TTrialPathMatch Me to Trials
โ† All conditions

Spinal Cord & Bladder Trials

Studies for spinal cord injury and related bladder conditions. 394 recruiting now nationwide.

Recruiting

Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)

Spinal Cord Injuries ยท Spine Disease

This randomized clinical trial will compare three groups of individuals with cervical/thoracic, complete or incomplete spinal cord injury (SCI) that will undergo: (i) early CPAP therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs) among adults at 6 weeks after SCI; (ii) delayed CPAP therapy in the management of moderate-to-severe SRBDs among adults at 22 weeks after SCI; and (iii) no treatment as they either have mild or no SRBD.

Toronto18+ yrsAll genders
See details & check eligibility
Recruiting

Tele-Exercise to Promote Empowered Movement in Individuals With Spinal Cord Injury

Spinal Cord Injury

To achieve our specific aims and hypotheses we will conduct a parallel group mixed methods randomized control trial comparing participation in the TEEMS program with exercise via asynchronous video library equivalent (control). The use of mixed methods will allow for the integration of quantitative findings with the qualitative, lived perspective of participants to provide a comprehensive analysis of the tele-exercise program outcomes. All aspects of the study from recruitment, screening, data collection, tele-exercise delivery and team meetings will be virtual to promote access and inclusion by removing barriers and promoting engagement. This study will compare our live group TEEMS program with individual pre-recorded exercise videos. We created TEEMS with the intention of maximizing exercise independence for participants, which decreases need for caregivers during physical activity. The design and participation in TEEMS is meant to increase personal factors that facilitate participation in exercise. These personal factors include confidence and positive associations with exercise. When these personal factors are targeted, individuals with SCI are more likely to participate in physical activity, which supports overall health and QoL.

Philadelphia, PA18โ€“75 yrsAll genders
See details & check eligibility
Recruiting

Effectiveness of a Powered Exoskeleton Combined With FES for Patients With Chronic SCI: a RCT

Spinal Cord Injuries ยท Gait Disorders, Neurologic

While there are a number of prospective studies evaluating powered exoskeletons in SCI patients, to date, not a single well-designed, randomized clinical trial has been published. However, there is evidence for beneficial effects of over-ground exoskeleton therapy on walking function post-intervention from a meta-analysis on non-randomized, uncontrolled studies. Functional electrical stimulation (FES), on the other hand, is a common and established method for the rehabilitation of persons with SCI and has been demonstrated to be beneficial in, e.g., improving muscle force, power output and endurance. Combining FES and overground robotic therapy within the same therapy session could potentially merge and potentiate the effects of each separate treatment, making it a very powerful and efficient therapy method. Up to date, however, comparative studies evaluating benefits of this combined approach (i.e., powered exoskeleton and FES) to robotic therapy without FES are missing.

Nottwil18+ yrsAll genders
See details & check eligibility
Recruiting

Operant Conditioning of Spinal Reflexes Training System--Reflex Operant Down Conditioning

Spinal Cord Injuries ยท Neurological Injury ยท Paralysis

The purpose of this study is to validate the capacity of a reflex training system to change the size of the targeted reflex. For this, the researchers are recruiting 25 individuals with chronic incomplete SCI who have spasticity in the leg to participate in the reflex training procedure. The study involves approximately 45 visits with a total study duration of about 6 months.

Charleston, SC18+ yrsAll genders
See details & check eligibility
Recruiting

Transcutaneous Spinal Cord Stimulation With Robotic Gait Training in Chronic SCI

Spinal Cord Injury

This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment robotic gait training (RGT) to improve functional mobility in participants with chronic spinal cord injuries. It also evaluate the impact of the tSCS+RGT on health-related quality of life (HRQOL), compared to RGT alone. This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 subjects with paraplegia and 6 subjects with tetraplegia will be recruited. The intervention includes Phase 1 of training which consists of 16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks, and Phase 2 of training which consists of 16 sessions of RGT training + tSCS + conventional physiotherapy in 8-10 weeks. Outcome measures including mobility function assessment and neuromuscular assessment will be collected at Baseline, Post-Phase 1 and Post-Phase 2. A satisfaction survey on the intervention "RGT training + tSCS + conventional physiotherapy" will be performed at week-18 assessment.

Singapore21โ€“65 yrsAll genders
See details & check eligibility
Recruiting

Assessment of the Efficacy and Safety of EESS in Patients With Incomplete Spinal Cord Injuries

Spinal Cord Injuries

Neurological disability caused by traumatic lesions of the spinal cord is a significant challenge for medicine and society. These lesions, leading to sublesional central nervous system dysfunction, include sensorimotor, vesico-sphincter and genito-sexual disorders. To date, there is no treatment that enables spinal cord function to be restored. Preclinical studies have been able to demonstrate the recovery of locomotor activity with a combination of locomotor training, pharmacological intervention and epidural electrical stimulation of the lumbosacral spinal cord (EESS) in adult rats with spinal cord transection. An American team have recently been able to show that EESS, combined with locomotor training, caused neurological improvement in four paraplegic patients, with electromyographic muscular activation patterns similar to those observed during walking. In fact, these authors also showed an improvement, under stimulation, of the VS and GS functions, but with no detailed documentation. Starting with a conceptual and preclinical rationale, and with proof of clinical concept demonstrated in several reported cases, we propose a clinical trial with an original cross-over design to validate the hypothesis that EESS combined with training in patients with incomplete spinal cord injuries would, with a good tolerance profile, allow motor, vesico-sphincter (VS) and genito-sexual (GS) disorders to be restored in patients with incomplete spinal cord injuries.

Multiple locations18โ€“65 yrsAll genders
See details & check eligibility
Recruiting

Spinal Stimulation for Upper Extremity Recovery in the Home

Cervical Spinal Cord Injury

The purpose of this research is to evaluate the safety, feasibility, and tolerability of non-invasive spinal stimulation used in the home and/or community in combination with a functional home exercise program for the upper extremities (arm/hand function) as well as their combined impacts on changes in upper extremity function. The expected duration of participation in this study is about 31-33 hours over a 13-25-week period. Enrollees in this study will be randomly assigned to one of two groups: 1) upper extremity functional task-specific training combined with non-invasive transcutaneous spinal stimulation, or 2) waitlist control, which involves the same intervention, but with a 12-week delayed start. Participants complete initial testing (one time if in group one and three times \[at weeks 0, 8, and 12\] if in group two), 24 1-hour training sessions (2x/week in home with caregiver/companion support and 1x/week with research team in person or via video conference for 8 weeks), a post-treatment evaluation, and a final evaluation (4 weeks after post-treatment).

Englewood, CO18+ yrsAll genders
See details & check eligibility
Recruiting

Duroplasty for Injured Cervical Spinal Cord With Uncontrolled Swelling

Spinal Cord Injuries

QUESTION. Does duroplasty improve outcome after spinal cord injury? WHAT DO WE STUDY? We will investigate whether performing a surgical procedure called duroplasty improves outcomes after spinal cord injury. WHY SPINAL CORD INJURY? Spinal cord injury is a devastating condition that causes permanent disability such as paralysis, numbness and loss of bladder and bowel control. Currently, there are no treatments shown to improve outcome after spinal cord injury. WHAT IS DUROPLASTY? Duroplasty is an operation that involves opening the tough membrane around the cord, called the dura, and stitching a patch of artificial dura to expand the space around the swollen cord. WHY IS DUROPLASTY BEING STUDIED? Based on our preliminary evidence, we think that the dura causes cord pressure after injury. We have shown in a small study of patients that performing this operation safely and effectively reduces pressure on the injured cord. WHO IS ELIGIBLE? Adult patients with severe spinal cord injuries in the neck who will have surgery within 72 hours. WHAT TREATMENT? Those who agree to take part will be allocated by chance (like tossing a coin) to standard treatment or standard treatment plus duroplasty. Some patients will also be asked to take part in a smaller study that involves placing probes at the injury site. WHERE? Initially, we will recruit patients from U.K. Major Trauma Centres. Most assessments will be done in U.K. Spinal Injury Centres. Later on, we we also started recruiting from overseas. HOW LONG? We aim to recruit 222 - 260 patients over 4 years. Patients will be followed up for a year. WHAT DO WE ASSESS? Patients will be assessed (using questionnaires and by examination) how well they can use their hands, walk, control their bladder and bowel and their quality of life. Some of these assessments will be repeated at 3, 6 and 12 months after surgery. WHAT IS THE OPTIONAL MECHANISTIC STUDY? DISCUS includes an optional study for at least 50 patients who will take part in the randomised controlled trial. The aim of the mechanistic study is to determine how duroplasty improves outcome, i.e. whether duroplasty reduces cord compression, improves blood flow to the injured cord perfusion, improves cord metabolism and reduces cord inflammation. WHAT IS THE OPTIONAL INFORMATION STUDY? For the first two years, a study called QuinteT Recruitment Intervention (QRI) is designed to optimise patient recruitment and informed consent in the trauma setting.

Wuhan16+ yrsAll genders
See details & check eligibility
Recruiting

Epidural Electrical Stimulation to Restore Standing and Walking in Patients With Chronic Paralysis Due to Spinal Cord Injury: A Study on Motor Recovery, Spasticity Reduction, and Quality of Life Improvement Through Neuromodulation and Intensive Rehabilitation

Spinal Cord Injuries (SCI) ยท Paralysis, Lower Limbs

Spinal cord injury (SCI) is a major cause of morbidity and disability worldwide, significantly impacting patients' quality of life and functional independence. Despite advances in rehabilitation therapies, many individuals with SCI remain unable to stand or walk. Epidural electrical stimulation (EES) has emerged as a promising neuromodulation therapy to restore motor function in individuals with chronic paralysis. This prospective clinical study aims to evaluate the efficacy and safety of EES in patients with chronic SCI who have lost the ability to stand or walk. The primary objective is to assess late-stage gait recovery following the implantation of an epidural spinal cord stimulator, using validated clinical scales such as the Fugl-Meyer Assessment - Lower Extremity (FMA-LE) and BMCA VRI. Secondary objectives include evaluating: The ability to stand independently (measured by the Berg Balance Scale). Improvements in walking capacity, with or without assistance. Changes in spasticity induced by EES (Modified Ashworth Scale). Reduction in pain perception (DN4, Brief Pain Inventory \[BPI\], Pain Disability Index \[PDI\]). Improvements in neurogenic bladder and bowel dysfunction (NBSS and NBDS). Enhancements in quality of life (SCI-QOL, WHOQOL-BREF) and mood (Beck Depression Inventory \[BDI\]). The study will recruit 10 adult patients (ages 18-50) with chronic, stable SCI (โ‰ฅ6 months post-injury) classified as ASIA A or B, with lesions between C7 and T10 and intact segmental reflexes below the injury level. Participants will undergo an intensive 3-month pre-implant rehabilitation program to maximize their baseline motor potential. Following this period, eligible patients will receive surgical implantation of an epidural spinal cord stimulator (Medtronic Specify 5-6-5 paddle lead and Intellis pulse generator). After a 1-month post-surgical recovery period, patients will engage in a 12-month intensive rehabilitation protocol (5 supervised sessions per week), with the stimulator activated to facilitate motor recovery. Patients will be assessed monthly through clinical evaluations and surface electromyography (EMG) to measure motor control improvements. Outcomes will be compared before and after EES implantation to determine the effectiveness of the intervention. This study seeks to provide further evidence on the potential of epidural electrical stimulation in restoring standing and walking abilities in individuals with SCI. If successful, it could contribute to expanding treatment options for patients with chronic paralysis.

Sรฃo Paulo18โ€“50 yrsAll genders
See details & check eligibility
Recruiting

Comparing the Ceriter Stride One, a Pressure-sensitive Smart Insole, With Gait Parameters Measured on the GRAIL in Neurological Populations

Stroke ยท Incomplete Spinal Cord Injury ยท Traumatic Brain Injury

Ceriter Stride-One soles have been available on the market for several years. One of the features of these soles is that they can measure gait parameters while patients walk around in a functional environment. This can provide a more realistic picture of gait patterns compared to measurements taken in a laboratory setting. At UZ Ghent, we use an advanced gait lab to measure gait parameters before and after a training period on this system, the GRAIL system. We measure similar parameters to the Ceriter Stride-One soles (support phase, swing phase, pressure on the left leg and on the right leg). In this study, we would apply these insoles to patients who are tested on the GRAIL system, according to standard care, during the test in order to compare the parameters measured by the insoles and the parameters measured by the GRAIL system. This information will give us more insight into the accuracy of the data measured with these soles so that we can apply them in future studies conducted not in the gait lab but in functional environments. Patients who are eligible for GRAIL therapy and are therefore routinely tested are patients who are admitted or undergoing outpatient rehabilitation at the rehabilitation centre of UZ Ghent after a brain injury, stroke, spinal cord injury or amputation. Given the subject of the research and the difficulty of fitting a sole into the shoe of a prosthetic leg, only people with brain and spinal cord injuries are asked to participate in the study. Participants must be able to step onto the GRAIL treadmill with the help of one therapist and must be able to walk for at least six minutes. Participants have to weigh less than 120 kg (treadmill safety system restriction). As standard in our setting, participants train for 5 weeks, twice a week for 30 minutes on the GRAIL treadmill. Before and after their training period, they walk on the GRAIL for about 2 minutes and we measure a number of gait parameters: speed, step width, step length, duration of the support phase and swing phase, and how much they support on their left and right legs. Some of these parameters can also be measured by the Ceriter Stride One sole. The aim is to investigate how comparable these data are. If these data are sufficiently comparable, the soles can be used to measure the ratio of the support and swing phases during walking in everyday tasks or in environments other than a laboratory setting.

Multiple locationsAll agesAll genders
See details & check eligibility
Recruiting

Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia

Spinal Cord Injury

In support of the long-term goal of developing new strategies to increase limb function after SCI, the objectives of this proposal are to: 1) Examine the behavioral and physiological effects of TESS on upper-limb muscles after cervical SCI; and 2) Maximize the recovery of reaching and grasping potential by using tailored TESS in a task-specific manner with motor training. Veterans with cervical spinal injuries and healthy volunteers will be recruited for this study.

Chicago, IL18โ€“70 yrsAll genders
See details & check eligibility
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
See details & check eligibility
Recruiting

The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study

Spinal Cord Injury

To determine the accuracy of serum NF-L and GFAP levels (ie the biomarkers) at different time points postinjury for predicting the severity of neurologic impairment at 6 months postinjury as either motor complete (AIS grade A/B) or motor incomplete (AIS grade C/D) a group of patients who suffer traumatic spinal fracture and/or dislocation of the spinal column but without neurologic injury will be enrolled as non-SCI spine trauma control participants.

Milwaukee, WI19+ yrsAll genders
See details & check eligibility
Recruiting

Turkish Translation and Content Validity of the Nottwil Environmental Factors Inventory (NEFI) in Persons With Spinal Cord Injury

Spinal Cord Injuries (SCI)

This observational methodology study will produce a Turkish version of the Nottwil Environmental Factors Inventory (NEFI-TR) within one month using a standardized translation and cultural adaptation process. Content validity will be assessed using an expert panel (and, if applicable, cognitive debriefing with adults with spinal cord injury) to ensure relevance, clarity, and comprehensibility of each item in the Turkish context.

Multiple locations16+ yrsAll genders
See details & check eligibility
Recruiting

Cardiac Morphology and Function in Individuals With Autonomic Dysreflexia

Autonomic Dysreflexia ยท Spinal Cord Injuries and Disorders (SCI/D) ยท Cardiac Remodeling

This case-control study aims to investigate left ventricular remodeling in individuals with chronic spinal cord injury or disease (SCI/D) (โ‰ฅ10 years) and autonomic dysreflexia (AD) who have no prior cardiovascular history. The primary objective is to compare cardiac changes between 24 individuals with high-level SCI/D (above Th6) who have AD and 24 individuals with low-level SCI/D (below Th10) who do not have AD. A secondary objective examines how factors such as age, sex, injury duration, and physical activity are associated with cardiac remodeling. All 48 participants will undergo cardiac MRI as well as blood measurement of B-type natriuretic peptid to assess cardiac morphology and function. The findings could shed light on a potentially underestimated cardiovascular risk factor in the SCI/D population.

Multiple locations18+ yrsAll genders
See details & check eligibility
Recruiting

Using Smartphones to Improve Physical Activity Levels of Individuals With Spinal Cord Injury

Spinal Cord Injuries

The overarching goal of this research study is to evaluate a sensor-enabled, just-in-time adaptive intervention (JITAI) strategy to increase and sustain physical activity levels among individuals with spinal cord injury (SCI) in their communities. A primary objective of this study is to evaluate the integration of a JITAI with a web-based physical activity intervention program. We hypothesize that the integration of web-based physical activity intervention program with JITAI will result in significantly higher physical activity levels compared to the standard web-based physical activity intervention program alone. A secondary objective of this study is to extend existing algorithms that use commercial wearable technology to robustly detect physical activity behaviors to facilitate the delivery of tailored just-in-time actionable feedback and physical activity recommendations for individuals with SCI.

Philadelphia, PA18โ€“75 yrsAll genders
See details & check eligibility

Spinal Cord & Bladder trials by state