View clinical trials related to Sclerosis.
Filter by:The primary objective of the study was to evaluate the immunogenicity of Avonex® (interferon beta-1a) 30 mcg when administered subcutaneously (SC) to interferon-naïve participants with relapsing multiple sclerosis. The secondary objective of this study was to evaluate the safety and tolerability of Avonex® 30 mcg when administered SC to interferon-naïve subjects with relapsing MS.
Multiple sclerosis is a degenerative disease that affects more than 400,000 people in the US alone. MS is in fact the most common disabling neurological disorder in young adults. Symptoms of the disease can include problems with balance, walking, fatigue, weakness and vision. Over 85% of people with Multiple Sclerosis have problems walking. This can cause them to fall or have a constant fear of falling. To prevent falling, MS patients rely on equipment, such as walkers and canes. These costs can cause financial difficulties for MS patients and families. A significant problem that is only recently being studied is the relationship between falling and MS. Recent studies have shown that MS patients fall more often than those without MS, and also fall more than the elderly population. The consequent fear of falling is also an important problem, as those worried about falling will probably change their daily habits to lower their risk. This can mean keeping from certain physical and social activities or even staying indoors. Thus, falls and fear of falling can have negative medical, physical, psychological, and social consequences for the patient. Improving patients' walking may help reduce falls and the fear of falling. Treadmill training has been shown to improve walking in patients with MS and to lower their risk of falling. One way to train patients on a treadmill is with the use of robots that can help move their limbs in a more normal way. This kind of robot-assisted treadmill training may provide even greater benefits than treadmill training alone. The study is expected to last 6-7.5 months. One group of participants will receive weekly telephone calls and will be asked questions on other physical activities, falls, and activity limitations the patient had during the week. Participants assigned to robot-assisted treadmill training will receive twice weekly training session for 8 weeks, for a total of 16 sessions. Each session will last about 65 to 90 minutes. The goal of this study is to see if robot-assisted treadmill training will reduce falls and fear of falling in patients with MS. Robot-assisted treadmill training has been shown to be effective in reducing falls and fear of falling in Parkinson's disease patients. This type of training has not been tested in patients with Multiple Sclerosis. The proposed study will help to address this gap and also provide additional data on other possible improvements due to robot-assisted treadmill training including ambulation, social participation, fatigue, and balance.
The presence of foot drop limits normal gait. Our prior data has suggested that approximately 30% of MS patients have foot drop. Although we have observed that "task-specific" rehabilitation using the Lokomat can improve ambulation in chronic MS patients, subjects with "foot drop" have difficulty translating task-specific training to normative gait patterns over ground, despite improving speed and endurance. One of the key limitations of the Lokomat is a lack of robot-assisted training for the ankle joint. The Anklebot, an MIT-developed rehabilitation robot for the ankle, has the potential to address this. The device can move throughout three planes and train ankle flexion, extension, inversion and eversion; however, therapy with the Anklebot alone does not train the knee or hip. We plan to test whether subject foot drop and overall gait benefit more from Anklebot therapy alone or a combination of Anklebot and Lokomat.
The Immunological system is showing a diurnal rhythmicity. The Mediators that enhances inflammation are at highest level during the night. At the same time the endogenous production of cortisol is at its lowest. We want to study if there is a better effect of treatment with Methylprednisolone for acute MS-attacks if given at nighttime. The effect will be measured in relation to neurological deficits and function with Kurtzkes Expanded Disability Status Score (EDSS) and Multiple Sclerosis Functional Composite (MSFC). We want to see if the mean improvement in EDSS is greater in the group receiving treatment at night opposed to the group that get treatment during the daytime.
This is a multinational, multicenter, randomized, double-blind, parallel-group active extension of LAQ/5062 study (NCT00349193), assessing the tolerability, safety and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in participants with relapsing remitting multiple sclerosis (RRMS), followed by an open-label phase of laquinimod 0.6 mg daily. This study is LAQ/5063 (i.e., double-blind extension) and LAQ/5063 OL (i.e., subsequent open-label extension). - The first period of the extension study is an active, double-blind period. Participants from the active treatment arms in LAQ/5062 continue their assigned treatment in blinded fashion. Participants who were assigned to placebo treatment in LAQ/5062 are equally randomized in blinded-fashion to laquinimod 0.6 mg or laquinimod 0.3 mg. - Once termination visit of LAQ/5063 active double-blind phase (completion of the full 36 weeks or as requested by the Sponsor) is performed, all participants continue on laquinimod 0.6 mg daily as an open-label intervention. The open-label period continues as long as the Sponsor continues the development of laquinimod 0.6 mg for RRMS or early discontinuation.
The purpose of this study is : 1. To assess the ALS patient's satisfaction related to a hospital stay on the neurology floor of Hahnemann Hospital. 2. To compare the reported satisfaction of those individuals who stayed in a standard hospital room with those who stayed in Room 1455. Room 1455 is a room specifically set up with assistive technology related to environmental controls for individuals with disabilities. 3. To look at frequency of use of the various pieces of adaptive equipment.
The goal of this project is to determine whether this device is a practical and realistic means for ALS patients to operate their computers with only the use of facial, brainwave, and eye movements. This study is intended to evaluate both the complexity of the system and the degree to which complications of ALS (such as severity of involuntary movements) may interfere with the use of cyberlink.
The literature to date indicates that noninvasive positive pressure ventilation (NIPPV) provides effective noninvasive ventilator support, prolongs survival, and improves quality of life (QOL) in Amyotrophic Lateral Sclerosis (ALS) patients. It is generally recommended to patients when their pulmonary function testing demonstrates a drop to 50% forced vital capacity (FVC). One result of using NIPPV may be a reduction in the work of the breathing which would lead to decreased caloric needs. However, the work of breathing and the effects of noninvasive ventilation on caloric use have not been studied in patients with ALS. This is extremely important since there may be a reduction in the caloric needs when ALS patients are placed on NIPPV and if the caloric intake is not adjusted, overfeeding can occur. Overfeeding with too many calories can lead to an increase in carbon dioxide which would actually worsen the respiratory failure. The overall aim of this project is to evaluate how many calories are used by ALS patients while at rest, when placed on NIPPV, and when breathing against a resistance. This will be accomplished using a metabolic cart during these activities. At present, the metabolic cart is routinely used in ALS patients at the time of feeding tube placement to calculate caloric needs. Using the cart to calculate the caloric expenditure on and off the ventilator will aid in calculating the work of breathing and the effects of NIPPV on work of breathing.
The work of Nau et. al (Nau KL, Bromberg MB, Forshew DA, Katcha Vl. Individuals with amyotrophic lateral sclerosis are in caloric balance despite losses in mass. J Neurol Sci 1995;129 :47-49) showed that patients in the early stages of ALS initially increase their body fat. Another study showed that advanced ALS patients on mechanical ventilation were actually hypometabolic, supporting a hypothesis that ALS patients' daily oral intakes of calories fail to match their energy requirements, thus exacerbating their condition. This current study investigates and compares substrate utilization using a metabolic cart in controls and in ALS patients who are on and off ventilatory support to examine differences in substrate utilization between the two groups of ALS patients and the controls. (Substrate utilization is essentially the percentage of fats, carbohydrates, and protein utilized by the body.) The study will increase our understanding of the nutritional needs of ALS patients and improve our ability to provide the best possible nutrition in progressive illness.
A two-stage prospective observational cohort study in scleroderma patients to evaluate screening tests and the incidence of pulmonary arterial hypertension and pulmonary hypertension