Active clinical trials for "Spinal Cord Injuries"

The conventional treatment of spinal cord injury (SCI) includes physical therapy and rehabilitation and in some cases may require surgical intervention. Although improved emergency care and aggressive treatment can help in preventing further damage and even restore minimal sensory functions, still a large proportion of patients suffer with prolonged disabilities. It led neurologists to search out for new treatment options for this otherwise debilitating disorder. Recent advances in research have developed a better understanding of stem cell biology especially their role in tissue repair and regeneration. Encouraging results in pre-clinical phase and limited human trials have proved that stem cells can be safely and effectively delivered to the injured site for regeneration of damaged tissue. Although a variety of cell types have been tried for their role in repair of spinal cord injury, majority of clinical trials employed stem cells taken from bone marrow especially mesenchymal stromal cells (MSC). Bone marrow MSCs are a good choice for regenerative therapies owing to advantages like ease of collection and ex-vivo culturing, immune tolerance and their ability to differentiate into a variety of cell types including neuronal lineage cells. Intravenous application or direct injection of MSCs into cerebrospinal fluid (CSF) via lumber puncture in animal models of SCI and brain trauma had shown that MSCs can migrate towards and integrate into injured spinal tissue and reduce cyst size and increase functional recovery. The literature indicates that acute, sub-acute and chronic injury can be a therapeutic target for MSC grafting. The mechanism of action may however vary among these conditions. In acute phase, MSC administration play anti-inflammatory role, while in sub-acute/chronic setting it may be used as neurostimulator and for cell bridging effect and possibly glial or neuronal cell replacement. The investigators propose a non-randomized, single group, open label, phase-I, interventional study to evaluate the safety and efficacy of intrathecal delivery of patient's own (autologous) bone marrow mesenchymal stem cells for treatment of spinal cord injury. This will include determination of functional recovery (neuro-muscular control and sensation) in the affected area and overall improvement in quality of life of the patients and also take into account any side effects, if observed.

Evaluation of Wire Electrodes to Activate the Expiratory Muscles to Restore Cough

This research investigates the use of autologous bone marrow stem cells in patients with spinal cord injury.

The long-term goal of this project is to develop rehabilitation strategies that facilitate optimal restoration of skilled hand use in individuals with spinal cord injury (SCI). The objective of the studies proposed in this application is to determine whether a protocol of massed practice + somatosensory stimulation (MP+SS) is more effective for improving skilled hand use compared to a somatosensory stimulation (SS) alone, and to determine whether these approaches are each more effective than traditional therapy (consisting of conventional resistance training; CRT). Specific Aim I: In individuals with chronic incomplete tetraplegia, quantify changes in skilled hand use and sensory function associated with either: massed practice training combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS), or control (conventional resistance training [CRT]), and compare differences among groups. The investigators hypothesize that: H1.1: At the end of 4 weeks, gains in scores on standardized tests of skilled hand motor function (Jebsen-Taylor Hand Function Test and Chedoke-McMaster Arm and Hand Activity Inventory) and sensory function (quantitative sensory tests; QST) will be greater in individuals who are trained using MP+SS compared to the SS and RT groups. H1.2: At the end of 4 weeks, gains in scores on standardized tests of skilled hand motor function and sensory function tests will be greater in individuals who are trained using SS compared to CRT. H1.3: At 6 months post training, motor and sensory gains will be retained by the MP+SS and SS groups. Specific Aim 2: In individuals with chronic incomplete tetraplegia, quantify changes in cortical and spinal neurophysiology associated with either: massed practice combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS), or control (conventional resistance training [CRT]), and compare differences among groups. The investigators hypothesize that, after 4 weeks: H2.1: Measures representing cortical neurophysiologic function (i.e., motor-evoked potential amplitude and location of cortical map) will show greater change in the direction of more normal values in individuals who are trained using MP+SS compared to the SS and the CRT groups. H2.2: Measures representing spinal neurophysiologic function (i.e., F-wave and H-reflex amplitude) will show greater change in the direction of more normal values in individuals who are trained using SS compared to the MP+SS and the CRT groups. H2.3: There will be a positive relationship between change scores associated with functional outcome measures and cortical neurophysiologic outcome measures in the MP+SS group; there will be a positive relationship between change scores associated with the functional outcome measures and spinal neurophysiologic outcome measures in the SS group. Specific Aim 3: In individuals with chronic incomplete tetraplegia, quantify changes in self-assessment of quality of life and societal participation associated with massed practice combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS) or control (conventional resistance training [CRT]), and compare difference among groups. The investigators hypothesize that: H3.1: Gains in scores on standardized measures of quality of life (Medical Outcomes Study Short Form 36 [SF-36]) and societal participation (Impact on Participation and Autonomy Questionnaire [IPAQ]) will be greater in individuals who are trained using MP+SS compared to both the SS and the CRT groups. H3.2: Gains in scores on standardized measures of quality of life and societal participation will be greater in individuals who are trained using SS compared to the CRT group. H3.3: At 6 months post training, gains in the quality of life and the societal participation measures will be retained by the MP+SS and SS groups. Risks: This is a low risk study that investigates the effects of standard rehabilitation and exercise interventions on hand/arm function in individuals with SCI. All devices are considered minimal risk devices by the FDA.

Loss of hand function is one of the most devastating consequences of tetraplegia because of the severe impact on activities of daily living (ADL) and the resultant dependency on others. This multi-centre study in 78 participants will measure whether additional hand therapy provided via an electrical stimulator glove and specialised computer workstation improves hand function in people with tetraplegia.

The loss of muscle contraction (paralysis) removes an important stimulus for maintenance of overall health for individuals with complete spinal cord injury (SCI). Increased protein catabolism (atrophy) limits important stresses to the skeletal system. Bone loss doubles the risk of fracture and contributes to increased mortality in Veterans with SCI. Metabolic syndrome and diabetes lead to heart disease in Veterans with SCI at higher rates than the general population. Exercise methods to sustain muscle tissue, bone density, and metabolic stability after SCI are lacking scientific justification. If left unchecked, the secondary complications of SCI can be health limiting or even life threatening to Veterans with paralysis. The importance of maintaining the health of the musculoskeletal system after SCI has never been greater as a cure for paralysis may become a reality. Contemporary rehabilitation interventions lack the ability to functionally load muscle tissue, quantify the dose of load, stress the cardiovascular system, monitor the overall stresses during daily exercise training, or offer portability to improve compliance with the exercise. The long-term goal of this project is to establish the optimal dose of muscle and bone stress during functional exercise in order to improve the health of Veterans with complete paralysis. The practical outcome of this research is to offer a form of activity that is feasible, portable, and grounded in sound scientific principles. The scientific goal is to understand whether the dose of force generated in paralyzed muscle via evoked contractions is critical to muscle atrophy/hypertrophy molecular pathways, physiologic performance, and insulin sensitivity. The investigators will administer various doses of muscle force by manipulating the frequency of electrical stimulation while keeping stimulation current (i.e. muscle fiber recruitment) constant. Interestingly, no previous study has examined the dose of muscle force necessary to trigger adaptations in protein synthesis/degradation pathways. The investigators wish to discover the most effective method to maintain the molecular and physiologic properties of paralyzed muscle. The investigators believe such a method will be in urgent demand as a co-intervention with pharmaceutical strategies in post-SCI rehabilitation.

Spinal cord injury (SCI) leads to muscle atrophy, hyperreflexia and spasticity, symptoms that decrease quality of life and prevent effective rehabilitation. Previous findings from our labs found that a passive cycling exercise program, motorized bicycle exercise training (MBET), in adult spinally transected animals reduced muscle atrophy and normalized hyperreflexia. We found that MBET could prevent the onset of hyperreflexia after spinal transaction, that MBET could also be used to rescue from hyperreflexia once it had set in, and that MBET could induce savings in normalization of reflexes after MBET ceased. We also demonstrated that MBET was effective in rescuing from hyperreflexia in a chronic ASIA B SCI patient, and that short-term MBET could lead to brief savings in normalization of reflexes once MBET ceased. The proposed studies will test the ability to MBET to prevent the onset of hyperreflexia in a group of acute SCI patients trained before hyperreflexia has had a chance to set in. In addition, the proposed research will attempt to confirm the possibility that long-term MBET in chronic SCI patients will rescue from hyperreflexia once it has set in, and also produce significant savings in normalization of reflexes if carried out for long periods of time. We will also test the possibility that MBET in acute and/or chronic SCI patients could reduce or prevent muscle atrophy. The experimental design calls for assessing muscle mass using MRI scans, bone density using Dual-Energy X-ray Absortiometry (DEXA) scans, spasticity measures and electrophysiological measurements to determine low frequency habituation of the H-reflex. Assessments will be carried out before MBET, during a 25 week MBET block of time, and during a 12 week post MBET monitoring period. Changes in muscle mass, bone density, spasticity scales and H-reflex habituation will be compared across these interventions and between treated SCI victims and a group of control acute and chronic SCI victims undergoing standard of care during the same period.

This study was initially designed to test the efficacy of Venlafaxine HCl in reducing incidence of the onset of major depression after a new spinal cord injury (SCI). After several protocol modifications, the purpose of the study is to test the effectiveness of a sub-therapeutic dose of Venlafaxine HCl to reduce mild to moderate symptoms in persons with SCI.

This is a randomized, placebo-controlled, double-blinded trial. Forty patients will be randomized into two groups. The subjects in the Treatment Group will be administered with lithium carbonate, while the Control Group will receive placebo. Each subject will receive oral lithium carbonate or placebo for six weeks. In the treatment group, the dose will be adjusted according to the serum lithium level while in the control group there will be a sham adjustment. The outcomes will be assessed 6 weeks and 6 months after the onset of the medication. The outcomes will be compared with baseline pre-treatment data to obtain "neurological change scores." The efficacy and safety will be analyzed comparing the results of the treatment group with those of the control group.

This research study will test to see if people who receive pregabalin after their spinal cord injury will develop less nerve damage pain than people who do not receive it.