Active clinical trials for "Muscular Atrophy"

The primary objective of this study is to evaluate the long-term safety and tolerability of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA) who previously participated in study 232SM203 (NCT04089566). The secondary objective of this study is to evaluate the long-term efficacy of nusinersen administered intrathecally at higher doses to participants with SMA who previously participated in study 232SM203 (NCT04089566).

The goal of this randomized, double-blind, parallel group interventional study is to evaluate the effect of ketone bodies on healthy older adults (65-85 y) during 5 days of bed rest. The main questions it aims to answer are: Does supplementation of ketone bodies prevent the typical decline in muscle protein synthesis, muscle size, muscle function, insulin sensitivity, and muscle mitochondrial function that occurs in response to bed rest? Researchers will compare ketone supplements (KET) to an energy matched control beverage (carbohydrates and fats) to see if the ketones can rescue the decline in muscle protein synthesis rates, muscle loss, muscle function, insulin sensitivity, and mitochondrial function due to 5 days of bed rest. This may positively impact the heath of older adults subjected to bed rest.

Low mobility during an acute care hospitalization is very frequent, particularly among older patients, and associated with adverse outcomes, such as persistent functional decline, institutionalization and death. However, increasing hospital mobility remains challenging because of the multiple existing barriers. The goal of this clinical trial is to test the effect of a multilevel intervention to increase hospital mobility, which addresses modifiable barriers and facilitators and does not require unavailable additional resources. This study aims to answer whether this intervention can improve mobility and patient-relevant outcomes such as life-space mobility and functional status. The multilevel intervention will target: The patients, who will receive an information booklet, a customizable diary, an exercise booklet and an iPad with access to the videos of the exercise booklet. The healthcare professionals (nursing staff and physicians) who will complete an e-learning, receive an oral presentation on the intervention, and receive a "mobility checklist" that reminds them of what they should assess daily regarding mobility. The hospital environment, where posters will be hung in the wards, including walking itineraries, on topics of interest to older adults. In a first phase, the intervention will be pilot-tested in one ward of each hospital. The intervention will then be adapted based on patient and healthcare professional feedback. In a second phase, the intervention will be tested in a cluster randomized controlled trial, and compared to standard of care.

Intensive Care Unit Acquired Weakness (ICUAW) describes muscle weakness that occurs in around 40% of patients during an intensive care stay. The morbidity and mortality of these patients is significantly increased over a 5-year period. The aim of this study is to investigate the combined effect of early enteral high-protein nutrition and early muscle activation on muscle atrophy in critically ill patients. The study will include 40 patients (20 intervention, 20 observation) with requirement for enteral nutrition at time of inclusion. In the intervention group the maximum possible level of mobilization is carried out and muscles are activated twice a day using neuromuscular electrical stimulation (NMES). The nutrition plan of the intervention group is based on the applicable guidelines for intensive care medicine with exception of increased protein intake. The control group receives therapy without deviating from the standard according of the DGEM guideline. The study aims to show that the decrease in muscle mass is significantly less than in the control group (primary hypothesis) via ultrasound of the rectus femoris muscle and in case of given consent muscle biopsy. As secondary hypothesis it is examined whether the combination of early high protein intake and muscle activation improves muscle strength and endurance.

The major aim of this project is to assess comprehensively frequency and extent of dysphagia and bulbar dysfunction in SMA1, 2, and 3 patients by applying FEES and validated dysphagia scores. Further aims are to follow changes of dysphagia over time in newly diagnosed patients, and in subjects starting treatment with one of the new therapeutic SMA drugs. Special attention will be paid to subjects treated with Risdiplam. If applicable, the data will be compared between groups receiving different drugs.

Skeletal muscle accounts for approximately 45-55% of total body mass in healthy adults and plays a pivotal role in whole-body metabolic health, locomotion and physical independence. Undesirable loss of skeletal muscle mass (atrophy) is, however, a common feature of many communicable and non-communicable diseases including ageing, bed-rest/immobilisation, cancer and physical inactivity. As such, the design of optimal strategies (e.g., different types of exercise) to "offset" these detrimental losses of muscle is a focus for both researchers and clinicians. One situation where losses of muscle mass occur very quickly (i.e., within a few days) is after surgery. However, at this time, most people (especially if they have had major abdominal or lower-limb surgery) are not able to perform exercise and as such a different strategy to maintain muscle mass needs to be found. It has been shown that electrical stimulation of the leg muscles can maintain muscle mass and function in patients after surgery. It is not however yet known, what the optimal electrical stimulation regime is to preserve muscle mass during situations of disuse. This study aims to examine the impact of three different electrical stimulation protocols on muscle building processes in individuals age-matched to those most commonly presenting for major abdominal surgery. This information will then be used in a clinical trial of surgical patients to see if it can preserve their muscle mass and function in the post-operative period.

Spinal cord stimulation (SCS) has shown remarkable efficacy in restoring motor function in people with spinal cord injury by recruiting afferent input to enhance the responsiveness of spared neural circuits to residual cortical inputs. This pilot will test if SCS can show evidence to improve motor deficits in people with type 3 or 4 spinal muscular atrophy (SMA). The investigators will enroll up to six subjects with Type 3 or 4 SMA aged 16 or older that show quantifiable motor deficits of the legs but are able to stand independently. The investigators will then implant the subjects with percutaneous, bilateral, linear spinal leads near the lumbar spinal cord for a period of up to 29 days. Although these leads are not optimized for motor function but rather for their clinically approved indication of treating pain, the investigators believe they provide a safe technology enabling our team to perform scientific measurement necessary to evaluate potential for effects of SCS in motor paralysis with SMA. After the end of the study, the leads will be explanted.

Canada's Food Guide places an increased emphasis on plant-based proteins; however, Canadians who consume a plant-based diet may be compromised because of intake of lower-quality protein. Consumption of high-quality protein is important during growth and development, especially in highly active individuals. The study will compare milk (i.e. high quality protein) to a pea-based beverage (i.e. lower quality plant-based protein) in adolescent boys and girls who are engaged in resistance-training programs as part of their athletic training. One-hundred and fourteen adolescent boys and girls (12-17y of age) will be divided into groups that consume milk, a pea-beverage, or a carbohydrate (sugar) beverage after resistance training sessions performed three times per week for six months. It is predicted that the group consuming milk will have greater increases in muscle mass, strength, and bone density, and greater reductions in fat mass compared to the groups consuming a pea-based or carbohydrate beverages.

The randomized controlled trial is aimed to discover the physiotherapy and hippotherapy effect and efficacy on children with SMA. The concept is to utilized two types of physiotherapy - the first concept is classic physiotherapy and the second one is hippotherapy. The hippotherapy concept will be in intervals of 15 minutes twice a day, the physiotherapy will be in intervals of 30 minutes once a day. In-patient therapy will be for 6 days. The efficacy will be assessed by biomedical measures - Qualisys Motion Capture Systems 2020.3., by molecular biological markers (lncRNA) in blood and by surface electromyography (EMG). The primary goal of this study is to compare two physiotherapeutic approaches - the recommended form of classical physiotherapy and the method on a neurophysiological basis - hippotherapy. The secondary intention of the research will be the appropriate intensity of therapy so that unwanted muscle fatigue does not occur.

The Synchron motor neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility. The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.