150 Clinical Trials for Various Conditions
Researchers in this study want to find the appropriate dose of drug BAY1747846 for adults undergoing MRI for known or highly suspected brain and/or spinal cord conditions so that the image quality is similar to that of drug gadobutrol for adults undergoing MRI. MRI stands for Magnetic resonance imaging which produces body pictures created by using magnetic energy rather than x-ray energy. Both BAY1747846 and gadobutrol are medicinal products known as gadolinium-based contrast agents (GBCA) which are used in MRI examinations to provide contrast enhancement and improve imaging performance. Gadobutrol (brand name: Gadavist, Gadovist) has been approved worldwide for the diagnosis of various disorders in adult and pediatric patients. BAY1747846 is a new GBCA under development with the goal to provide similar imaging performances in MRI. Participants in this study will receive both BAY1747846 and gadobutrol with a period of 3 - 14 days in between. A MRI examination will be performed after each injection. Participant will stay in this study for 2 - 4 weeks depending on the scheduling of the visits.
Central Nervous System Pathology
Over one million Americans rely on their upper extremities for manual wheelchair propulsion. Shoulder overuse injuries are prevalent among manual wheelchair users and these injuries often result in shoulder pain. Severe shoulder pain can lead some wheelchair users to transition from manual to powered mobility, complicating transportation, and reducing independence in activities of daily living. This project will expand the understanding of a new wheelchair design that allows better positioning of the hand rims and allows for different gearing. The investigators will study steady-state propulsion efficiency with different gear ratios and develop a new system with multiple gear ratios. The advanced gearing will allow for a low gear when initiating movement, going uphill, or when moving over carpet, and then a higher gear option for movements on hard flat level terrain. This system has the potential to dramatically improve shoulder ergonomics and reduce pain in many future manual wheelchair users.
Spinal Cord Diseases, Spinal Cord Injuries
This is a multi-center, prospective, blinded, pilot feasibility study to evaluate improvement in sensory and motor function with sham.
Spinal Cord Diseases
This investigation will assess how the timing and type of rehabilitation after a transforaminal lumbar interbody fusion will affect the efficacy of the surgical procedure. The efficacy of the procedure will be evaluated through patients' quality of life, measured by health-related quality of life questionnaires up to 24 months following the procedure. These measures will be compared to the patients' baseline value.
Degenerative Spinal Cord Disease
The objective of this study is to compare the clinical and radiographic outcomes of multi-level laminectomy to multi-level laminoplasty in the treatment of patients with cervical myelopathy or myeloradiculopathy. The hypothesis for the study is that the laminoplasty group is not inferior to the laminectomy group.
Spinal Cord Diseases
Individuals who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and/or weakness of their arms and hand muscles. This project aims to test the effects of pairing spinal cord and nerve stimulation combined with physical therapy training in recovering arms and hand function. The long-term goal is to provide better therapies that will improve the ability of individuals with spinal cord injuries to use their arms and hands to perform everyday tasks, similar to injury before.
Spinal Cord Injury, Spinal Cord Disease, Spinal Cord Injuries (SCI)
The objectives of this study are to (1) determine the effects of neuromodulation techniques on mobility in persons with chronic SCI, as measured by subjective and objective measures, and (2) to determine the optimal combination of techniques that modify mobility and movement in an individual. The neuromodulation techniques explored will be methods of electromagnetic stimulation - that is, electrical stimulation and magnetic stimulation.
Spinal Cord Injuries, Spinal Cord Diseases
So far, therapies have limited success in functional recovery in adults with chronic SCI. By introducing remote cognitive multisensory rehabilitation (CMR), which has shown significant functional improvements due to neurological recovery when delivered in-person, transformative results that (i) provide a potentially effective new therapy within the healthcare system, accessible to more patients, and (ii) demonstrate brain function changes alongside improved function in chronic SCI are anticipated. The results will inform and justify a large scale federally funded clinical trial.
Spinal Cord Injuries, Spinal Cord Diseases
The goal of this clinical trial is to evaluate the effect of transcutaneous spinal cord stimulation on blood pressure in individuals with an acute spinal cord injury (within 30 days of injury). Blood pressure instability, specifically orthostatic hypotension (a drop in blood pressure when moving lying flat on your back to an upright position), appears early after the injury and often significantly interferes with participation in the critical rehabilitation time period. The main questions it aims to answer are: 1. Can optimal spinal stimulation increase blood pressure and resolve orthostatic symptoms (such as dizziness and nausea) when individuals undergo an orthostatic provocation (a sit-up test)? Optimal stimulation and sham stimulation (which is similar to a placebo treatment) will be compared. 2. What are the various spinal sites and stimulation parameters that can be used to increase and stabilize blood pressure to the normal range of 110-120 mmHg? Participants will undergo orthostatic tests (lying on a bed that starts out flat and then moved into an upright seated position by raising the head of bed by 90° and dropping the base of the bed by 90° from the knee) with optimal and sham stimulation, and their blood pressure measurements will be evaluated and compared.
Spinal Cord Injuries, Spinal Cord Diseases, Trauma, Nervous System, Nervous System Diseases, Central Nervous System Diseases, Hypotension, Orthostatic Hypotension, Cardiovascular Diseases, Acute Spinal Cord Injury, Blood Pressure
This project will investigate the effect of spinal cord transcutaneous stimulation on blood pressure in individuals with a chronic spinal cord injury who experience blood pressure instability, specifically, orthostatic hypotension (a drop in blood pressure when moving from lying flat on your back to an upright position). The main questions it aims to answer are: 1. What are the various spinal sites and stimulation parameters that normalize and stabilize blood pressure during an orthostatic provocation (70 degrees tilt)? 2. Does training, i.e., exposure to repeated stimulation sessions, have an effect on blood pressure stability? Participants will undergo orthostatic tests (lying on a table that starts out flat, then tilts upward up to 70 degrees), with and without stimulation, and changes in their blood pressure will be evaluated.
Spinal Cord Injuries, Hypotension, Orthostatic Hypotension, Spinal Cord Diseases, Cardiovascular Diseases, Trauma, Nervous System, Central Nervous System Diseases, Nervous System Diseases, Blood Pressure
The goal of this study is to evaluate if non-invasive electrical spinal stimulation can help people with paralysis caused by SCI improve strength and function of their arms, legs, hands or feet. The study will involve therapy sessions involving exercises done at the same time as electrical stimulation therapy. This study has multiple parts to evaluate the effectiveness and safety of "smart" electrical stimulation of the spinal cord, which involves stimulating the spinal cord at precise locations and times to improve movement and function.
Spinal Cord Injuries, Spinal Cord Diseases
The proposed project seeks to maximize the functional recovery achieved during the rehabilitation of the paretic upper limbs in individuals with SCI. The investigation will work towards optimizing the use of transcranial direct current stimulation (tDCS), an adjunct known to improve the effectiveness of rehabilitation. In particular, the relationship between the specificity of current delivery and functional benefit will be explored, and findings may lead to a framework that can be translated to the clinic setting.
Spinal Cord Injuries, Spinal Cord Diseases
Spinal cord injury following posterior decompression in patients suffering from chronic, cervicothoracic spinal cord compression is a known complication with multiple etiologies. Currently, intraoperative neuromonitoring (IONM) remains the gold standard for predicting and preventing post-operative deficits from these procedures. However, there is a paucity in the field of spine surgery for further, non-invasive biomarkers that can help detect and prognosticate the degree of spinal cord injury intraoperatively. Contrast enhanced ultrasound (CEUS) is a radiation free imaging modality that utilizes nanobubble technology to allow for visualization of the macro- and microvascular architecture of soft tissue structures. Despite being currently approved for the use in hepatology and cardiology, it has remained absent from the field of spinal cord injury. The study team aims to evaluate and quantify micro- and macrovascular changes that lead to areas of hyper-perfusion as well as areas of ischemia intraoperatively in patients that undergo elective cervicothoracic posterior decompression for chronic compression. In addition, the study team aims to assess the efficacy of CEUS in detecting microvascular changes that correlate with IONM changes and predicting degree and recovery of post-operative neurologic deficits from intraoperative spinal cord injury. The study team hypothesizes that following decompression, subjects will have detectable levels of microvascular changes causing areas of hypoperfusion and reperfusion injury. Second, the study team hypothesizes that these perfusion changes will correlate with intraoperative neuromonitoring changes and can predict and prognosticate the degree of post-operative neurologic injury.
Spine Disease, Spinal Stenosis, Spinal Injury, Spinal Cord Diseases, Spinal Cord Injuries, Spinal Cord Compression, Spine Degeneration
The purpose of this research is to combine two complementary modes of treatment, spinal interstitial laser ablation and stereotactic spine radiosurgery (SSRS) for the treatment for spinal tumors near the spinal cord with an objective to improve tumor control, improve pain control, preserve function, and improve quality of life. We will also assess how effective these combined modes of treatment are in patients with spinal metastasis with an epidural component.
Neoplasm Metastasis, Spinal Cord Diseases, Spinal Cord Compression, Spinal Cord Tumor, Spine Metastases
The purpose of this research study is to compare the effect of two different types of education and support programs for partner caregivers of people with spinal cord injury (SCI).
Spinal Cord Injuries, Spinal Cord Diseases
This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.
Spinal Cord Injury, Spinal Cord Injuries, Trauma, Nervous System, Wounds and Injury, Central Nervous System Diseases, Spinal Cord Diseases, Gonadal Disorders, Endocrine System Diseases, Hypogonadism, Genital Diseases, Male, Spinal Cord Trauma, Injuries, Spinal Cord, Walking, Difficulty, Gait Disorders, Neurologic, Locomotion Disorder, Neurologic, Wounds and Injuries, Nervous System Diseases, Testosterone Deficiency, Androgen Deficiency, Hormone Deficiency
Incomplete spinal cord injuries (SCI) are the most frequent neurologic category, comprising 66.7% of all SCI cases. People with incomplete SCI may retain some ability to move the legs and therefore the capacity to regain walking. Studies that show functional improvement in locomotion via electrical stimulation of lumbosacral circuits suggest that the underlying mechanisms are neuromodulation of lumbosacral spinal cord automaticity and sensory feedback. Both epidural and transcutaneous spinal stimulation are demonstrating exciting potential to improve limb function for people after chronic SCI. Available treatment options for SCI are less than satisfactory and most often do not achieve full restoration of function. Recent experimental results suggest an exciting new approach of using electrical spinal stimulation to enable users to regain control of their weak or paralyzed muscles. Using surgically-implanted electrodes, epidural stimulation results in remarkable improvements of lower extremity function as well as autonomic functions such as bladder function and sexual function. In addition to epidural stimulation, over only the last few years a novel strategy of skin surface electrical spinal stimulation has also demonstrated exciting potential for improving walking function. Using a high-frequency stimulation pulse, current can pass through the skin without discomfort and activate the spinal cord; this results in patterned stepping movements for people without SCI and improved lower extremity function following SCI. This study will directly compare skin-surface transcutaneous stimulation with implanted epidural stimulation for improving lower extremity function.
Spinal Cord Injuries, Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases, Trauma, Nervous System, Wounds and Injuries
This is a single blind, sham controlled crossover trial that will evaluate the effectiveness of acute intermittent hypoxia therapy (AIH) combined with transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals after spinal cord injury.
Spinal Cord Injuries, Spinal Cord Diseases
A non-randomized study evaluating the efficacy of intravesical gentamicin on the occurrence rate of urinary tract infections and bladder complications in patients after spinal cord injury (SCI), and to assess its effectiveness in promoting overall quality of life (QOL), community living, and participation.
Urinary Tract Infections, Spinal Cord Injuries, Spinal Cord Diseases, Neurogenic Bladder
The SciExVR study will evaluate the potential benefit of autologous bone marrow derived stem cells (BMSC) in the treatment of spinal cord injury with evidence of impaired motor or sensory function. The treatment consists of bilateral paraspinal injections of the BMSC at the level of the injury as well as superior and inferior to that spinal segment followed by an intravenous injection and intranasal placement. Patients undergoing BMSC treatment may also be assigned to use of exoskeletal movement (or equivalent) or virtual reality visualization (or equivalent) to augment upper motor neuron firing and/or receptivity of the sensory neurons. http://mdstemcells.com/sciexvr/
Spinal Cord Injuries, Spinal Cord Compression, Spinal Cord Ischemia, Spinal Cord Diseases, Spinal Paralysis, Paraplegia, Paraplegia, Spinal, Paraplegia/Paraparesis, Paraplegia; Traumatic, SCI - Spinal Cord Injury
Spinal cord injury (SCI) is debilitating to an individual's health, functional capacity and quality of life. This contributes to a sedentary lifestyle and an elevated risk for cardiometabolic and hypokinetic diseases. While physical activity is promoted in persons with SCI to reduce incidence of secondary disabling conditions, a majority of individuals are inactive and have low levels of fitness. High intensity interval training (HIIT) is a form of exercise characterized by brief, intermittent bouts of intense exercise, separated by periods of lower intensity exercise for recovery. The level of improvements in aerobic exercise capacity following HIIT are similar to moderate-intensity continuous training, but only require a fraction of the total energy and time commitment. Little research has been done on HIIT in persons with SCI, who are unable to carry out conventional lower limb HIIT exercises. An upper extremity form of HIIT that is effective, safe, and quick could be an attractive option for these individuals. The study will look at feasibility and acceptability of a 6-week HIIT program for persons with a spinal cord injury who are untrained. Investigators will test 10 untrained individuals with SCI/D who use a manual wheelchair full time. Prior to any testing, participants will be screened and will need to obtain a signed medical release from their physician. The screening involves asking the participant the inclusion/exclusion criteria and administering two short questionnaires related to physical activity. After obtaining the release form, participants will be scheduled for their first visit. During Visit 1, baseline testing and questionnaires will be completed. The study questionnaires will address sociodemographics, pain and health measures, general health, and physical activity. Exercise testing includes an aerobic exercise stress test (conducted following American College of Sports Medicine guidelines using an electronic ergometer) and an anaerobic (maximum power output) test. After Visit 1, participants will exercise three times per week for six weeks, following a standard HIIT protocol. Two of those sessions will be supervised by a trainer, and one session will be completed on their own. After six weeks, participants will be scheduled for Visit 2 and will complete the same evaluations as Visit 1. Additionally, participants will complete evaluations on their level of satisfaction of the training program and their likelihood to continue.
Spinal Cord Injuries, Spinal Cord Diseases
The CENTAUR trial was a 2:1 (active:placebo) randomized, double-blind, placebo-controlled Phase II trial to evaluate the safety and efficacy of AMX0035 for the treatment of ALS.
Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Neuromuscular Diseases, Neurodegenerative Diseases, Spinal Cord Diseases, TDP-43 Proteinopathies, Nervous System Diseases, Central Nervous System Diseases
This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries.
Quadriplegia, Spinal Cord Diseases, Spinal Cord Injuries
Sleep-disordered breathing (SDB) remains under-treated in individuals living with spinal cord injuries and disorders (SCI/D). The investigators' aim is to test a program that addresses challenges and barriers to positive airway pressure (PAP) treatment of SDB among patients with SCI/D. The investigators anticipate that patients who receive this program will have higher rates of PAP use and will demonstrate improvements in sleep quality, general functioning, respiratory functioning and quality of life from baseline to 6 months follow up compared to individuals who receive a control program. This work addresses critical healthcare needs for patients with SCI/D and may lead to improved health and quality of life for these patients.
Spinal Cord Injury, Sleep-disordered Breathing, Spinal Cord Disease, Multiple Sclerosis
This study will evaluate the efficacy of a newly developed serious game, SCI HARD, to enhance self-management skills, self-reported health behaviors, and quality of life among adolescents and young adults with spinal cord injury and disease (SCI/D). SCI HARD was designed by the project PI, Dr. Meade, in collaboration with the UM3D (University of Michigan three dimensional) Lab between 2010 and 2013 with funding from a NIDRR (National Institute on Disability and Rehabilitation Research) Field Initiated Development Grant to assist persons with SCI develop and apply the necessary skills to keep their bodies healthy while managing the many aspects of SCI care. The study makes a unique contribution to rehabilitation by emphasizing the concepts of personal responsibility and control over one's health and life as a whole. By selecting an innovative approach for program implementation, we also attempt to address the high cost of care delivery and lack of health care access to underserved populations with SCI/D living across the United States (US). H1: SCI Hard participants will show greater improvements in problem solving skills, healthy attitudes about disability, and SCI Self-efficacy than will control group members; these improvements will be sustained over time within and between groups. H2: SCI Hard participants will endorse more positive health behaviors than control group members; these improvements will be sustained over time within and between groups. H3: SCI Hard participants will have higher levels of QOL than control group members; these differences will be sustained over time within and between groups. H4: Among SCI Hard participants, dosage of game play will be related to degree of change in self-management skills, health behaviors and QOL.
Spinal Cord Injury, Spinal Cord Involvement, Spina Bifida, Transverse Myelitis, Polio and Post-polio Syndrome, Syringomyelia, Spinal Stenosis, Spinal Neoplasms, Spinal Cord Diseases
The purpose of this study is to determine whether testosterone plus finasteride treatment will improve musculoskeletal health, neuromuscular function, body composition, and metabolic health in hypogonadal men who have experienced ambulatory dysfunction subsequent to incomplete spinal cord injury. The investigators hypothesize that this treatment will improve bone mineral density, enhance muscle size and muscle function, and improve body composition, without causing prostate enlargement.
Spinal Cord Injury, Spinal Cord Injuries, Trauma, Nervous System, Wounds and Injuries, Central Nervous System Diseases, Nervous System Diseases, Spinal Cord Diseases, Gonadal Disorders, Endocrine System Diseases, Hypogonadism, Genital Diseases, Male
The goal of the investigators work is to establish how nerve transfers can be best used to improve upper extremity function in patients with cervical level spinal cord injury (SCI). The investigators' hypothesis is that nerve transfers are safe and effective and will improve function and quality of life in patients with loss of upper function due to spinal cord injury. The investigators plan on looking at upper limb function, and health-related quality of life in patients before and after surgery to better understand how patients benefit from these treatments. A nerve transfer procedure can be used to rewire the system to make some muscles work again following SCI. The nerve transfer procedure (which is done in the arm and not at the level of the spinal cord) can be used to bypass the damaged area and to deliver a signal from the brain to a muscle that became disconnected following that injury. A donor nerve is taken from another muscle whose use is not essential and then transferred to help in providing more a more critical function. For example, one type of nerve transfer is done to restore the lost ability to pinch or grasp small objects between the fingers that occurs in many patients with cervical SCI. In this surgery, a donor nerve that normally helps flex the elbow. This nerve can be used because the biceps muscle is also working to flex the elbow. This donor nerve is cut and re-attached to the nerve going to muscles in the forearm that provide pinch by bending the tips of the thumb and index finger. Because the nerve transfer procedure involves cutting and reattaching nerve and muscle tissues, time is required to regenerate working connections between the nerves and muscle as well as to allow the brain to relearn how to use and strengthen that muscle.
Quadriplegia, Spinal Cord Diseases, Spinal Cord Injuries
The purpose of this trial is to determine the efficacy of spinal cord stimulation, using wire leads, to produce an effective cough in patients with spinal cord injuries.
Spinal Cord Injuries, Spinal Cord Diseases, Paralysis, Central Nervous System Diseases, Cough, Trauma, Nervous System, Wounds and Injuries
This study will demonstrate that vaporized marijuana results in antinociception when compared to placebo in subjects with spinal cord injury. To further evaluate potential benefits and side effects, the effect of different strengths of cannabis on mood, cognition, and psychomotor performance will also be measured.
Spinal Cord Injuries, Spinal Cord Diseases
The purpose of this study is to collect biofluid samples for the banking and usage in ALS research. Through comparison of these samples, the researchers hope to learn more about the underlying cause of ALS, as well as find unique biological markers, which could be used to develop new therapies.
Amyotrophic Lateral Sclerosis, Nervous System Diseases, Sclerosis, Motor Neuron Disease, Spinal Cord Diseases, Central Nervous System Diseases, Neurodegenerative Diseases, Neuromuscular Diseases, ALS