recreational and economic activities (employment). Globally, there is a low employment rate (11-67%) amongst PLWSCI. In South Africa, according to Statistics South Africa, the unemployment rate of people with disabilities is estimated to be 25.2%. However, there is no information available on employment amongst PLWSCI in South Africa. Furthermore, there is insufficient knowledge related to SCI in South Africa to enable a model to be developed and implemented. Data on the current SCI rehabilitation practices (with specific reference to vocational rehabilitation); employment status and factors (both personal and environmental); barriers and facilitators of employment amongst PLWSCI is limited. This information is needed to develop a return to work model for individuals with SCI in South Africa. In South Africa, a legal framework exists that promotes the employment as well as assistance of people with disabilities in the workplace, such as: the Constitution of Republic of South Africa, 1996; the Employment Equity Act (EEA), 1998; the Promotion of Equality and Prevention of Unfair Discrimination Act (PEPUDA), 2000; Labour Relations Act (LRA), 1995; Skills Development Act (SDA), 1998; Public Service Act (PSA), 1994; Basic Conditions of Employment Act (BCEA), 1997 and the Integrated National Disability Strategy (2000). However, rehabilitation interventions provided in rehabilitation institutions are mainly medical, with limited attempts to prepare those with SCI to return to gainful employment. There is therefore a need for a well-coordinated, multi-sectorial, multi-disciplinary and multi-factorial rehabilitation intervention that will promote the employment of PLWSCI in South Africa.

NCT ID: NCT02574585 Not yet recruiting - Spinal Cord Injury Clinical Trials

Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury Spinal Cord Injury

Start date: December 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to analyze the safety and efficacy of autologous bone marrow mesenchymal stem cell transplantation in patients with thoracolumbar chronic and complete spinal cord injury.

NCT ID: NCT02574572 Recruiting - Spinal Cord Injury Clinical Trials

Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury

Start date: September 6, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to analyze the safety and efficacy of autologous bone marrow mesenchymal stem cell transplantation in patients with cervical chronic and complete spinal cord injury.

NCT ID: NCT02573402 Completed - Spinal Cord Injury Clinical Trials

The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury

Start date: July 12, 2016
Phase: N/A
Study type: Interventional

The purpose of this research study is to evaluate the effects upon the bladder of electric stimulation of the leg's tibial nerve in people with acute spinal cord injury with an intervention called transcutaneous tibial nerve stimulation (TTNS).

NCT ID: NCT02570932 Completed - Spinal Cord Injury Clinical Trials

Administration of Expanded Autologous Adult Bone Marrow Mesenchymal Cells in Established Chronic Spinal Cord Injuries

Start date: July 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to analyze the potential clinical efficacy of intrathecal administration, in the subarachnoid space, of in vitro expanded autologous adult bone marrow mesenchymal stem cells in the treatment of patients with established chronic spinal cord injury (LEM).

NCT ID: NCT02564419 Completed - Spinal Cord Injury Clinical Trials

Brain Machine Interface (BMI) in Subjects Living With Quadriplegia

BMI
Start date: November 2015
Phase: N/A
Study type: Interventional

In this study, investigators will show proof-of-concept that brain signals can be used in real-time, closed-loop mode to trigger stimulation for hand function. Subjects will undergo surgery to implant a unilateral subdural strip electrode (Resume II, Model 3587A) over the motor cortex. These electrodes implanted in the brain will enable bioelectrical data recording (sensing) from the brain to the implanted Activa PC+S. The cortical sensing data will be 1. either processed in the Activa PC+S; or 2. off-loaded via the Nexus D communication device (Medtronic) to a computer.

NCT ID: NCT02560506 Completed - Spinal Cord Injury Clinical Trials

Development of Low Cost Devices to Increase Access to Treadmill Training

Start date: January 2008
Phase: N/A
Study type: Interventional

The goals of this Model System Program are to expand upon and advance the findings and outcomes of previous and current Model Systems clinical research, to continue to develop and study the effectiveness of innovative treatment strategies for persons with spinal cord injury (SCI); and to evaluate the benefits of a well-designed, comprehensive, coordinated, interdisciplinary continuum of care that lead to improved outcomes for all persons with SCI. In order to achieve these goals, the following objectives of the Midwest Regional Spinal Cord Injury Care System (MRSCICS) model system grant proposal will be accomplished.