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Spinal Cord Injury clinical trials

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NCT ID: NCT02139436 Completed - Spinal Cord Injury Clinical Trials

Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI

Start date: December 2013
Phase: N/A
Study type: Interventional

Each year, 11,000 people suffer a spinal cord injury (SCI) in the U.S. Within the first year, there are profound declines in physiologic function, forming the underlying substrate for future cardiovascular disease . In fact, acquired cardiovascular disease is an increasingly recognized consequence of SCI and is the leading cause of death in SCI. Though incompletely understood, the almost 10-fold prevalence of cardiovascular disease results in part from profound physiologic 'detraining' resulting from motor impairment and immobility. Currently, effective interventions preventing acute declines that lead to cardiovascular compromise and increased risk in SCI are lacking - exercise therapy for those with SCI is challenging and when employed, is typically limited to the upper body. Recently, the investigators refined a unique form of exercise for those with SCI that specifically mirrors exercise performed by those without SCI. Functional Electrical Stimulation (FES) Row Training (RT) couples volitional arm and electrically controlled leg exercise, resulting in a hemodynamic profile that produces the beneficial cardiac loading conditions of large muscle mass exercise. As such, FES-RT may be a safe and effective way to attenuate cardiovascular declines following SCI. The investigators aims are to test the overall hypotheses that FES-RT will: 1) mitigate against increased visceral adiposity and reduced insulin sensitivity, 2) prevent worsening lipid profile and compromised baroreflex function, and 3) counter ventricular wall thickening and declining ventricular function occurring with acute SCI, and that these effects will be greater than that observed with an arms-only exercise group. Changes with FES-RT will be compared to a time (wait-list) control and to arms-only-RT. Individuals with an SCI within the last 3-6 months will be randomized to FES-RT, to a time control, or arms-only-RT. Measures will be made at baseline and 6 months. The investigators work will provide results that clearly delineate potential health benefits of FES-RT, and if FES-RT is effective in a majority of those with SCI, its application, implementation, and integration could be easily replicated.

NCT ID: NCT02138201 Completed - Spinal Cord Injury Clinical Trials

Representation of the Bladder Innervation Using Diffusion Tensor Imaging Fiber Tracking With MRI - a Pilot Study

Start date: January 2014
Phase: N/A
Study type: Observational

The exact innervation of the bladder and the changes after a spinal cord injury have been not yet been illustrated. Diffusion tensor imaging with magnetic resonance imaging is a new technique which can be used to visualize single nerve fibers, and thus represent the neural supply of a region in vivo. There are studies in which both the sacral plexus and the lumbar nerve roots have been represented using diffusion tensor imaging. However, there is no study concerning the innervation of the bladder. The investigators are therefore using diffusion tensor imaging with magnetic resonance imaging to represent the bladder innervation of individuals with neurogenic lower urinary tract dysfunction and individuals with normal bladder function.

NCT ID: NCT02138149 Completed - Spinal Cord Injury Clinical Trials

Is the Nerve Growth Factor (NGF) a Useful Biomarker in Neurogenic Bladder Dysfunction After Spinal Cord Injury?

Start date: November 2013
Phase: N/A
Study type: Observational

Spinal cord injury (SCI) almost always affects bladder function as well. As a result of this bladder dysfunction, individuals with SCI have to undergo regular invasive examination of their bladder function (urodynamic examination). The nerve growth factor (NGF) is released from smooth muscle cells of the bladder, and there are reports, that the concentration of NGF is elevated in the urine of patients with bladder dysfunction. The NGF concentration can also be measured in the blood. The concentration of NGF in the blood and urine of SCI individuals has not yet been investigated. These concentrations may correlate with the severity of bladder dysfunction, and may thus be used to replace or at least reduce the number of the more invasive urodynamic examinations. The hypothesis that urine and blood NGF concentrations in individuals with SCI are higher compared to individuals with healthy bladder function will be tested.

NCT ID: NCT02135978 Completed - Spinal Cord Injury Clinical Trials

Maintenance of Shoulder Health and Function After Spinal Cord Injury

Start date: April 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if a shoulder exercise program can prevent the onset of shoulder pain and improve community participation in persons who have a spinal cord injury (SCI). Upon entry into the study patients will have pain-free shoulders and will be followed for 3 years to determine rate of shoulder pain development. Patients will learn a simple shoulder home exercise program and will be instructed on techniques to protect their shoulder during wheelchair propulsion, transfers and activities of daily living. Patients will be instructed to perform the home exercise program 3 days per week. Two types of treatment (training) delivery approaches that have been documented to reduce chronic shoulder pain will be compared. The rate of shoulder pain development for the two groups will be compared to the rate of shoulder pain development in the historical control group. The investigators hypothesize that the rate of shoulder pain development will be lower in the experimental treatment groups compared to the historical control group. Any differences between the two treatment delivery approaches for the experimental treatment groups will help to provide guidelines for the most effective delivery approach of a shoulder pain prevention program.

NCT ID: NCT02132702 Completed - Spinal Cord Injury Clinical Trials

Performance Attributes and User Progression While Using Ekso

Start date: August 2014
Phase: N/A
Study type: Interventional

This study is to evaluate the performance attributes and user progression of participants with motor complete and incomplete spinal cord injury (SCI) while utilizing the Ekso robotic exoskeleton in an eight week over ground, locomotor program. We hypothesize an improvement in progression and overall health while using Ekso.

NCT ID: NCT02127606 Recruiting - Spinal Cord Injury Clinical Trials

The Effect of Whole Body Vibration on Spasticity in Persons With Spinal Cord Injury

Start date: April 2014
Phase: N/A
Study type: Interventional

Extended periods of tilt table standing have been observed to improve spasticity in individuals with spinal cord injury (SCI). The purpose of this study is to determine the effect of three sessions of whole body vibration while tilt table standing on spasticity in individuals with a complete or incomplete SCI above the neurological level of T10. Participants in this study will undergo whole body vibration while standing on a tilt table for a total of approximately 14 minutes for a total of 3 sessions on 3 separate days. Spasticity monitoring will be evaluated prior to and after the intervention with the Modified Penn Spasm Frequency Scale, an interview to obtain the individual's perception and impression of the effect of whole body vibration on the performance of activities of daily living, quality of life, pain scale, and global impression of change.

NCT ID: NCT02122991 Completed - Spinal Cord Injury Clinical Trials

Cardiovascular, Cerebrovascular, and Cognitive Function in Spinal Cord Injury

Start date: July 2013
Phase: N/A
Study type: Observational

Increased life expectancy in individuals with spinal cord injury (SCI) present clinicians with the challenge of managing the secondary complications of SCI with the chronic diseases common in an aging population. Cardiovascular disease, cerebral vascular disease, and cognitive dysfunction are among the primary challenges facing clinicians in the treatment of an aging population. Cognitive dysfunction has been reported in upwards of 60% of the SCI population, which have been primarily attributed to concomitant traumatic brain injury or pre-morbid conditions. Identifying possible modifiable risk factors which contribute to the increased prevalence of cognitive dysfunction in the SCI population is of significant clinical relevance and cardiovascular and cerebrovascular disorders have emerged as possible contributors to the cognitive disorders in the general population. These risk factors include: physical inactivity, chronically low or high blood pressure (BP), reduced blood flow to the brain, arterial stiffening, and impaired nervous system regulation of the cardiovascular system. These risk factors are particularly prominent in the SCI population as they represent a model of profound inactivity, have trouble regulating blood pressure, and suffer impaired cardiovascular regulation from their injury. In addition, we've recently reported deficits in blood flow to the brain at rest and during cognitive tests; with results being further impaired in SCI with chronically low blood pressure. Therefore the goals of this project are to determine the influence of cardiovascular and cerebral vascular responses at rest and during cognitive testing on test performance in 80 individuals with SCI compared to 50 age-matched non-SCI controls. All potential subjects will undergo a rigorous two-part screening process which consists of an initial screening via telephone and a detailed, in-person screening. Eligible subjects will be invited to participate in a 3 hour laboratory visit during which their arterial stiffness, blood pressure, heart rate, respiration rate and, blood flow to the brain will be monitored at rest and during a comprehensive series of cognitive tests. We hypothesize that blood pressure and cerebrovascular response to testing will account significantly for performance in cognitive testing that otherwise would have been attributable to SCI status.

NCT ID: NCT02118740 Recruiting - Spinal Cord Injury Clinical Trials

Bone Marrow Collection in Healthy Volunteers (iCell)

iCell
Start date: June 2015
Phase: N/A
Study type: Observational [Patient Registry]

This is a observational study in which healthy found volunteers are recruited to donate 50 ml of bone marrow aspirate to enable preclinical studies to obtain proof of concept and safety of a bone marrow derived stem cell preparation named AMARCELL. The prepared AMARCELL is only for animal studies and after completion of the preclinical program, the intention of AMARCELL is to treat humans with a traumatic Spinal cord injury.

NCT ID: NCT02118194 Active, not recruiting - Spinal Cord Injury Clinical Trials

Home/Work, Community Mobility Skills in the ReWalk Exoskeleton in Persons With SCI

VA_ReWalk2
Start date: October 2013
Phase:
Study type: Observational

The overall goal of this project is to determine if non-ambulatory persons with spinal cord injury (SCI) who have already participated in at least 20 sessions of ReWalk training can be further trained to achieve more advanced skills for use in the home or work place environments and outdoor community mobility skills in the ReWalk exoskeleton.

NCT ID: NCT02115685 Completed - Spinal Cord Injury Clinical Trials

Sympathetic-Somatomotor Coupling in Human Spinal Cord Injury

Start date: April 2014
Phase: N/A
Study type: Interventional

Significance: The long term objective of this study is to improve physical therapy and fitness programs in people with spinal cord injury. The results of the study will demonstrate the importance of matching blood flow to a muscle with exercise of that same muscle. Scientific Objective: The objective of the study is to measure how the body regulates bloodflow to a muscle during exercise. We intend to study these effects by triggering blood flow changes during movement, and measuring bloodflow changes during exercise in people with spinal cord injury. We will also look at the long term effects of different exercise programs on bloodflow during exercise. Study Populations: This study will involve people with partial spinal cord injury and age and sex matched controls without injury. Specific Aims: Aim 1 will be to measure bloodflow during exercise of the legs (below the injury). This aim will examine the control of bloodflow and muscle contractions and how it changes after spinal cord injury. Aim 2 will then look at changes in bloodflow during exercise after training. Three different eight week exercise training programs will be tested including 1) upper body ergometry, 2) treadmill training with exertion level matched to the upper body ergometry and 3) treadmill training with heart rate matched to an initial test of upper body ergometry.