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Spinal Cord Injuries clinical trials

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NCT ID: NCT04211636 Not yet recruiting - Spinal Cord Trauma Clinical Trials

Autoimmunity And Immune Deficiency After Spinal Cord Injury: Association With Rehabilitation Outcomes

Start date: October 2023
Phase:
Study type: Observational

The SCIentinel-prolong study systematically analyzes humoral autoantibody responses and thier interaction with post-spinal cord injury (SCI) immune-deficiency and infections as well as their association with the clinical course of rehabilitation. Therefore, molecular and immunological tests in blood and cerebrospinal fluid specimen are combined with clinical outcomes ranging from neurological function, neuropathic pain and spasticity to walking tests and measures of independence in daily living within the first year after SCI. Including a control group with participants suffering from vertebral fractures without SCI allows to differentiate between neurological and general injury and treatment effects.

NCT ID: NCT04105296 Not yet recruiting - Clinical trials for Spinal Cord Injuries

Epidural Stimulation After Spinal Cord Injury

ESL-SCI
Start date: January 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the current study is to determine the effects of applying epidural stimulation (ES) on motor control recovery in Veterans with SCI. The intervention will be accompanied with the use of a powered exoskeleton (EKSO®) for 6 months to facilitate standing and to produce step-like movement in persons with chronic motor complete (AIS A or B) SCI and level of injury below C5 . Walking speed, distance, muscle activation pattern as measured by surface EMG and walking parameters including stand-up time, walking time, distance will be considered primary outcome variables. Cardiovascular performance, as measured by resting blood pressure and heart rate, peak oxygen consumption during walking, energy expenditure, whole and regional body composition assessments will also be measured. The effects of training (ES+EKSO) on , and speed of walking will also be evaluated.

NCT ID: NCT04008160 Not yet recruiting - Clinical trials for Spinal Cord Injuries

Intelligent Underwear (IU) in Paraplegics

ProTex
Start date: October 1, 2022
Phase:
Study type: Observational

Pressure injuries are a major problem in patients with no or limited mobility and sensation such as paraplegics. Changes in skin physiology like changes in skin perfusion, oxygenation and humidity may explain and help to detect pressure injury development earlier. Thus, these parameters may be used for continuous monitoring of skin health. So far, there is no measuring technology available which would allow to measure continuously and quantitatively the physiological parameters, which are essential in the development of pressure injuries, over a long period of time in the clinical setting. The goal of this pilot study is to test whether this wearable technology can be used for measurements of skin parameter and whether temperature, pressure, humidity, perfusion, and oxygenation can be measured safely and accurately. 10 healthy individuals and 10 individuals with spinal cord will be enrolled for measurements with this newly developed device over the ischium for 30 minutes. The reproducibility of the measurements will be investigated.

NCT ID: NCT03924388 Not yet recruiting - Clinical trials for Spinal Cord Injuries

Spinal Cord Stimulation and Autonomic Response in People With SCI.

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

Despite being studied less than half as frequently, autonomic dysfunction is a greater priority than walking again in spinal cord injury. One autonomic condition after spinal cord injury is orthostatic hypotension, where blood pressure dramatically declines when patients assume the upright posture. Orthostatic hypotension is associated with all-cause mortality and cardiovascular incidents as well as fatigue and cognitive dysfunction, and it almost certainly contributes to an elevated risk of heart disease and stroke in people with spinal cord injury. In addition, autonomic dysfunction leads to bladder, bowel, sexual dysfunctions, which are major contributors to reduced quality and quantity of life. Unfortunately, the available options for treating this condition, are primarily limited to pharmacological options, which are not effective and are associated with various side effects. It has been recently demonstrated that spinal cord stimulation can modulate autonomic circuits and improve autonomic function in people living with spinal cord injury. Neuroanatomically, the thoracolumbar sympathetic pathways are the primary spinal cord segments involved in blood pressure control. Recently, a pilot study has been published demonstrating that transcutaneous spinal cord stimulation of thoracolumbar afferents can improve cardiovascular function. However, some studies have shown that lumbosacral transcutaneous spinal cord stimulation can also elicit positive cardiovascular effects. Therefore, there is no consensus on the optimal strategy in order to deliver transcutaneous spinal cord stimulation to improve the function of the autonomic system, and it may be that lumbosacral (i.e. the stimulation site being used most commonly for restoring leg function is sufficient). Another key knowledge gap in terms of transcutaneous spinal cord stimulation is whether or not the current is directly or indirectly activating these spinal circuits. Last but not least, the effects of epidural spinal cord stimulation on the function of cardiovascular, bladder, bowel and sexual system in spinal cord injury have been investigated in no study yet. AIMS AND HYPOTHESES: Aim 1. To examine the effects of short-term (one session) transcutaneous spinal cord stimulation on the frequency and severity of episodes of orthostatic hypotension/autonomic dysfunction, and bladder, bowel, and sexual functions. These effects will be compared at two sites of stimulation. Hypothesis 1.1: Short-term transcutaneous mid-thoracic cord stimulation will mitigate the severity and frequency of orthostatic hypotension/autonomic dysfunction. Hypothesis 1.2: Lumbosacral transcutaneous spinal cord stimulation will improve bladder, bowel, and sexual functions. Aim 2. To examine the effects of long-term (one month) transcutaneous spinal cord stimulation on the severity and frequency of orthostatic hypotension/autonomic dysfunction. Hypothesis 2.1: Long-term stimulation of the mid-thoracic cord will result in sustained improvements in mitigated severity and frequency of orthostatic hypotension/autonomic dysfunction that is not dependent on active stimulation. Hypothesis 2.2: Long-term lumbosacral transcutaneous spinal cord stimulation will result in sustained improvements in bowel, bladder, and sexual function that is not dependent on active stimulation. Aim 3: To examine the effects of short-term (one session) epidural spinal cord stimulation on the severity and frequency of orthostatic hypotension/autonomic dysfunction, and bladder, bowel, and sexual functions. Hypothesis 3.1: Epidural spinal cord stimulation will mitigate the severity and frequency of orthostatic hypotension/autonomic dysfunction and improve bladder, bowel, and sexual function. Hypothesis 3.3: There is no significant difference between immediate effects of lumbosacral transcutaneous spinal cord stimulation and epidural spinal cord stimulation on bladder, bowel, and sexual function. For aim 1, 14 participants with spinal cord injury and no implanted electrodes on the spinal cord will be recruited. Participants will randomly receive one-hour stimulation under each of the two stimulation conditions in a crossover manner: Mid-thoracic and Lumbosacral. For aim 2, 28 individuals with spinal cord injury and no implanted electrode will be pseudo-randomized (1:1) to one of two stimulation sites. Participants will receive one-hour stimulation, five sessions per week for four weeks. Cardiovascular and neurological outcomes will be measured before the first stimulation session and after the last stimulation session. For aim 3, 4 participants with spinal cord injury with implanted electrodes on the spinal cord will be recruited to study the immediate effects of invasive epidural spinal cord stimulation. All outcomes will be measured in two positions: a) Supine, b) ~ 70° upright tilt-test. Additionally, bowel, bladder, and sexual functions in project 2 will be assessed weekly.

NCT ID: NCT03567902 Not yet recruiting - Clinical trials for Intubation;Difficult

C-MAC Videolaryngoscope Intubation and Cervical Spine Motion

Start date: June 2018
Phase: N/A
Study type: Interventional

The aim of the study is to compare the effect of the C-MAC videolaryngoscope intubation technique vs. the conventional direct laryngoscope intubation technique on the cervical spine motion during intubation in patients with the simulated cervical immobilization.

NCT ID: NCT03420170 Not yet recruiting - Clinical trials for Spinal Cord Injuries

Physical Fitness, Exercise Self-efficacy, Physical Activity Level in People With Spinal Cord Injury (SCI)

Start date: April 2018
Phase: N/A
Study type: Interventional

This is a single blind randomized controlled trial study which will conducted on people with paraplegia wheelchair users. The objectives of this study is to investigates the effects of 16 weeks of 'Graded Exercise Integrated Education' over conventional physical therapy on physical fitness, exercise self-efficacy and the level of physical activity. There will be a significant difference between the experimental and control group.

NCT ID: NCT03394560 Not yet recruiting - Clinical trials for Spinal Cord Injuries

rTMS and Body Weight-support Treadmill Training After Incomplete Spinal Cord Injury

Start date: January 30, 2018
Phase: Phase 2
Study type: Interventional

The aim of this study is to verify the efficacy of body weight-support treadmill training combined with high-frequency rTMS in improving the sensory-motor function of adult patients with chronic incomplete thoracolumbar spinal cord injury.

NCT ID: NCT03171207 Not yet recruiting - Stroke Clinical Trials

Evaluation of a Novel Gait Training Device to Support Body Weight

Start date: June 2017
Phase: N/A
Study type: Interventional

A novel body weight support device that uses pressurized pants may provide advantages in delivering gait therapy. The objectives of this study are to test the following hypotheses that 1) the novel device will allow for increased body weight support while improving or maintaining the same level of patient comfort; 2) the novel device will yield greater patient satisfaction with gait therapy relative to current harness systems; 3) therapists will be more satisfied with the use of the novel device relative to current harness systems; 4) the use of the novel device will require less total therapist time than a harness comparator; 5) the use of the novel device will increase therapeutic treatment time when compared with current harness systems.

NCT ID: NCT03108859 Not yet recruiting - Spinal Cord Injury Clinical Trials

Pre-and In-hospital First Aid Programs and Specifications for Spine and Spinal Cord Injury in Beijing of China

Start date: May 2017
Phase: N/A
Study type: Observational

To establish a spine injury and spinal cord injury (SCI) treatment database; to complete pre- and in-hospital evaluation of spine injury and SCI, develop and optimize first aid procedures, form pre-and in-hospital standardized training program for the treatment of spine injury and SCI; to develop first aid guidelines and establish an evaluation and treatment system for early surgery, as far as possible to save the spinal cord function and reduce the degree of disability; to form expert consensus on acute SCI and "green channel" patterns, will be promoted in hospitals in Beijing and other cities of China, so as to improve the level of first aid treatment of acute spine injury and SCI in Chinese cities, and to reduce the occurrence of secondary injury and severe dysfunction due to improper treatment.

NCT ID: NCT03103516 Not yet recruiting - Clinical trials for Spinal Cord Injuries

Epidural Decompression Surgery Within 24 Hours After Acute Spinal Cord Injury Improves Spinal Nerve Function

Start date: August 2017
Phase: N/A
Study type: Interventional

To compare the effects of early (within 24 hours) and delayed (exceed 24 hours) epidural decompression surgery on the recovery of spinal nerve function in patients with acute spinal cord injury (complete and incomplete) at postoperative 6 months.