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Showing 1-20 of 251 trials
NCT06850363
This is a multi-center, observational, single-arm, 6-week home study to evaluate the safety and efficacy of transcutaneous spinal cord stimulation via the ExaStim system for 4 consecutive weeks used in the home setting for individuals with traumatic spinal cord injury. The study consists of a baseline evaluation and 1-week training period (Week 0), a 4-week stimulation period (Weeks 1-4), and a follow-up visit (Week 5), for a total expected duration of participation for each subject of six weeks.
NCT07507331
This observational study aims to evaluate the cross-cultural adaptation and psychometric properties of the Turkish version of the Neurogenic Bladder Symptom Score Short Form (NBSS-SF) in adults with spinal cord injury or multiple sclerosis who have neurogenic lower urinary tract dysfunction. Neurogenic bladder symptoms, such as urinary incontinence, urgency, and difficulties with urine storage or emptying, may negatively affect daily functioning and quality of life. In this study, the validity and reliability of the Turkish NBSS-SF will be examined, and convergent validity will be assessed through its relationship with the King's Health Questionnaire (KHQ) and the Short Form-12 (SF-12). In eligible participants, the scale will be administered again after 7 to 14 days. The aim of the study is to provide a valid and reliable Turkish patient-reported outcome measure for use in clinical practice and research.
NCT07511244
This clinical trial aims to evaluate the safety and efficacy of spinal cord stimulation (SCS) in treating patients with urinary and bowel dysfunction after spinal cord injury (SCI). SCI is a highly disabling condition that can lead to sensory, motor, and autonomic nervous system dysfunction below the injury level. Neurogenic bladder and bowel dysfunction are common sequelae of SCI, seriously affecting patients' quality of life. Currently, clinical treatments can only partially alleviate urinary and bowel dysfunction, and more effective therapeutic approaches are still needed. Existing clinical studies have shown that SCS is gradually being applied to treat neurogenic bladder and bowel dysfunction in SCI patients. SCS can significantly improve urinary efficiency, bladder capacity, compliance, and detrusor pressure in SCI patients, thereby enhancing their quality of life. The main questions this study aims to answer include: 1. Can this protocol help patients restore partial urinary and bowel function? 2. Besides the restoration of partial urinary and bowel function , can the SCS therapy could also help patients to restore the walking function. Patients with urinary and bowel dysfunction more than 6 months after spinal cord injury will undergo epidural spinal stimulation electrode implantation surgery two weeks after functional assessment. Then the parameter optimization and rehabilitation will last for 6 months. The follow-up records and assessments will be conducted monthly at 2, 4, and 6 months after surgery.
NCT06873529
The aim of this study was to investigate the experiences of women with spinal cord injury regarding fertility, contraception and pregnancy.
NCT06440538
The purpose of this study in people living with cervical Spinal Cord Injury (SCI) is to examine the effects of paired neurostimulation (i.e., PCMS) combined with contralateral motor training on inter-limb transfer of ballistic motor and hand dexterity skills.
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
NCT07467382
The purpose of this study is to evaluate the mechanical properties of the Achilles tendon (stiffness, length, volume) and the force production capacities of the gastrocnemius medialis muscle in patients with spastic paresis (post-stroke or incomplete spinal cord injury) compared to healthy subjects, during gait.
NCT04755699
This is an early feasibility trial to determine whether transcutaneous neuromuscular electrical stimulation, with or without transcutaneous spinal cord stimulation, using an investigational neurostimulation device improves functional arm/hand movements in individuals with paralysis or paresis due to a spinal cord injury or stroke and improves functional arm/hand or leg/foot movements in individuals with paralysis or paresis due to other brain or nerve injuries. In this study, eligible individuals that agree to participate will be asked to attend up to 5 study sessions a week for 1 year (depending on participant availability), with each session lasting up to 4 hours. At the first study session, participants will have their demographic information collected, vital signs assessed, and have measurements performed of their limbs and torso, as appropriate. They will also undergo clinical evaluations and tests to assess their current functional movement and sensation capabilities. During subsequent study sessions, participants will undergo many tasks designed to improve functional movements in paralyzed limbs. Specifically, participants will receive neuromuscular electrical stimulation to the limb(s) and/or electrical stimulation to the spinal cord to evoke specified movements. The stimulation parameters and locations on the spinal column and/or limb(s) that evoke specific movements will be noted. The movements will be assessed with visual inspection, electromyography, and/or sensors. The clinical evaluations and tests to assess functional movement and sensation capabilities will be repeated throughout the study and at the last study session to assess for functional improvements compared to the first study session. Upon completion of these study sessions, the individual's participation in the study is considered complete.
NCT07375745
Spinal cord injury (SCI) often results in partial or complete loss of movement. In the subacute phase (\< 6 months), the central nervous system shows increased potential for neuroplasticity, making it more responsive to rehabilitation and external stimulation. Standard care in rehabilitation centers relies on activity-based therapy (ABT), which uses intensive, task-specific training to promote recovery. Although ABT can improve mobility, its effects are often limited due to the nature of SCI and the indirect activation of neural circuits. Recent findings suggest that adding transcutaneous spinal cord stimulation (tSCS) to ABT in chronic SCI (\> 12 months) can enhance lower-limb motor recovery. This study will evaluate whether combining tSCS with gait training is safe and feasible in individuals with subacute SCI and whether it improves lower-limb motor outcomes compared with gait training alone. The investigators hypothesize that pairing gait training with tSCS early after injury will be safe and feasible and that tSCS delivered during gait training will augment leg muscle activation and lead to greater functional improvements. The study will also assess the feasibility, safety and tolerability of implementing this combined intervention in a intensive functional rehabilitation setting.
NCT07452133
Spinal cord injury (SCI) often results in persistent motor deficits that are inadequately addressed by conventional rehabilitation. Transcutaneous spinal cord stimulation (tSCS) is a promising non-invasive neuromodulatory approach that can enhance motor activation and gait performance; however, current tSCS systems rely on static, pre-programmed stimulation parameters that do not adapt to real-time motor output or task demands. This limitation may reduce muscle selectivity and disrupt the spatiotemporal dynamics of spinal network activation required for functional movement. This study aims to develop and evaluate an AI-powered closed-loop multielectrode tSCS system that dynamically adjusts stimulation parameters in real time based on kinematic and surface electromyography (EMG) feedback during walking in individuals with incomplete SCI. The study will compare immediate muscle recruitment and motor performance between conventional static tSCS and dynamic, targeted tSCS guided by real-time physiological signals. The investigators hypothesize that AI-driven closed-loop tSCS will be safe and feasible, and will result in superior muscle activation patterns and improved gait performance compared with static stimulation. Findings from this study will provide foundational evidence for adaptive neuromodulation strategies and support the advancement of next-generation, data-driven spinal cord stimulation technologies for neurorehabilitation in SCI.
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.