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Spinal Cord Injuries clinical trials

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NCT ID: NCT03644277 Active, not recruiting - Clinical trials for Spinal Cord Injuries

A Multi-Center Clinical Trial in Individuals With Spinal Cord Injury

HANDS
Start date: July 1, 2018
Phase: N/A
Study type: Interventional

The overall objective of this project is to investigate the effectiveness of daily acute intermittent hypoxia therapy (dAIH), coupled with massed practice training, to improve upper-extremity function in individuals with chronic incomplete cervical SCI.

NCT ID: NCT03643770 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Effect of a Novel Intervention Using Daily Intermittent Hypoxia and High Intensity Training on Upper Limb Function in Individuals With Spinal Cord Injury

Start date: November 16, 2018
Phase: Early Phase 1
Study type: Interventional

Currently, there are a variety of approaches utilized in attempts to improve upper extremity function, including: traditional therapy, neuroprostheses, botulinum toxin injections, or surgical interventions. In addition, regenerative and restorative therapies, such as: epidural stimulation, functional electrical stimulation, and stem cell therapies, show promise in animal models, but are not ready for clinical translation. Subsequently, there is a clear need to develop new strategies that can stimulate spinal plasticity and strengthen existing synaptic connections in order to maximize the benefits of training paradigms. This study proposes the examine the effects of Acute Intermittent Hypoxia (AIH) in combination with upper extremity training, over the course of a month, to evaluate changes in upper extremity function, dexterity, and ability to complete activities of daily living. The use of acute intermittent hypoxia (AIH) has been demonstrated, through human and animal studies, to be an effective way of increasing spinal motor excitability and strengthening residual synaptic connectivity. AIH utilizes short duration (<2 min) exposures to reduced oxygen levels (~10% inspired oxygen), with alternating exposures to air with normal oxygen levels (~21% inspired oxygen). Previous publications demonstrate that AIH is a safe and effective intervention to modify motor function in individual with chronic incomplete spinal cord injuries. The use of AIH has been shown to influence the activation in musculature, within 60-120 minutes of administration. In addition, when coupling AIH with overground gait training, an increase in functional endurance, as evaluated through the 6 minute walk test, and gait speed, as evaluated through the 10 meter walk test, were demonstrated. In addition, the use of hypoxic training has been studied in healthy individuals and athletes; however, literature examining the effect of a single bout of AIH on performance is limited.

NCT ID: NCT03624218 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Outcomes After Spinal Cord Injury (OASIS)

Start date: February 21, 2018
Phase: N/A
Study type: Interventional

The study evaluates the effectiveness of Prolonged Exposure Therapy on a population of individuals with spinal cord injuries. Participants will be randomly assigned to either a treatment as usual or Prolonged Exposure therapy group.

NCT ID: NCT03592394 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Virtual Reality for Chronic Neuropathic Pain

Start date: July 2016
Phase: Phase 3
Study type: Interventional

The investigators hypothesize that SCI patients using immersive IVR training will show improved reduction of neuropathic pain that will outlast the training sessions and transfers into daily life.

NCT ID: NCT03559036 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Pediatric Locomotor Training Bladder Study

Start date: April 26, 2018
Phase:
Study type: Observational

Bladder dysfunction is one of the most important factors influencing duration and quality of life in children with spinal cord injury. Effective bladder control comprises a major aspect of a child's life with SCI and is especially challenging due to the rapid changes in a child's physical and cognitive development. Urological consequences secondary to a neurogenic bladder are responsible for many clinical complications post-spinal cord injury, including repeated urinary tract infections, autonomic dysreflexia, lifelong urologic care, and many hospitalizations. Alternative approaches to bladder management that focus on recovery of function and age-appropriate independence are needed. Prior research findings in our lab in adult participants indicate a benefit of locomotor training on bladder function. The purpose of this study is to determine with quantitative unbiased urodynamic outcome measures if locomotor training, provided to children with spinal cord injury, impacts the developing urinary system.

NCT ID: NCT03555838 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Combined Robotic Training and tDCS in Chronic SCI

Start date: May 1, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to establish the value of combined non-invasive stimulation (tDCS) and behavioral training (robotics) in SCI rehabilitation, and understand the mechanisms of this interaction and its relationship to functional outcome. The investigators hypothesize that supplementary tDCS will augment the functional improvement from robot-training, in chronic SCI.

NCT ID: NCT03505463 Active, not recruiting - Clinical trials for Spinal Cord Injury, Acute

The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury

Start date: May 1, 2018
Phase:
Study type: Observational

The study is a prospective cohort study designed to assess the diagnostic and prognostic potential of biomarker measurement in acute traumatic spinal cord injury (TSCI), and to examine the neuroinflammatory response to acute TSCI.

NCT ID: NCT03504826 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Walking Rehabilitation After Spinal Cord Injury: Locomotor Training Using Adaptive Robotics

Start date: November 29, 2018
Phase: N/A
Study type: Interventional

Locomotor training is an established rehabilitation approach that is beneficial for improving walking function in individuals with spinal cord injuries (SCIs). This approach focuses on repetitive practice and appropriate stepping movements to activate spinal neural networks and promote rhythmic motor output associated with walking. Assistance with stepping movements is often provided by physical therapists and trainers, but this can be costly and difficult to deliver in the cost-constrained U.S. healthcare market. Robotic devices have been used as an alternate method to deliver locomotor training, but current robotic approaches often lack the natural movement variations that characterize normal human stepping. Furthermore, studies to compare locomotor training approaches have not shown any specific benefits of using robotic devices. A new type of robotic device has emerged that uses an individual's muscle activation and stepping movements to control the robot during walking. This adaptive robotic device adjusts to the user's intentions and can assist with stepping during locomotor training in a manner that matches natural human stepping. While this type of adaptive robot has been preliminarily tested, the safety and efficacy of locomotor training using adaptive robotics are not well-established in patients with SCI. This is a critical step to determine if individuals with SCI may benefit from use of this device and for preliminary adoption of this technology. Recent studies have used the Cyberdyne Hybrid Assistive Limb (HAL) to deliver locomotor training and have reported outcomes suggesting that the HAL adaptive robot is safe and efficacious for walking rehabilitation in European SCI patients. Therefore this study will use the HAL adaptive robot to deliver locomotor training. This research is necessary to determine if use of the HAL is potentially beneficial and warranted for use with locomotor training and SCI patients receiving care in the U.S. Results of this study may contribute to the development and implementation of effective walking rehabilitation approaches for people with SCIs.

NCT ID: NCT03503513 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord Injury

Start date: August 24, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

A non-randomized study evaluating the efficacy of intravesical gentamicin on the occurrence rate of urinary tract infections and bladder complications in patients after spinal cord injury (SCI), and to assess its effectiveness in promoting overall quality of life (QOL), community living, and participation.

NCT ID: NCT03495986 Active, not recruiting - Metabolic Syndrome Clinical Trials

Spinal Cord Injury Exercise and Nutrition Conceptual Engagement

SCIENCE
Start date: June 10, 2021
Phase: N/A
Study type: Interventional

Evaluate and compare the health benefits of an at home exercise program using functional electrical stimulation (FES) for lower extremity exercise with diet versus a diet alone group in adults with spinal cord injury.