Carolinas HealthCare System

Research and Clinical Trials

ALS - Amyotrophic Lateral Sclerosis 

Brief Description PrincipalĀ Investigator
The primary objective is to identify factors that contribute to the pathogenesis of amyotrophic lateral sclerosis (ALS). Development of disease biomarkers and diagnostic laboratory tests would facilitate earlier treatment intervention, help monitor treatment efficacy; and, ultimately, lead to the identification of targets that could be used in therapy development. Specific aim 2 is to assess how biomarkers discovered in aim 1 change with disease course. Blood samples will be collected longit Brooks, Benjamin 
The purpose is to determine if the NeuRx(R) Diaphragm Pacing SystemTM (DPS) for people with ALS and hypoventilation is associated with improved survival or diaphragm function. Subjects will be randomly assigned in a 2:1 ratio to DPSX or standard of care (control) treatment. The DPS group will have the DPS device surgically implanted. Subjects will remain on DPS or standard of care treatment for the duration of the study (12-36 months). Brooks, Benjamin 
To see if ibudilast is safe to take and doesn't have too many side effects, and can help people with ALS in slowing down the progression of the disease. Subjects will be randomly assigned in a 2:1 ratio to ibudilast or placebo. Ibudilast and placebo are in pill form and are taken daily by mouth. For Part 1 of study, subjects will remain on ibudilast or placebo for six months. For Part 2, people who were assigned to take placebo during Part 1 will take ibudilast for 6 months; Brooks, Benjamin 
The purpose of this study is to find out whether a high fat or high calorie diet is safe and can be tolerated by people with amyotrophic lateral sclerosis (ALS). ALS is a progressive neurodegenerative disorder that usually leads to death in 2 to 5 years. Rapid weight loss is a hallmark of the disease, due to inadequate caloric intake and, in 80% of patients, a hypermetabolic state. Approximately 60 ALS subjects, at different treatment centers, already receiving nutrition from a tube in their st Brooks, Benjamin 
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