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Spinal Cord Injuries clinical trials

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NCT ID: NCT02441179 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Acute Intermittent Hypoxia and Body Weight Supported Treadmill Training for Incomplete Spinal Cord Injury Patients

Start date: March 2015
Phase: N/A
Study type: Interventional

Spinal cord injury (SCI) interrupts descending synaptic pathways from brainstem premotor neurons to spinal motor neurons, thereby paralyzing muscles below the neurological level. In recent years, considerable evidence has demonstrated that acute intermittent hypoxia (AIH) elicits plasticity in the spinal cord and strengthens spare synaptic pathways which is expressed as respiratory and somatic functional recovery in animals and humans suffering from incomplete SCI. The fundamental hypothesis guiding this project is that AIH-induced motor plasticity can be "harnessed" to improve walking capacity in incomplete SCI patients, classified as C and D categories according to International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). The inclusion criteria include patients > 18 years-old, with traumatic or non-traumatic, non-progressive incomplete SCI, onset > 6 months, neurological level C5-T12, with walking ability with or without assistive devices, without joint contractures, orthopedic injuries, osteoporosis, cutaneous lesions, cardiopulmonary complications and a body weight below 150 Kg. A randomized, triple-blind, placebo-controlled parallel design study will be done including 100% of patients fulfilling the criteria. Participants will receive repetitive acute intermittent hypoxia (rAIH: 15 episodes of 90 second 9% inspired oxygen interspersed with 90-second normoxia) or repetitive continued normoxia (rSham: 21% inspired oxygen) combined with 45 minutes body weight-supported treadmill training on 5 consecutive days and then three times per week for 3 weeks. Primary outcome measurement will be the 10-meter walking test. Secondary outcome measurements include the 6-minute walking test, timed up and go test, body/weight load, modified ashworth scale and visual analog scale. All outcomes will be measured before beginning the protocol (baseline), after five days of AIH/Sham (D5), weekly up to the end of the study (W2-W4), and a post-study follow-up for 2 weeks (F1-F2). Aditionally, cognitive assesment before and after the study will be performed using the "Figura compleja de Rey-Osterrieth" and the "Test de aprendizaje verbal España Complutense (TAVEC)". Repetitive AIH and body weight-supported treadmill training may represent a novel, safe, and noninvasive potential therapy to partially restore walking function in incomplete sub-acute and chronic SCI patients, a population with limited, if any, potential for improved function.

NCT ID: NCT02357914 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Freehand Ultrasound to Evaluate Scapular Kinematics in People With Paraplegia

FUS
Start date: April 2015
Phase:
Study type: Observational

Shoulder pain is very common in people with spinal cord injury (SCI). Persons with high-level paraplegia have higher chances to suffer shoulder pain and injury than those with lower-level paraplegia due to the shoulder muscle imbalance. As people with SCI overuse the shoulder during routine daily activities, the onset of pain or injury lead to increased healthcare expenses, limitation in activity, depression, decreased participation, and reduced quality of life. One of the main reasons of shoulder pain is believed to have a altered scapular movement. To clarify the mechanism of the shoulder pain and injury, comprehensive understanding of three-dimensional scapular kinematics is required. Ultrasound is a low-cost and non-invasive imaging system and has been used to diagnose the shoulder pain and injury in individuals with SCI. A freehand ultrasound (FUS) combining ultrasound with motion capture system to evaluate scapular movement was developed and presented favorable results in able-bodied population. The purpose of this study is to compare the FUS and widely used skin-based method against a radiographic based gold standard in people with paraplegia, and to elucidate the relationship among scapular movement and shoulder pain, pathology. This study will also allow us to gain more understanding of how level of injury influences the scapular behavior during functional activities. The investigators believe more severe shoulder pain and pathology will be associated with greater abnormal scapular movement. The investigators also believe that people with high-level paraplegia will have greater scapular abnormality than people with low-level paraplegia during arm elevation and weight relief raise tasks. By completing this study, the investigators will expect to deliver a reliable and valid tool to evaluate scapular movement and gain a better understanding how the altered scapular movement is related to shoulder pain and pathology. The investigators will also learn how the level of injury affects the scapular behavior during functional activities. The results of this study may help the shoulder pain management leading to the improvement in the quality of life of individuals with SCI.

NCT ID: NCT02326662 Active, not recruiting - Spinal Cord Injury Clinical Trials

Neural Stem Cell Transplantation in Traumatic Spinal Cord Injury

Start date: July 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This research investigates the use of autologous neural stem cells in patients with complete traumatic spinal cord injury.

NCT ID: NCT02313194 Active, not recruiting - Tetraplegia Clinical Trials

Spinal Cord Neuromodulation for Spinal Cord Injury

Start date: July 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to assess the strategy of using spinal cord stimulation to improve the ability to move in spinal cord injured humans.

NCT ID: NCT02274116 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Acute Intermittent Hypoxia on Leg Function Following Spinal Cord Injury

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

The purpose of this study is to determine how the nervous system controlling leg muscles is altered following spinal cord injury and how they may be affected by brief periods of low oxygen inhalation over time. The investigators hypothesize: - Acute intermittent hypoxia (AIH) exposure will increase maximum voluntary leg strength in persons with incomplete cervical spinal cord injury (SCI) - AIH exposure will increase multijoint reflex excitability of leg muscles in persons with incomplete cervical SCI - AIH exposure will increase walking performance in persons with incomplete cervical SCI

NCT ID: NCT02136823 Active, not recruiting - Clinical trials for Chronic Spinal Cord Injury

Impact of Persistent Conductances on Motor Unit Firing in SCI

Start date: June 2009
Phase: N/A
Study type: Interventional

This study is being done to measure the differences between the electrical activity of muscles and /single muscle fibers in individuals with long-term spinal cord injury and neurologically intact individuals without spinal cord injury. This study is also being done to find out if muscle and /single muscle fiber electrical activity, voluntary strength, reflex measurements, and/or spasms are changed after a single, oral dose of three commonly prescribed drugs, Rilutek®, isradipine, and Namenda®. These medications are approved by the FDA for treatment of disorders other than the control of spasms and strength. In this study, they are being used in an experimental manner. Finally, this study is also being done to find out whether or not a brief stretching exercise influences reflex measurements. The main hypothesis of this study is that aberrant current activity in spinal motoneurons contributes to spastic hyper-reflexia following chronic 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: NCT02089880 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Comparing Functional Outcomes in Individuals Using Micro-processor Controlled Orthosis Versus Stance Control Orthosis

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

The study will specifically evaluate the potential of the C-Brace to improve the functional mobility and quality of life in individuals with lower extremity impairments due to neurologic or neuromuscular disease, orthopedic disease or trauma, as compared to the stance control orthosis.

NCT ID: NCT01788969 Active, not recruiting - Spinal Cord Injury Clinical Trials

Serotonergic Modulation of Motor Function in Subacute and Chronic SCI

Start date: June 2005
Phase: Phase 1
Study type: Interventional

The manifestation of weakness and involuntary reflexes following motor incomplete spinal cord injury (SCI) may be partly a result of damage to descending pathways to the spinal cord that release serotonin. In models of SCI, for example, application of agents that simulate serotonin has been shown to modulate voluntary motor behaviors, including augmentation of walking recovery. In humans following neurological injury, the effects of 5HT agents are unclear. Few previous reports indicate improved motor function following administration of agents which enhance the available serotonin in the brain, although some data suggests that decreased serotonin may be beneficial. In this application, the investigators propose to study the effects of clinically used agents that increase or decrease intrinsic serotonin activity in the brain on strength and walking ability following human motor incomplete SCI. Using detailed electrophysiological recordings, and biomechanical and behavioral measures, the investigators will determine the effects of acute or chronic doses of these drugs on voluntary and involuntary motor behaviors during static and dynamic conditions. The novelty of this proposed research is the expectation that agents that enhance serotonin activity may increase abnormal reflexes in SCI, but simultaneously facilitate motor and walking recovery. Despite potential improvements in voluntary function, the use of pharmacological agents that may enhance spastic motor behaviors following SCI is in marked contrast to the way in which drugs are typically used in the clinical setting.

NCT ID: NCT01753882 Active, not recruiting - Spinal Cord Injury Clinical Trials

Monoaminergic Modulation of Motor Function in Subacute Incomplete Spinal Cord Injury (SCI)

Start date: February 2012
Phase: Phase 1
Study type: Interventional

The primary goal of the proposed clinical trial is to investigate the combined effects of walking training and monoaminergic agents (SSRIs and TIZ) on motor function of individuals in sub-acute (2-7 mo) human motor incomplete Spinal Cord Injury (SCI), with a primary emphasis on improvement in locomotor capability. We hypothesize that the use of these drugs applied early following SCI may facilitate independent stepping ability, and its combination with intensive stepping training will result in improved locomotor recovery following incomplete SCI. Loss of descending control via norepinephrine inputs following spinal cord injury can impair normal sensorimotor function through depressing motor excitability and impairing walking capacity. Replacing these inputs with drugs can alter the excitability and assist with reorganization of locomotor circuits. Assessment of single-dose administration of these agents has been tested in patients with motor incomplete spinal cord injury; only limited changes in walking performance have been noted. The resultant onset of weakness and increase in involuntary reflexes following motor incomplete SCI may partly be a result of damage to descending pathways to the spinal cord that control the release of serotonin. In models of SCI, for example, application of agents that simulate serotonin has been shown to change voluntary motor behaviors, including improvement of walking recovery. In humans following neurological injury, the effects of 5HT agents are unclear. Few previous reports indicate improved motor function following administration of agents which enhance the available serotonin in the brain, although some data suggests that increased serotonin may be beneficial. In this application, we propose to study the effects of clinically used agents that increase or decrease intrinsic serotonin activity in the brain on strength and walking ability following human motor incomplete SCI. Using detailed electrophysiological recordings, and biomechanical and behavioral measures, we will determine the effects of single or chronic doses of these drugs on voluntary and involuntary motor behaviors during clinical measures and walking measures. The novelty of this proposed research is the expectation that agents that increase serotonin activity may increase abnormal reflexes in SCI, but simultaneously help to facilitate motor and walking recovery. Despite potential improvements in voluntary function, the use of pharmacological agents that may enhance spastic motor behaviors following SCI is in marked contrast to the way in which drugs are typically used in the clinical setting.