Implementation Intention for Physical Activity in Multiple Sclerosis
MotivationMindfulnessThe purpose of this study is to evaluate the effectiveness of an 8-week intervention based on implementation intention (motivation) in patients with multiple sclerosis on objectively measured physical activity.
Effect of Ocrelizumab on Neuroinflammation in Multiple Sclerosis as Measured by 11C-PBR28 MR-PET...
Multiple SclerosisUsing magnetic resonance-PET (MR-PET) imaging with [11C]PBR28, a second-generation 18kDa translocator protein (TSPO) radiotracer, we have previously demonstrated abnormally high TSPO expression, indicative of microglia activation, across different brain tissue compartments of multiple sclerosis (MS) patients1. In this study, we propose to study the efficacy of ocrelizumab, a humanized monoclonal antibody that has been shown to decrease neuroinflammation in relapsing-remitting multiple sclerosis (RRMS) and progressive multiple sclerosis (MS) patients. We will test these effects by studying a cohort of 24 MS patients (12 RRMS, 12 progressive MS). Participants will be studied before (within 3 months prior to initiating treatment) and after treatment with ocrelizumab (~12 month follow up), a therapeutic drug that will be part of their standard medical care. We will use [11C]PBR28 to help determine changes in neuroinflammation. The purpose of this study is to determine the effects of ocrelizumab treatment on neuroinflammation by analyzing the uptake and distribution of [11C]PBR28 in individuals with multiple sclerosis. The specific aims of the current study are: To assess whether treatment with ocrelizumab in subjects with either relapsing-remitting MS or progressive MS is associated with decreased [11C]PBR28 binding in the cortex and white matter (lesions and normal appearing white matter), suggesting reduced neuroinflammation. To assess whether changes in neuroinflammation under ocrelizumab treatment, as measured by [11C]PBR28 uptake at 12-month follow up relative to baseline, are associated with changes in structural MR metrics of brain tissue damage including white matter lesion load, cortical atrophy, and demyelination in the cortex and in the normal-appearing white matter as measured by magnetization transfer ratio (MTR). To explore whether changes in functional and structural imaging metrics under ocrelizumab are associated with changes in clinical outcome measures.
Effectiveness of a Schema Therapy on Anxiety in Patients With Multiple Sclerosis
AnxietyIt is a multicentric randomized and controlled study comparing a Scheme therapy program versus local practice in RRMS patients with anxiety. Patients will assist to twenty once-weekly group sessions with a 6-month follow up after the end of the programme. The main criteria is the impact of schema therapy on anxiety evaluated by the questionnaires at the end of the program and at the end of the 6-month follow-up.
Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis
Multiple SclerosisThe effects of multiple sclerosis (MS) on cognition, thought to occur in 50-75% of persons with MS, have gained increasing recognition as one of the major disabling symptoms of the disease. While numerous studies have addressed the emotional and physical impact of MS, little attention has been given to strategies that might help manage the cognitive changes commonly experienced by persons with MS. The proposed study will test a novel computer-assisted cognitive rehabilitation intervention, MAPSS-MS (Memory, Attention, & Problem Solving Skills for Persons with MS). The MAPSS-MS integrates the powerful effects of group interventions to build self-efficacy for new cognitive compensatory strategies/behaviors with individual home-based computer-assisted training. The computer training will assist individuals to develop cognitive skills that they can apply to everyday life using the compensatory strategies learned in the class sessions. In the recently completed exploratory study with 61 persons with MS (R21NR011076), the eight-week MAPSS-MS intervention was acceptable and feasible and had medium to large effects on the use of compensatory strategies and performance on neuropsychological tests of verbal memory. The proposed study will test the refined MAPSS-MS intervention with a larger more diverse sample (N=180) across multiple sites, extend the period of post-intervention follow-up to 6 months and establish whether performance improvements on neuropsychological tests make the important transfer to improved neuro-cognitive functioning in everyday life. The specific aims of this study are to: (1) Evaluate the efficacy of the novel MAPSS-MS cognitive rehabilitation intervention to improve overall neuro-cognitive competence in activities of daily living including verbal memory performance, use of compensatory cognitive strategies and performance on cognitive-related instrumental activities of daily living (IADL) among persons with MS; (2) Evaluate the efficacy of the MAPSS-MS intervention to improve self-efficacy and related aspects of cognitive performance (non-verbal learning/memory, information processing speed and attention, verbal fluency and complex scanning and tracking) among persons with MS; and (3) Determine the number of intervention participants who achieve and maintain their self-identified cognitive goals three and six months following the intervention. The effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with a comparison group receiving usual care computer games. Measurements of study variables will occur at baseline, immediately after the MAPSS-MS intervention, and three months and six months after the intervention is complete. Statistical analysis will include descriptive statistics and HLM analysis to account for the nested design. The intent-to-treat approach will be used. Public Health Statement: This research will provide new knowledge about an innovative intervention to improve memory, use of compensatory strategies, and performance of cognitive activities and instrumental activities of daily living for persons with MS. If effective, the intervention would provide a new and feasible approach to target a serious, debilitating problem commonly experienced by persons with MS.
Self-administered Hyperinsufflation Chest on the Risk of Low Respiratory Infection in Patients With...
Multiple SclerosisIn patients with neuromuscular disease, chest mobilization by hyperinsufflation slows respiratory decline by almost 80% compared to controls, and prevents complications like pneumonia, atelectasis and respiratory distress. This insufflation technique improves the airway clearance and reduces the need for invasive ventilation. It also improves CV and DEPtoux in patients with neuromuscular pathology
Fall Risk Reduction in Multiple Sclerosis (FIRMS)
Multiple SclerosisThis study looks to see the effects of a home based exercise program on falls in people with MS.
Use of an Electronic Diary by People With Multiple Sclerosis
Multiple SclerosisMultiple Sclerosis (MS) is the most common chronic neurological disease affecting young adults, with onset usually at the age 20-40. Disease modifying therapies are available to MS, as well as drugs to improve patients' symptoms. Choosing the optimized treatment for each patient is a challenge to neurologists since predictive biomarkers for therapy are yet to be validated and approved. Current therapy decisions are based predominantly on clinical evaluation of disability and disease relapses. Adherence to treatment in MS is sub-optimal. Over the past few years a growing involvement of patients in their healthcare is noted, specially in chronic diseases, and Patient Reported Outcomes (PRO) are being incorporated as part of therapy evaluation. Several electronic patients diaries to track adherence to therapy, PRO and drugs side effects in diseases such as epilepsy are available. A mobile interactive patient diary (e-diary) tailored for persons with MS was developed. Users can enter data on drugs intake, drugs-side effects and disease symptoms and receive reminders regarding adherence to treatment. The aim of this study is to assess the benefits of the use of an e-diary for MS patients on healthcare. In order to achieve this goal, 80 MS patients will be randomized into two groups: a study group with access to the e-diary and a control group. After a period of one year, satisfaction with the e-diary will be assessed. The effect of the use of the e-diary on quality of life, on clinical outcomes and on adherence to therapy will be evaluated by comparing the two groups. This study will indicate the possible contribution of an e-diary for the evaluation of drugs safety and efficacy and of patient adherence to therapy, to be applied in clinical trials and towards improvement of MS patient' care.
MS and NMOSD in African-Americans
Multiple SclerosisNeuromyelitis OpticaThis is a prospective study that aims to collect and review neuromyelitis optica spectrum disorder (NMOSD) data from African American patients with a known diagnosis of multiple sclerosis (MS). It is an investigational study, prospective in nature. No randomization of patients will be done. Information collected includes: Age, gender, age at diagnosis, MRI data (access to images), clinical presentation, findings on clinical examination, lab (blood and evoked potentials) and LP test results, eye exam findings if any and treatment, if started. Additional details may include other NEUROLOGICAL diseases which are also diagnosed (if any).
Observational Study in Patients With Relapsing-Remitting Multiple Sclerosis Switched to Bafiertam®...
Relapsing Remitting Multiple SclerosisThis is an open-label, multicenter, observational study evaluating GI symptoms in relapsing-remitting multiple sclerosis (RRMS) patients who switch from dimethyl fumarate (DMF) to Bafiertam®.
QOLBET Quality Of Life in Patients With Early Relapsing-remitting Multiple Sclerosis Treated With...
Multiple SclerosisRelapsing-RemittingThis study is to describe the quality of life of Korean patients with early relapsing-remitting multiple sclerosis during the initial 1 year of treatment with Betaferon with several validated questionnaires.