
Effects of Training on Central Auditory Function in Multiple Sclerosis
Multiple SclerosisThe purpose of this study is to characterize the central auditory processing (CAP) deficits that result from multiple sclerosis (MS).

Physical Disability in Patients Treated With Betaferon
Multiple SclerosisTo gather Observation data about physical disability progression, safety and adherence during the use of Betaferon in daily practice. Patients with any type of Multiple Sclerosis (MS) (MRRS) (PSMS), under treatment with Betaferon.Open Multicentric Observational study.24 months.Evaluation of physical disability in patients treated with Betaferon, using Kurtzke's expanded disability scale (EDSS) in biannual periods

Effect of Fasting on the Size of Abdominal Lymphatic Tumors in Women
LymphangioleiomyomasTuberous Sclerosis1 moreThis study will examine the effect of fasting on lymphangioleiomyomas abdominal tumors formed from enlarged lymph nodes containing lymphatic fluid. Previous studies have determined that these tumors increase in size in the evening, but this result could stem from the fact that previous study participants were tested after eating lunch. The purpose of the study is to help researchers understand the factors that produce changes in size of lymphangioleiomyomas, as well as to improve the ability of medical professionals to diagnose lymphangioleiomyomas and avoid confusing these tumors with other malignant tumors. Volunteers must be women who are at least 18 years of age and who have been diagnosed with lymphangioleiomyomas in the abdominal or pelvic areas. Candidates who have had lung or kidney transplants or who have type 1 diabetes will be excluded. Candidates will be screened with a physical examination and medical history. During the study, participants will be admitted to a National Institutes of Health clinical center for three days to undergo a number of tests. Tests will include routine blood and urine tests, and electrocardiogram, research blood testing, and abdominal and pelvic ultrasounds....

Validation of Biomarkers in Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral SclerosisLou Gehrig's Disease3 moreThe purpose of this study is to collect 650 blood and 300 cerebrospinal fluid (CSF) samples from people with amyotrophic lateral sclerosis (ALS), pure lower or upper motor neuron diseases, as well as other neurodegenerative diseases and from people with no neurological disorder. 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 diagnose ALS and monitor disease progression. Additionally, up to 600 blood samples will be collected for a sub-study for DNA analysis. Studying components of the blood, such as DNA, may help us understand what happens when genes function abnormally and how it might be related to disease.

Compassionate Use of Ceftriaxone in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral SclerosisCerebrospinal Fluid2 moreAmyotrophic lateral sclerosis is a uniformly progressive and fatal neurodegenerative disorder for which there is no known cure. In a novel attempt to widen the search for potential therapeutic agents, a NINDS- led cooperative group performed an in-vitro screening program of 1040 FDA approved drugs in over 28 assays relevant to various neurodegenerative disorders. Several cephalosporins showed hits in ALS relevant assays. Efficacy was noted in models suggesting increased expression of the astrocytic glutamate transporter, EAAT2, as well as models of superoxide dismutase mediated toxicity. Ceftriaxone is a third generation cephalosporin with good CNS penetration, a long half-life, and was effective in both types of ALS assays. Ceftriaxone has calcium binding activity, antioxidant properties, and rescues motor neurons in culture from chronic glutamate toxicity. Since completion of the original NINDS screen, Ceftriaxone has been shown to increase by three fold EAAT2 activity in rodent brains, due to ceftriaxone's ability to increase EAAT2 promotor activation This program is for the use of ceftriaxone in ALS for compassionate care. Currently ceftriaxone is approved by the U.S. Food and Drug Administration (FDA) for treating bacterial infections but not for treating ALS. However, there is an ongoing phase I study -by NEALS Consortium and the National Institute of Health- with three cohorts -a placebo group and two groups receiving either 2 or 4 grams of ceftriaxone daily-. Unfortunately there are only a limited number of patients being enrolled and the next phase of the project will not be undertaken until next year. At this point there are ALS patients unable to participate in this Phase I trial and unlikely to be alive when the next phase of study begins. Some of these patients want to receive the drug and are willing to pay for the drug and nursing care. We are therefore requesting a compassionate use protocol for these patients who request the medication and are willing to pay for the drug and nursing care to administer it. Dr. Terry Heiman-Patterson will supervise the administration and safety monitoring including labs for renal and hepatic function as well as IV site inspection.

Assessment of Patient Use of a New Device: RebiSmart
Multiple SclerosisMultiple sclerosis (MS) is a chronic disease which causes inflammation and destruction of the nerves in within the brain and the spinal cord. This disease is one of the most common causes of disability in young adults. A ''relapse'' is a phenomenon that occurs when there is an acute attack of disability as a result of an acute attack on the nervous system. There is usually some degree of recovery after a relapse. Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3 times a week by injections under the skin. The RebiSmart device is a new injection device which has been developed to help patients with injecting their Rebif treatment. Currently, all treatments for MS are injectable and require long term patient commitment. Patient compliance to treatment is important for the therapy to work effectively and decrease the risk of relapse episodes. Using a device that makes it easy for patients to inject may potentially improve compliance to treatment and therefore potentially have an impact on the number of relapses patients experience. The RebiSmart device has been developed for patients to inject conveniently and in comfort. The device allows the patient to control certain parameters such as needle depth, needle speed, injection time etc, and also has extra features designed to ease the injection process, such as a dose history calendar and an on-screen injection guide. The aim of this study is to determine what percentage of patients liked using the RebiSmart device and found it ''easy'' or ''very easy'' to use. The study will also determine which of the device features were most useful to the patients.

Depression and Fatigue in MS Patients Treated With Betaferon.
Multiple SclerosisThis study aims to evaluate the occurence and severity of fatigue and depression in multiple sclerosis patients and the impact of Betaferon treatment on symptoms alterations. The study is conducted in routine practice setting hence no interference with standard care takes place. Pharmacologic treatments of MS-fatigue and depression will also be recorded.

Betaseron Pregnancy Registry
Birth DefectsPregnancy Complications1 moreThis is a prospective, observational, registration and follow-up study of women exposed to Betaseron® at the time of conception (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The Betaseron® Pregnancy Registry is designed to determine whether there is an increased risk or a pattern of birth defects in the offspring of women exposed to Betaseron® at conception and during pregnancy compared to rates from women in the general US population. Secondarily, the Registry will examine rates of spontaneous abortions and other negative pregnancy outcomes in this population. This study will be conducted in the United States (US). The Betaseron® Pregnancy Registry is sponsored by Bayer HealthCare Pharmaceuticals and is managed by the Post Approval & Strategic Services group at INC Research, LLC. The scientific conduct and analysis of the Registry will be overseen by an Independent Data Safety Monitoring Board (IDSMB) consisting of external specialists in teratology, epidemiology, maternal and fetal medicine, and neurology (external member details available upon request).

Effects of Gastrostomy on Amyotrophic Lateral Sclerosis
Amyotrophic Lateral SclerosisResults about effects of symptomatic treatment on QoL appears conflicting in ALS patients. Moreover no clear effects of gastrotomy have be shown on survival. Prospective study on effect of tube feeding, QoL and survival is performed in 17 teaching hospitals in France (observational study)

Exposure to Neurotoxins as Risk Factors for Amyotrophic Lateral Sclerosis
Amyotrophic Lateral SclerosisALSThis study is a follow-up to an earlier study that examined the relationship of This study will examine whether exposure to neurotoxins, such as lead, mercury, solvents, and pesticides, can contribute to amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. The cause of this degenerative disease of the brain and spinal cord is not well understood. Some studies suggest that exposure to environmental neurotoxins may increase its risk. This follow-up study will examine the relationship of neurotoxin exposure to the interval between the diagnosis of ALS and death. It will also examine the possible roles of genetics, lifestyle and dietary factors in the disease. Information on ALS patients previously enrolled in the study will be used to examine this relationship. No new individuals will be enrolled in the study.