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Spinal Cord Injury clinical trials

View clinical trials related to Spinal Cord Injury.

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NCT ID: NCT05180227 Recruiting - Spinal Cord Injury Clinical Trials

Transcutaneous Stimulation in Spinal Cord Injury

SCI
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Cardiovascular disease has become the leading cause of death in the spinal cord injury population. Increased reliance on the renin-angiotensin-aldosterone system (RAAS) is believed to decrease falls in blood pressure when moving from a laying down position to upright; however, findings in the general population link the RAAS with remodeling and restructuring of the arterial walls. Therefore, intervention to stabilize and normalize blood pressure should be a priority in individuals with spinal cord injury who have low blood pressure. Advances in stimulation on the skin of the spinal cord offer an approach to restore cardiovascular control and improve blood pressure regulation; however, electrode placement and stimulation parameters needed to increase blood pressure are not well understood. Therefore, the aim of the study is to identify placement of electrodes on the skin, and frequency and amplitude of the stimulation to regulate blood pressure.

NCT ID: NCT05157282 Recruiting - Spinal Cord Injury Clinical Trials

Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia

Start date: January 25, 2023
Phase: N/A
Study type: Interventional

In support of the long-term goal of developing new strategies to increase limb function after SCI, the objectives of this proposal are to: 1) Examine the behavioral and physiological effects of TESS on upper-limb muscles after cervical SCI; and 2) Maximize the recovery of reaching and grasping potential by using tailored TESS in a task-specific manner with motor training. Veterans with cervical spinal injuries and healthy volunteers will be recruited for this study.

NCT ID: NCT05142943 Recruiting - Spinal Cord Injury Clinical Trials

Effectiveness of Virtual Bodily Illusion Intervention in Upper Limb Motor Function in People With Incomplete Spinal Cord Injury.

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Previous studies have shown that the neuroplasticity of the residual corticospinal fibers, the motor cortex and the spinal neurons plays an important role in the spontaneous functional recovery of people with neurological or musculoskeletal pathology. However, it is also possible to stimulate the neuroplasticity mechanisms of these structures through techniques aimed at rehabilitating different deficits (for example, motor function or sensitivity). In general, intervention programs are usually carried out, in most cases, using low-cost strategies such as therapeutic physical exercise programs. The objective of this study is to analyze the effectiveness of visual illusion therapies in combination with conventional exercises on the symptoms and signs related to incomplete spinal cord injury that affects the upper limb. The study will include the realization of three measurements that will be carried out one day before starting the program, one day after finishing it, and one month later (follow-up). The clinical assessment will be composed of the study of the following variables: Motor function and motor skills, Upper limb isometric force, Muscle activation, Muscle tone, Quality of life, Functionality. All interventions will last eight weeks and will be planned according to the availability of volunteers. In each session, it will be recorded if any type of adverse effect occurs. There will be four types of interventions: i. Visual Illusion (IV) and therapeutic exercise program (PE), ii.placebo and PE, iii. IV, iv. IV placebo.

NCT ID: NCT05118971 Completed - Spinal Cord Injury Clinical Trials

Comparison of Muscle Activity in Exercise Bike and Elliptical Trainer in Individuals With Spinal Cord Injury

Start date: August 1, 2020
Phase:
Study type: Observational

Spinal cord injury is caused by any harmful process in the spinal cord, impairing its function, generating loss of muscle strength, impairing orthostatism and walking. In rehabilitation, some strategies are used to activate the muscles involved in the gait of these individuals, including the ergometric bicycle and the elliptical. Understanding the pattern of muscle activation generated by these methods is important to answer questions arising from clinical practice. Thus, we seek to verify the pattern of muscle activation of the vastus laterals, vastus medialis, gluteus medius, tibialis previous, rectus abdominis and paravertebral muscles during exercises with ellipticals and ergometric bicycle with and without electromyography biofeedback in individuals with spinal cord injury. Cross-sectional study of the type crossover. Individuals will sign the Informed Consent Form (FICF) and answer the identification form. They will be evaluated for functionality using the Functional Independence Measure (FIM), injury classification by the American Spinal Injury Association (ASIA) and muscle tone by the modified Ashworth scale. Later, they will be randomized to define the order of the devices in which they will be evaluated. Muscle activity will be verified with electromyography of the paravertebral, abdominal, vastus laterals, vastus medialis, gluteus medius and tibialis anterior unilateral muscles on the right side of individuals, comparing muscle activation during exercise cycling, elliptical and adding biofeedback in both modalities. The wash-out interval between each evaluation will be 7 days. We hypothesize that the elliptical with biofeedback will cause greater activation of the assessed muscles.

NCT ID: NCT05041114 Withdrawn - Clinical trials for Amyotrophic Lateral Sclerosis

SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis

Start date: April 21, 2022
Phase: N/A
Study type: Interventional

The Synchron Motor Neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility. The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.

NCT ID: NCT05008484 Active, not recruiting - Spinal Cord Injury Clinical Trials

Effects of Electrical Stimulation and Vitamin D Supplementation on Bone Health Following Spinal Cord Injury.

Start date: October 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Neurogenic osteoporosis is a common complication of spinal cord injury (SCI) that is associated with low impact bone fractures. It is concerning that more than 46,000 Veterans affected with SCI and are at risk of osteoporosis and possible low impact fractures. About fifty percent of all individuals with SCI will develop low impact fracture in their life time. The management of osteoporosis-related fractures can impose substantial economic burden on the health care system, the individual and the families. Previous studies did not succeed in reversing the process of bone loss after SCI. In the present pilot study, we will evaluate the effect of Neuromuscular Electrical Stimulation Resistance Training in combination with oral Vitamin D supplementation, on bone quality in Veterans with chronic SCI, using a randomized experimental design.

NCT ID: NCT04971408 Recruiting - Spinal Cord Injury Clinical Trials

Impact of Passive Heat on Metabolic, Inflammatory and Vascular Health in Persons With Spinal Cord Injury

SCIPHS
Start date: July 1, 2022
Phase: Early Phase 1
Study type: Interventional

SCI results in higher incidence of heart disease and diabetes and heart disease is the most common cause of death. Chronic inflammation, deleterious changes in vascular structure and impaired glucose metabolism are risk factors that contribute to both heart disease and diabetes. While exercise can help reduce these risk factors, paralysis and impaired accessibility often precludes exercise in persons with SCI. New research in able-bodied persons demonstrates passive heating decreases inflammation and improves vascular function. Similar studies in persons with SCI suggest they may also have the same health benefits however these studies only investigated the impact of short term (one episode) passive heating (as opposed to repeated bouts). Repeated bouts of heat exposure will likely be required to impact chronic inflammation, but this has never been tested in persons with SCI. This study will test the impact of repeated bouts (3x/week) of passive heat stress over a longer term (8 weeks) on inflammation, metabolism and vascular function.

NCT ID: NCT04955509 Not yet recruiting - Spinal Cord Injury Clinical Trials

A Scar Recognition Software for Chronic Spinal Cord Injury (SCI)

Start date: September 1, 2021
Phase:
Study type: Observational

To construct and validate a software to recognize scar for patients with chronic SCI based on multimodal MRI.

NCT ID: NCT04889092 Recruiting - Spinal Cord Injury Clinical Trials

Blood Flow Restriction Exercise for Those With SCI

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Spinal cord injuries (SCI) are among the most debilitating conditions an individual can sustain with the estimates of SCI incidence in the United States at 12,000 new cases per year. The loss of innervation to the tissues muscle below the level of the lesion results in reduced physical activity which leads to an array of secondary complications including muscle atrophy, cardiovascular and metabolic disease, obesity and vascular dysfunction. This further leads to exercise intolerance, reduced quality of life and depression. Although current rehabilitative programs focus on improving muscle strength in this population, the efficacy of these programs is challenged by the injury related motor impairment, which limits the exercise intensity and subsequent positive muscular adaptations. Therefore, development of an exercise program that promotes maximal muscular adaptations to light intensity exercise could greatly improve the efficacy of rehabilitation in the SCI population and help restore functional capacity and quality of life for these individuals. Blood flow restriction (BFR) exercise has shown tremendous promise for improving muscle size and strength in a variety of healthy and clinical populations, however the benefits of BFR exercise for those with SCI has not been established. Thus, the purpose of this Merit proposal is to conduct a comprehensive study that explores the benefits and risks of BFR exercise in the incomplete SCI population. In general individuals with chronic incomplete SCI will be recruited to partake in two 8-week training periods (20 sessions) that involve traditional knee extension/flexion exercise or knee extension/flexion exercise with blood flow restriction. There will be a series of measurements before and after the 8-week intervention to look at changes in muscle and vascular function. Specific Aim 1 will determine how the 8-weeks of BFR exercise influenced muscle strength (Biodex isokinetic dynamometer), muscle cross sectional area and volume (CTscan) and fatigue resistance. Specific Aim 2 will determine how this novel 8-week training intervention impacts peripheral vascular function. Specifically, changes in nitric oxide mediated endothelial function will be determined through tests of flow mediated dilation, changes in endothelial function of the microvascular network will be determined through assessments of reactive hyperemia and changes in arterial stiffness will be determined through measurements of pulse wave velocity. Specific Aim 3 will focus on the safety of BFR exercise for the SCI population. Those with SCI are at greater risk for thrombosis and DVT compared to able bodied individuals. Although unlikely, the introduction of temporary blood stasis during BFR exercise might augment this risk. Thus, the third aim of this study will be to determine changes in innate immune activation and thrombosis risk. Specifically, blood will be collected at multiple timepoints throughout the training intervention and analyzed for hypoxia-inducible factor 1-alpha, neutrophil extra cellular traps (which act as prothrombotic scaffolds), neutrophil-platelet aggregates and inflammatory cytokines. Ultimately, if the improvements in muscle and vascular function following BFR resistance exercise is greater than the traditional resistance exercise often performed in rehabilitation settings, without increasing risk for DVT, it should be incorporated into the long-term rehabilitation programs for Veterans with SCI.

NCT ID: NCT04887688 Recruiting - Diabetes Clinical Trials

Exciflex for Chronic Wound Therapy

Start date: October 5, 2022
Phase: N/A
Study type: Interventional

Objectives: The study objective is to carry a pilot clinical assessment comparing the exciflex bandage to standard of care (SoC) for ischemic wounds and will involve participants who are Veterans with lower extremity ischemic wounds. Research Plan: The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of exciflex in clinical use. Methodology: All participants with chronic ischemic wounds treated at LSCDVAMC will be potentially eligible for the study. Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care. In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include; (1)Age less than 18 years and (2)Pregnancy. Clinical Significance: Chronic ischemic wounds fail to heal normally and are a major challenge in the long-term care of many Veterans. The exciflex bandage can improve outcomes and lower cost by automatically delivering electrotherapy without disturbing the wound dressing for up to seven days, unless indicated. The overall study goal is to complete pre-market testing and evaluation of the exciflex bandage system.