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Spinal Cord Injuries clinical trials

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NCT ID: NCT06351852 Recruiting - Clinical trials for Spinal Cord Injuries

Transdermal Administration by a Novel Wireless Iontophoresis Device

Start date: March 22, 2022
Phase: Early Phase 1
Study type: Interventional

Persons with spinal cord injury (SCI) have neurogenic bowel disorders which is associated with significant morbidity. The negative impact of bowel complications is often at the top of the list of problems reported by persons with SCI. Despite the magnitude of the problem of bowel dysfunction in persons with SCI, and the associated reduction in quality of life, this condition has yet to be effectively treated. The investigators have developed a novel dual drug combination to elicit a safe and predictable bowel evacuation (BE). The ability to move the bowel contents along to the rectum was severely impaired primary because of poor gut contractions on the left side of the colon, as shown by our team of investigators. To address this problem, a dual medication combination (neostigmine and glycopyrrolate) was developed that safely and predictably caused the bowel to empty after delivering these drugs into a vein (intravenously) or into the muscle bed (intramuscularly). Because no one likes needles, and because of the practical limits of administering medications on a routine basis by the use of needles, especially in persons with SCI because of their other health considerations, the investigators have devised a new approach: driving these medications across the skin and into the circulation of the body by applying an electrical current that is too small to feel (iontophoresis). The proposed research project to determine the safety of positively charged compounds (e.g., vitamin B12, NEO, and GLY) administered transcutaneously by the prototype wireless ION device and to compare the pharmacokinetic profiles of transcutaneous administration of NEO and GLY by the wireless ION device to a commercially available wired ION device. The potential administration of any number of other positively charged agents by this wireless prototype may be a clinically relevant outcome of this work. The ability to use a wireless ION device is far more practical for patients to use, especially those with SCI, which will permit the self-administration of these agents in the home setting to induce a bowel evacuation.

NCT ID: NCT06349434 Recruiting - Clinical trials for Upper Extremity Dysfunction

The Utilization Effects of Powered Wearable Orthotics in Improving Upper Extremity Function and ADL in Persons With SCI

Start date: October 15, 2023
Phase: N/A
Study type: Interventional

To evaluate the usefulness of an upper extremity (UE) assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury (iSCI). The Department of Defense is supporting this study.

NCT ID: NCT06330181 Recruiting - Clinical trials for Spinal Cord Injuries

Virtual Walking Therapy for Neuropathic Pain Following Incomplete Spinal Cord Injury

Start date: March 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with incomplete spinal cord injury.

NCT ID: NCT06313515 Recruiting - Clinical trials for Spinal Cord Injuries

Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for Cardiovascular Recovery in SCI

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Spinal cord injury (SCI) can make it hard for the body to self-regulate some of its automatic functions like blood pressure, breathing, and heart rate. This can also make it hard for those living with SCI to exercise or complete their usual daily activities. The goal of this randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with non-invasive transcutaneous spinal cord stimulation (tSCS) for cardiovascular recovery in adults aged 21-65 following chronic motor-complete spinal cord injury (SCI) at or above the thoracic sixth spinal segment (≥T6). The main questions the study aims to answer are: - Conduct tSCS mapping to determine the most effective location and stimulation intensity for BP control in individuals with motor-complete SCI ≥ T6. - Evaluate the effects 8 weeks of targeted tSCS paired with arm-crank exercise compared to sham stimulation with exercise on improving cardiovascular function in individuals with motor-complete SCI ≥T6. - Evaluate the dosage-response of 8 weeks vs. 16 weeks of targeted tSCS paired with arm-crank exercise on cardiovascular function in individuals with motor-complete SCI ≥T6. - Explore the mechanisms involved in cardiovascular recovery with long-term tSCS paired with arm-crank exercise. Participants will: - Receive either transcutaneous spinal cord stimulation or "sham" spinal cord stimulation while exercising on an arm-crank bicycle in the first 8 weeks. - Come in for approximately 60 visits over a 6-month period. This includes 2, 8-week periods where the investigators will ask participants to come in 3x per week for spinal cord stimulation and exercise. - During assessment visits the researchers will perform a variety of exams including a neurologic, cardiovascular, pulmonary, physical, and autonomic exam, and will ask questions about quality of life and functioning. Researchers will compare those who receive tSCS and do moderate arm-crank exercise to those who receive a sham stimulation and do moderate arm-crank exercise to see if tSCS is effective at improving cardiovascular and autonomic functioning in those with SCI.

NCT ID: NCT06309888 Recruiting - Spinal Cord Injury Clinical Trials

Magnetic Resonance Imaging of Cognitive Deficits in the Brain of Individuals With Spinal Cord Injury

SCI_Cog
Start date: February 1, 2024
Phase:
Study type: Observational

In the case of spinal cord injury, rehabilitation is particularly focused on motor skills. Non-motor impairments such as thinking difficulties did not receive a lot of attention to date. In this research project, the investigators want to find out how thinking difficulties become noticeable in the brain with spinal cord injury. Participation procedure: Participants who take part will be asked to come to an examination once. The duration of the examination is between 2 and 2.5 hours (including around 55 minutes in the magnetic resonance imaging scanner, including preparation and follow-up).

NCT ID: NCT06302478 Recruiting - Clinical trials for Spinal Cord Injuries

5E Program for Preventing Venous Thromboembolism in Patients With Spinal Cord Disorders

Start date: March 12, 2024
Phase: N/A
Study type: Interventional

The goal of this quasi-experimental study is to examine the effects of a venous thromboembolism prevention program, or "5E" program, on the rates of venous thromboembolism in patients with spinal cord disorders. The main questions it aims to answer are: - Will participants receiving the 5E program have lower rates of venous thromboembolism compared to those receiving the usual care? - Will participants receiving the 5E program have lower scores of venous thromboembolism signs and symptoms compared to those receiving the usual care? - Will the average thigh and calf circumferences of participants before and after receiving the 5E program be different? Participants in the intervention group will receive the 5E program, including - Education: health education regarding venous thromboembolism prevention - Elevation: leg elevation of 10-20 degrees - Exercise: ankle exercises - Enough fluid: adequate fluid uptake - Early application of intermittent pneumatic compression (IPC): IPC use within 48 hours after admission

NCT ID: NCT06288763 Recruiting - Tetraplegia Clinical Trials

Nerve Transfer to Improve Function in High Level Tetraplegia

Start date: February 5, 2024
Phase:
Study type: Observational

The goal of this observational study is to determine if nerve transfer surgeries improve upper extremity function and quality of life in patients with a high level cervical spinal cord injury. Participants will: - undergo standard of care pre- and post-op testing and study exams - complete pre- and post-questionnaires - undergo standard of care nerve transfer surgeries - follow-up with surgeon at 6/12/18/24/36 and potentially at 48 months - attend therapy at local therapist for up to 2 years postop.

NCT ID: NCT06274658 Recruiting - Clinical trials for Spinal Cord Injuries

The Effects of an Acute High-intensity Exercise on Heart and Brain Function in People With Spinal Cord Injury

Start date: February 14, 2024
Phase:
Study type: Observational

The heart and brain are regulated by the autonomic nervous system. Control of these organs can be disrupted in people with spinal cord injury (SCI). This may affect their ability to regulate blood pressure during daily activities and process the high-level information. Previous studies show that high-intensity exercise induces better outcomes on heart and information processing ability in non-injured people compared to moderate-intensity exercise. However, it is unknown the effects of high-intensity exercise on heart and brain function in people with SCI. Therefore, this study aims to examine the effects of a single bout of high-intensity interval training on heart and brain function in this people with SCI compared to age- and sex-matched non-injured controls.

NCT ID: NCT06272279 Recruiting - Clinical trials for Spinal Cord Injuries

Neuromodulation With Spinal Stimulation Methods

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

This is a pilot research study to test the protocols needed for transcutaneous spinal electrical stimulation in persons living with spinal cord injury (SCI). Up to 24 participants will be enrolled. A variety of stimulation parameters and outcome measures will be assessed.

NCT ID: NCT06260735 Recruiting - Clinical trials for Spinal Cord Injuries

Non-invasive Spinal Cord Stimulation After Spinal Cord Injury

SCI-ES-WALK
Start date: June 15, 2023
Phase: N/A
Study type: Interventional

Spinal cord injury (SCI) is a central nervous system injury that often leads to motor dysfunction. Non-invasive electrical stimulation of the spinal cord has been recognized as a potential method of reactivating lost spinal neural networks to improve motor recovery and exercise response after SCI. Trans-spinal electrical stimulation (ts-ES) has been found to increase functional gains in people after SCI when applied in combination with other motor training protocols. This project aims to evaluate the effects of non-invasive lumbar spinal cord electrical stimulation on the motor function of trunk and lower limbs in people with SCI after augmenting their locomotor training (treadmill stepping) with step-cycle-based electrical peripheral neural stimulation methods.