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22 recruiting in OH
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Restoration of Hand Function in Cervical SCI

Spinal Cord Injury Cervical

The purpose of this study is to evaluate a new method of restoring hand function to people with spinal cord injury. Current methods to restore hand function include tendon transfers and nerve transfers. This study will evaluate the grasp strength that can be achieved with a small, implantable stimulator. KeyGrip is an investigational device that works by activating paralyzed muscles with low levels of electrical current. The word "investigational" means the study device is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA) for the use being studied. Hypothesis. The study is designed to explore the feasibility of this approach; no hypothesis is planned at this stage

Cleveland, OH18+ yrsAll genders
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Implant for Walking After Incomplete SCI

Spinal Cord Injury (SCI) ยท Gait

This is a device study that will evaluate the effect of an implanted stimulator on improving walking in people with incomplete spinal cord injury. There are two phases in the study: 1) Screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) Implantation, controller development, and evaluation - this phase includes implanting the device and setting the individual up for system use, creating controllers for walking, and evaluating the effect of the device over a couple years.

Cleveland, OH18โ€“75 yrsAll genders
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Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic

Spinal Cord Injury ยท Pressure Injury

Spinal cord injury (SCI) is a permanent condition affecting every aspect of life including health, daily activities, and participation and quality of life. Persons with SCI are at high risk of pressure injury (PrI) throughout their lives due to loss of sensation, nerve damage and immobility. PrIs are local areas of damage to the skin and underlying soft tissue caused by pressure and shear commonly located over bony prominences. While most PrIs are hospital- or nursing home-acquired, in people with SCI, PrIs typically develop in the community. Community-acquired pressure injuries (CAPrIs) are common, devastating, and costly. This grant proposal will assess how well a decision support tool, called the Community Acquired Pressure Injury Prevention Field Implementation Tool (CAPP-FIT), is used in the clinic and how well it prevents CAPrIs. The CAPP-FIT will be implemented at seven sites across the country in a staggered fashion. The CAPP-FIT includes: 1) an automated Veteran survey to identify risks, actions, and resources needed to prevent CAPrIs and 2) a companion Provider Report immediately available in the electronic health record listing Veteran responses to survey items with recommended evidence-based provider actions. The Veteran survey can be completed via a secured email on the computer or phone. There are three aims in the proposal: Aim 1 is implementing the CAPP-FIT at the seven geographically diverse VA SCI clinics. After CAPP-FIT implementation, each site will determine how the CAPP-FIT will be maintained in clinical practice to support sustainability. Aim 2 assesses how well the CAPP-FIT prevents CAPrIs and CAPrI-associated hospitalizations and assesses provider and Veteran satisfaction. Aim 3 assesses how well the CAPP-FIT is implemented in the SCI clinic.

Cleveland, OH18+ yrsAll genders
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Understanding and Enhancing Human Health and Movement

Spinal Cord Injury ยท Stroke (CVA) or Transient Ischemic Attack ยท Multiple Sclerosis

By doing this study, investigators hope to learn how electrical stimulation can improve human movement, biomechanics, and function and to gather information on the safety and effectiveness of an implanted electrical stimulation system after paralysis from spinal cord injury, stroke, multiple sclerosis, and traumatic brain injury.

Cleveland, OH18+ yrsAll genders
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At-Home Genital Nerve Stimulation for SCI Bowel

Spinal Cord Injury

The purpose of this study is to test whether electrical stimulation of the skin in the pelvic area (near the genitals) can reduce the reflexes that cause bowel accidents in people with spinal cord injuries. Current bowel treatments either involve diet and medications or surgery. This study will evaluate whether electrical stimulation can be an alternate option for bowel management. Researchers will: * Use an FDA approved Transcutaneous Electrical Nerve Stimulation (TENS) device off-label * Compare a target stimulation level to a placebo stimulation level Participants will: * Use electrical stimulation on the skin in the pelvic area for 6-8 hours each day for 4 weeks at home * Visit the research center 3 times to participate in exams and answer questions * Keep a daily diary of their bowel symptoms and stimulation times

Cleveland, OH18+ yrsAll genders
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A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury

Chronic Spinal Cord Injury

The goal of this clinical trial is to learn if NVG-291 can improve function in adults with chronic cervical motor-incomplete spinal cord injury. It will also learn about the safety of NVG-291. The main questions it aims to answer are: * Does NVG-291 improve hand function and daily activities? * What side effects do participants have when taking NVG-291? Researchers will compare NVG-291 to a placebo (a look-alike substance that does not contain NVG-291) to see if NVG-291 improves function in adults with chronic cervical motor-incomplete spinal cord injury. Participants will: * Take NVG-291 or a placebo by injection under the skin (subcutaneous) once daily for 12 weeks. * Attend clinic visits for checkups and safety tests. * Complete tests and questionnaires about hand function, walking, daily activities, and quality of life. * Take part in an interview about changes in their condition, within 14 days after the Week 12 visit.

Cleveland, OH18โ€“75 yrsAll genders
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Fermented Foods and Bowel Health in SCI

Spinal Cord Injury

The goal of this clinical trial is to learn whether consuming a high fermented food diet improves bowel function and gut health in adults with chronic spinal cord injury (SCI). The study will also evaluate the feasibility and tolerability of consuming fermented foods daily for 10 weeks. The main questions it aims to answer are: 1. Does a high fermented food diet improve neurogenic bowel dysfunction symptoms and colonic transit in adults with SCI? 2. Does fermented food intake change gut microbiome composition, short-chain fatty acid production, and intestinal inflammation? Researchers will compare a high fermented food diet to a control diet to evaluate effects on bowel health and gut microbiome outcomes. Participants will: * Consume study foods daily for 10 weeks * Attend 2 in-person study visits * Collect stool samples at home and ship them overnight to the research team using provided collection kits and prepaid shipping materials * Complete bowel health questionnaires and dietary recalls * Undergo Sitz marker testing with abdominal X-rays to assess colonic transit * Participate in biweekly monitoring contacts throughout the study period

Columbus, OH18โ€“70 yrsAll genders
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Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adults With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization

Neurogenic Detrusor Overactivity ยท Spinal Cord Injuries

This is a first-in-human, Phase 1b/2a, open-label, dose-escalation study of a single treatment course consisting of multiple intradetrusor injections of EG110A in male and female adult participants with Neurogenic Detrusor Overactivity (NDO)-related incontinence following Spinal Cord Injury (SCI), who have persistent incontinence after standard of care therapy and who perform Clear Intermittent Catheterization (CIC) on a regular basis.

Columbus, OH18โ€“75 yrsAll genders
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Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy

Spasticity as Sequela of Stroke ยท Spastic Cerebral Palsy ยท Spasticity, Muscle

A scientific study is being done to test a special treatment for people who have spasticity or tight muscles. This treatment is called "stereotactic radiosurgery dorsal rhizotomy." It uses very accurate beams of radiation to target certain nerves in the back to help loosen up the muscles. In this study, people are put into two groups by chance: one group gets the real treatment, and the other group gets a "fake" treatment that doesn't do anything. This fake treatment is called a "sham." Doing this helps make sure the study is fair and the results are true. After the people in the study get their treatment, the researchers will watch and see how they do. They will check if their muscles are less stiff and if they have any side effects. By looking at the results from both groups, the researchers can find out if the special treatment really helps people with spasticity. Patients who got the "fake" treatment will be eligible to receive the "real" treatment after 6 months.

Columbus, OH16+ yrsAll genders
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A Neuroprosthesis for Seated Posture and Balance

Spinal Cord Injury ยท Paralysis ยท Tetraplegia

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.

Cleveland, OH21+ yrsAll genders
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RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses

Adjustment Disorder

The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.

Cleveland, Columbus, OH18โ€“80 yrsAll genders
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Recruiting

Development of Optimal Sensory Feedback Strategies to Maximize Function After Tetraplegia

Spinal Cord Injury Cervical ยท Spinal Cord Injuries (Complete and Incomplete)

The goal of this clinical trial is to learn more about how stimulating the nerves involved in sensation (either in the limbs or in the brain) can be used to restore sensation in participants who have a spinal cord injury. Participants in this study will have already been enrolled in the "Reconnecting the Hand and Arm to the Brain (ReHAB)" study, and received small electrodes in a part of the brain that is involved in sensing touch and pressure in the hand. The ReHAB study participants will also have received electrodes around the nerves in their arm. In this clinical trial, participants will receive two types of electrical stimulation: * Intracortical microstimulation (ICMS) which involves sending small electrical pulses to the part of the brain that processes sensation. * Peripheral nerve stimulation (PNS) which involves sending small electrical pulses to the nerves in the arm that transmit sensations from the hand. Researchers will try different patterns of stimulation for both ICMS and PNS and study how the participants perceive the sensations from the different stimulation patterns. The researchers will also study how combining ICMS and PNS affects the perceived sensations.

Cleveland, OH22โ€“65 yrsAll genders
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Exciflex Electroceutical Banadage for Chronic Wound Therapy

Chronic Wound ยท Diabetes ยท Spinal Cord Injury

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 Louis Stokes Cleveland VA Medical Center (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.

Cleveland, OH18+ yrsAll genders
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Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury

Fecal Incontinence

Bowel issues occur in nearly all people after spinal cord injury (SCI) and one major complication is fecal incontinence (accidents). This complication has been repeatedly highlighted by people living with SCI as particularly life-limiting and in need of more options for interventions. This study will test the effect of genital nerve stimulation (GNS), with non-invasive electrodes, on the activity of the anus and rectum of persons after SCI. Recording anorectal manometry (ARM) endpoints tells us the function of those tissues and our study design (ARM without stim, ARM with stim, ARM without stim) will allow us to conclude the GNS effect and whether it is likely to reduce fecal incontinence. The study will also collect medical, demographic, and bowel related functional information. The combination of all of these data should help predict who will respond to stimulation, what will happen when stimulation is applied, and if that stimulation is likely to provide an improvement in fecal continence for people living with SCI.

Cleveland, OH18+ yrsAll genders
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