Loading clinical trials...
Loading clinical trials...
Showing 1-20 of 371 trials
NCT07543003
Active-NBS is a study to evaluate the muscle development of patients with spinal muscular atrophy (SMA) who are diagnosed at birth. Medicines have become available in the last decade, and many patients are treated very early. Treatments are most effective if used before the patient develops symptoms. However, some patients may show symptoms by the time they receive treatment. This means that even with early diagnosis, they might still develop muscle weakness despite treatment. The investigators want to see when the movements of patients diagnosed at birth differ from normal development. This information will help identify the best time to give additional medicines currently being developed to support the muscle. The investigators will track the progress of up to 60 patients over a maximum of 30 months using wearable technologies which are worn at home. The investigators aim to validate their outcomes for use in this age group. The wearable devices are called Syde and Motor Assessment of an Infant in a Jumpsuit (MAIJU). They will be worn at regular intervals during the study and will not involve extra hospital visits for patients. The study will also recruit up to 30 healthy control participants and follow them for up to 30 months. This will help define normal development with use of the Syde device. Active-NBS will be conducted in the UK and internationally using a federated data model. Collaborative sites will collect harmonised data in accordance with the Active-NBS protocol, with data integration and oversight managed by the University of Oxford. International sites may contact the Oxford study team to establish collaboration.
NCT05866419
The primary objective of the clinical investigation is to demonstrate successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen in subjects with spinal muscular atrophy (SMA). All enrolled subjects will undergo implantation of the investigational device (ThecaFlex DRx™ System) and will be followed for 12 months after receiving the implant. The 12-month data will be used to assess the primary endpoint support a Pre-Market Approval (PMA) application.
NCT02802033
Details regarding the degenerative spine disorders will be collected with a specific focus on the use of osteobiologics in treating degenerative conditions and their impact on fusion, as well as patient-reported outcomes for these conditions.
NCT05204017
CAPTURE ALS is a long-term data and biorepository platform that will facilitate future ALS research. CAPTURE ALS will provide the standardized systems and tools necessary to collect, store, and analyze vast amounts of multimodal information about ALS. These multimodal datasets and biosamples will be made available for use by researchers or industry across Canada and around the world in accordance with the CAPTURE ALS Data Sharing Policy to advance research on ALS.
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.
NCT06839469
The purpose of this research is (1) to identify disease specific walking-related digital biomarkers of disease severity, and (2) monitor longitudinal changes in natural environments, for extended periods of time, in DMD and SMA.
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.
NCT07502612
This pilot study investigates the effects of reducing pain medication including opioids and anticonvulsants, on spinal cord sensitivity during closed-loop spinal cord stimulation (SCS). Patients with Persistent Spinal Pain Syndrome Type 2 (FBSS/FNSS) will undergo a standard 21-day SCS trial with the Evoke closed-loop system, followed by permanent implantation if successful. Neurophysiological responses (activation plots, conduction velocity, chronaxie, rheobase) and patient-reported outcomes (VAS, activity, sleep, medication intake) will be collected during the trial and up to 6 months after implantation. The goal is to evaluate the relationship between medication tapering and spinal cord sensitivity
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.
NCT04992572
Explore efficacy, complications, and other factors associated with anaesthetic choice- To evaluate the efficacy of local + MAC as an alternative anesthetic to general anesthesia and to analyze patients' outcomes and experiences.
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.
NCT07469020
The goal of this interventional study is to evaluate the rate of existing lower limb peripheral artery disease (PAD) in patients with surgically lumbar spinal stenosis (LSS). PAD and LSS can present similar symptoms and it can be difficult to diagnose PAD using conventional methods, depending on the location of the arterial disease. The main questions it aims to answer are : * What's the prevalence of PAD in LSS patients? * Which exam among routine tools is the most accurate to diagnose PAD in this population? Around their surgery for LSS (a few weeks before or after), participants will be included in a vascular medicine service. After checking of eligibility criteria, they will undergo a contrast-enhanced CT scan for the diagnosis of PAD and various routine diagnostic tests: Doppler ultrasound, treadmill tests, pressure index, pulse palpation.
NCT05115110
Risdiplam works by helping the body produce more survival motor neuron (SMN) protein throughout the body. This means fewer motor neurons - nerve cells that pass impulses from nerves to muscles to cause movement - are lost, which may improve how well muscles work in people with SMA. RO7204239 is an investigational anti-myostatin antibody that is designed to target myostatin. Myostatin plays an important role in the regulation of skeletal muscle size by controlling growth. Inhibiting myostatin may help muscles grow in size and strength. RO7204239 in combination with risdiplam, which is designed to increase the amount of SMN protein throughout the body, has the potential to further improve motor function and clinical outcomes for people living with SMA. This trial will study the safety and efficacy of RO7204239 in combination with risdiplam in patients with spinal muscular atrophy (SMA). The trial has two parts; Part 1 is the dose-finding part in SMA patients that are either ambulant (aged 2-10 years) or non-ambulant (aged 5-10 years) within separate cohorts, and Part 2 is the pivotal part in SMA patients aged 2-25 years that are ambulant.
NCT04944940
Background: SBMA is an inherited chronic disease. It affects males in mid to late adulthood. It causes slowly progressive weakness of muscles and hand tremors. Researchers want to learn more about the effects of SBMA. Objective: To identify measurements that change over time in SBMA, including tests of muscle strength and function, as well as measurements of muscle and fat size. Eligibility: Men over the age of 18 both with and without a history of SBMA. Design: Participants will have a medical history, physical exam, and blood and urine tests. They will have neuromuscular ultrasound. They will have a lumbar puncture to obtain spinal fluid. For this, a needle will be inserted into the spinal canal in the lower back. Participants will have muscle strength and function tests. These tests may include pushing, pulling, rising from a chair and sitting back down, and/or walking. During these tests, they may wear an accelerometer (activity tracker) on their wrist. Participants will get an activity tracker to wear on their wrist for 10 days at home every 3 months. Participants with SBMA will also have lower limb magnetic resonance imaging (MRI) and optional whole-body MRI. They will have lung function tests. They will have speech and swallow tests. They will complete questionnaires. They may have optional body scans to measure bone density and lean body mass. They may have optional muscle biopsies. For biopsies, a needle will be used to take a small piece of muscle from the leg. Participants with SBMA will have 5 study visits over 2 years (every 6 months). Participants without SBMA will have 1 study visit.
NCT05808764
This study will evaluate the pharmacokinetics (PK) and safety of risdiplam in participants with spinal muscular atrophy (SMA) under 20 days of age at first dose.
NCT05861986
This is an open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam administered as an early intervention in pediatric participants with spinal muscular atrophy (SMA) and 2 SMN2 copies who have previously received onasemnogene abeparvovec. Participants are children \< 2 years of age genetically diagnosed with SMA.
NCT04192591
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
NCT00385086
TNF-alpha is the main cytokine implicated in the formation of lumbar spinal fibrosis. Inhibiting TNF-alpha could significantly decrease spinal fibrosis after lumbar discectomy.
NCT07444476
In this study, researchers will learn more about the effects and safety of BIIB115, also known as salanersen. Specifically, researchers will learn more about how salanersen works in individuals with SMA who are between the ages of 15 and 60 years old. In most people living with SMA, changes to or a lack of a gene called survival motor neuron 1 (SMN1) - often referred to as gene mutations or variants - affect how this gene works. As a result, their bodies produce less SMN protein. Without enough of this protein, motor neurons and muscles cannot work properly. There is a similar gene called SMN2 that produces SMN protein, but it usually does not produce enough SMN protein on its own to make up for the changes in the SMN1 gene. Salanersen is a drug designed to help the SMN2 gene to make more working SMN protein. In this study, there will be 2 groups of participants: a group who has never received treatment for SMA before joining this study, and a group who has been treated with risdiplam, an approved drug for SMA . Those participants must not have received any other SMA treatments before and will need to stop their risdiplam treatment for the duration of the study. The main goal of this study is to learn more about how salanersen affects the participants' motor function. Researchers will use different tests and questionnaires to learn if motor function is changing over the study duration. The main question researchers want to answer in this study is: • For the group who has never been treated for SMA, how much do scores on the HFMSE movement test change at 12 months compared to the beginning of the study? The Hammersmith Functional Motor Scale - Expanded (HFMSE) has 33 activities that are scored which include sitting, lying down, walking, jumping, and more. Researchers will also learn more about: * The effects on participants' motor function and how well their nerves and muscles function. * The effects on participants' overall sense of change and how they perform daily activities. * How many participants have adverse events or serious adverse events. Adverse events are health problems that may or may not be caused by the study drug. * How much salanersen gets into the fluid surrounding the brain and spinal cord. * How much salanersen gets into the blood. This study will be done as follows: * First, participants will be screened to check if they can join the study. The screening period may be up to 4 weeks. * This is an "open-label" study. This is a study in which the participants, study doctor, and site staff will know that participants are receiving salanersen. * All participants will receive salanersen through an intrathecal injection, or one that is given into the fluid surrounding the brain and spinal cord. * Participants will receive salanersen once every year for a total of 5 times throughout the study. * Including screening, participants will have 17 study visits and 9 telephone calls during this study, which will last up to 61 months in total.
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).