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Showing 1-20 of 143 trials
NCT04894734
The purpose of this feasibility study is to compare the impact of Spinal cord stimulation \[SCS\] for Spinal Cord Injury (SCI) pain and rehabilitation. SCS, also known as Epidural Electrical Stimulation (EES), will be utilized along with conventional medical management (CMM) or CMM alone. Participation in this research study is expected to last approximately 24 months. All subjects will be evaluated and proceed with implantation of two SCS devices- one tailored based on the individual's SCI for the treatment of neuropathic pain of trunk and limb and a second near the bottom of the spinal cord (conus region) to study the impact on motor, sensory, bowel/bladder outcomes. All patients will also continue receiving CMM, such as medications and physical therapy. Participating subjects will be allocated to one of two treatment groups: 1. Placebo arm: SCS OFF + CMM. Under the direction of the study physician, the patient may receive a variety of treatments, such as medications and various forms of rehabilitation. 2. Treatment arm: SCS ON + CMM. The study treatment Spinal Cord Stimulation \[SCS\]: the study physician will perform a trial procedure to see if the study procedure works for the patient and may implant a permanent device if it is successful. There is a temporary trial procedure, or a "test drive," which usually lasts 5-7 days. If this is successful, patients will discuss a more permanent implant. This study involves the concurrent placement of two SCS devices (one focused on pain and the second for rehabilitation). For three months, treatment group subjects will have the SCS turned on and will have rehabilitation as part of their CMM. Participants in the placebo arm will have their SCS remain off and will undergo CMM with rehabilitation therapy similar to the treatment group. Neither the subjects nor the treatment team will know which patients are in the treatment or placebo arm. At the end of three months, the study group will be revealed and the placebo group subjects will be allowed to crossover and have their SCS turned on. Rehabilitation visits may be remote and the study duration is approximately 24 months. There may be additional blood tests and clinical exams to collect data on the effectiveness of the therapy. Data at follow-up visits will be compared to the subjects' baseline data and that of the control group at the respective visits.
NCT07473258
The goal of this clinical trial is to learn if a 10-week web-based health promotion program ("DRIV") can improve healthy lifestyle habits and overall well-being in adults living with long-term spinal cord injury (SCI). The main questions it aims to answer are: Does participating in the online course lead to healthier lifestyle behaviors (for example, more physical activity and a better diet) and improved self-reported health for people with SCI? Are any improvements in health habits or well-being maintained six months after completing the program? Researchers will compare participants who take the 10-week DRIV course to those on a waitlist (no intervention during that period) to see if any changes in lifestyle or health outcomes are due to the program (and not just time or other factors). Participants will: Attend a 1-hour group session online (via video) each week for 10 weeks, covering topics like exercise, nutrition, stress management, and goal setting (this is the intervention for the course group; waitlist group has no sessions during this time). Complete health questionnaires at the start of the study and after 10 weeks (all participants), and again 6 months after the course for those who received the intervention, to report on their lifestyle habits, physical and mental health, and goal achievement. Wear a wrist activity monitor (accelerometer) for 7 days at the beginning and 7 days at the end of the 10-week period to objectively measure physical activity levels.
NCT07280351
The goal of this clinical trial is to learn if a procedure called "expansile duraplasty" can improve recovery in adults who have experienced an acute traumatic spinal cord injury (SCI). The main questions it aims to answer are: * Does expansile duraplasty work to improve recovery in people with acute traumatic SCI? * How safe is the use of expansile duraplasty in people with acute traumatic SCI? Researchers will compare the strength, movement, and overall recovery of participants who receive expansile duraplasty to that of participants who do not receive expansile duraplasty to see if the use of expansile duraplasty leads to better recovery for people with acute traumatic SCI. Participants will be randomly placed in one of two groups: an Experimental group and a Control group. Participants in the Experimental group will receive expansile duraplasty during their standard SCI surgery. Participants in the Control group will not receive expansile duraplasty during their standard SCI surgery. All participants will: * Provide samples of blood and cerebrospinal fluid * Undergo magnetic resonance imaging (MRI) scans * Undergo an assessment of the ability to move arms/legs and feel touch or pin prick * Answer questionnaires about medical history, pain, health, and independence with activities of daily living
NCT06587607
This study involves delivering a mindfulness program that was developed for Veterans called VA Compassionate Awareness Learning Module (VA CALM) to Veterans with spinal cord injuries (SCI) to develop accommodations to make the VA CALM program more accessible for those with SCI. It will involve delivering the unmodified curriculum to a group of Veterans with SCI first to determine what areas need accommodations, working with a group of stakeholders to develop appropriate accommodations, and then delivering 1-2 modified modules via virtual reality to evaluate whether using virtual reality was feasible and acceptable for this program.
NCT07361627
The goal of this RCT study is to evaluate if combining activity-based therapy (ABT) with transcutaneous spinal cord stimulation (tSCS) can improve recovery of arm and hand movement in people with cervical spinal cord injury (SCI). As secondary aims, the study will also investigate at how this combination approach affects the cortical changes in the somatosensory and motor areas of the brain, as well as in the spinal cord and whether it helps participants use their arms more in daily life. The main questions relevant to this study are: 1. Can the combination of ABT + tSCS improve motor and sensory functions of the arms and hands more than ABT alone during the sub-acute stage after SCI? 2. Does ABT + tSCS induce neuroplasticity, that is, changes in the brain and spinal cord activity linked to motor and sensory functions? 3. Do participants who receive ABT + tSCS report greater use of their arms in daily activities compared to those who receive ABT only? In this study, participants will: * Receive either ABT + tSCS or ABT + sham stimulation (a low-intensity current that does not facilitate the movements) * Take part in 20 training sessions over 6-8 weeks (3 times per week, 45 min of active training each). During this, they will perform strengthening, task-based training, and mental imagery exercises with a therapist. * Complete clinical tests and neurophysiological assessments (transspinal electrical stimulation, electroencephalography and transcranial magnetic stimulation) at three time points-- at the start, after training, and one month later to measure recovery and brain activity changes. Researchers will compare the assessment outcomes across the three time points.
NCT07103993
The purpose of this research is to determine the effects of food on cardiovascular and metabolic health in men with and without spinal cord injury (SCI).
NCT07438353
Individuals with chronic cervical spinal cord injury (SCI) and tetraplegia commonly experience persistent impairment in upper limb function, leading to reduced independence and quality of life. Transcutaneous spinal cord stimulation (tSCS) is a non-invasive neuromodulation technique that has demonstrated potential to improve upper limb strength and function when combined with rehabilitation. However, access to tSCS is limited in Singapore due to cost, regulatory barriers, and the need for frequent outpatient therapy. This study evaluates the safety, efficacy, and feasibility of a home-based digital rehabilitation program incorporating tSCS delivered using a commercially available neuromuscular electrical stimulation (NMES) device. Using a prospective, open-label single-case experimental design with multiple baselines across participants, individuals with chronic, non-progressive cervical SCI will receive daily home-based tSCS combined with an mobile application-guided upper limb exercise program. Upper limb function, quality of life, feasibility, and safety outcomes will be assessed longitudinally over a 22-week study period.
NCT07440459
The goal of this observational study is to assess the course of motor and functional gait recovery induced by Lokomat robot-assisted gait rehabilitation in patients with spinal cord injury. The main question it aims to answer is: How does gait motor and functional multilevel recovery progress over time in patients with spinal cord injury? Assessmets will be conducted at four time points: pre-intervention, mid-intervention, post-intervention, and at 1-month follow-up after the completion of robot-assisted gait rehabilitation. Data will be collected at multiple levels, including: * Clinical tests * Three-dimensional gait analysis with kinematic, kinetic, and electromyographic measurements * Maximum isometric strength * Nerve conduction parameters
NCT07430904
Antimicrobial resistance is a major public health concern that worsens healthcare outcomes. Antibiotic resistant organisms occur more often in Veterans with spinal cord injury or disease (SCI/D) given their frequent exposure to antibiotics, recurrent hospitalizations, and common use of urinary catheter devices. Veterans with SCI/D are also at risk for overtreatment with antibiotics when they do not need them, particularly for over-diagnosed urinary tract infections. The investigators plan to create a patient empowerment program with input of Veterans with SCI/D \[and their providers\] to help guide their decisions and next steps when they have a change in bladder symptoms. The program will give Veterans with SCI/D the tools to speak up to their provider and advocate for themselves to avoid receiving unnecessary antibiotics. This program is highly innovative, as it puts Veterans with SCI/D in charge of thoughtful antibiotic use, or antibiotic stewardship.
NCT06611748
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
NCT07293780
The aim of this study is to evaluate the efficacy of rTMS targeting the anterior cingulate cortex, another stimulation site that may be effective in the treatment of neuropathic pain, and to compare it with motor cortex stimulation.
NCT05360719
The objective of this study is to examine the efficacy of an integrated, participant-centered tele-health physical activity program for individuals with SCI on psychological and social factors through a parallel mixed-methods design approach. We will examine changes in psychological (self-efficacy, self-esteem, exercise outcome expectations, depression, positive affect and well-being, quality of life) and social factors (participation and satisfaction with social roles and activities, activity engagement) following participation in an 8-week integrated group tele-exercise health and wellness physical activity program, with retention assessed at 8-weeks following completion (16 weeks from baseline). We will also complete small group interviews with all participants to understand participant experiences of, response to, and recommendations before and following participation in group tele-exercise program. To date, there is extremely limited evidence for the efficacy of psychological and social well-being of remotely delivered community-based exercise to individuals with SCI. A pilot effectiveness trial of a tele-exercise health and wellness program will be conducted using a mixed methods design with a randomized waitlist control group. Quantitative and qualitative data collection is sequential in nature and other data are collected simultaneously. Individuals with SCI (living with injury 12 months or longer) will be recruited based on existing partnerships locally and nationally. To assess limited effectiveness, we aim to enroll 35 individuals with SCI. Recruitment of these participants will stem from the investigator's ongoing community partnership with local and national partners. The tele-exercise health \& wellness program will consist of virtual group class, twice per week, intended to generate physical confidence and strength for individuals living with SCI. Each session will be co-led with by an individual living with SCI.
NCT07419165
This study aims to investigate the correlation between detrusor and bladder wall thickness measured by suprapubic ultrasound and urodynamic parameters in patients with spinal cord injury. By evaluating ultrasonographic measurements alongside urodynamic findings, the study seeks to assess their relationship in a prospective cross-sectional setting.
NCT06489106
The main goal of this pilot study is to find the best ways to use transcutaneous spinal cord stimulation (scTS) to improve hand function in children with spinal cord injuries (SCI). The investigators will start by exploring the best places and strengths for applying scTS on the neck, the added benefits of applying scTS on the lower back (T11-T12), and comparing the effects of using activity based upper extremity training (a control treatment) alone versus combining it with scTS to help children with chronic SCI regain hand function.
NCT06841770
The DOSED clinical study evaluates the safety and utility of a novel delivery device to deliver LCTOPC1, a cell therapy, to the spinal cord of patients with a spinal cord injury (SCI). LCTOPC1 is designed to replace or support cells that are absent or dysfunctional due to traumatic injury, with a goal to help improve the quality of life and restore or augment functional activity in persons suffering from a traumatic cervical or thoracic injuries.
NCT04295538
Acute Spinal Cord Injury (SCI) is a rare injury that leads to permanent neuromotor impairment and sudden disability. Approximately 25,000 people experience cervical SCI in the United States, Europe, and Japan every year. The purpose of this study is to see if elezanumab is safe and assess change in Upper Extremity Motor Score (UEMS) in participants with acute traumatic cervical SCI. Elezanumab is an investigational drug being developed for the treatment of SCI. Elezanumab is a monoclonal antibody, that binds to an inhibitor of neuronal regeneration and neutralizes the inhibitor, thus potentially promoting neuroregeneration. This study is "double-blinded", which means that neither trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Participants 18-75 years of age with a SCI will be enrolled. Approximately 54 participants will be enrolled in the study in approximately 49 sites worldwide. Participants will receive intravenous (IV) doses of elezanumab or placebo within 24 hours of injury and every 4 weeks thereafter through Week 48 for a total of 13 doses. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
NCT07357428
The Connect-One Study is an early feasibility study to obtain preliminary device safety information for the Connexus Brain-Computer Interface (BCI). The Connexus BCI is intended to be used as: (1) an assistive communication device to decode imagined language correlates and speech for patients with impaired communication as a result of severe loss of voluntary motor control; and (2) to provide control of computer devices for individuals with severe loss of voluntary motor control of the upper extremity.
NCT03096197
The overall aim of this project is to assess the effect of combining transcutaneous lumbosacral stimulation (TLS) during Exoskeleton Assisted Walking (EAW) compared to EAW alone without stimulation on walking recovery.
NCT06836739
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
NCT05524103
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ALMB-0166 in patients with acute spinal cord injury.