Assessment of a Clinical Decision Support System (CADIMS) for Improving Multiple Sclerosis Diagnostic Accuracy
1. Background The results obtained in clinical research led to a new paradigm for the treatment of patients affected with multiple sclerosis (MS): "no evidence of disease activity". This means having each patient monitored with high quality imaging. To this purpose, researchers have developed segmentation algorithms for automated reading of MRIs, facilitating longitudinal comparisons, and allowing an accurate assessment of the number and the volume of focal lesions. We have thus a powerful strategic biomarker for the treatment of MS. Due to the relevance of comparing over time the evolution of lesions (lesion load) and brain atrophy, the French Society of Neuroradiology edited standardized national recommendations. The MS French Observatory (OFSEP) has adopted these recommendations, in order to harmonize exams for all patients all over the country. At an international level as well, MRI have been put at the heart of the therapeutic strategy. Therefore, we need now to create the conditions able to implement, collect and analyze imaging data according to these recommendations. This is the meaning of the MUSIC project, which aims to develop and assess a standardized monitoring MRI control tool for therapeutic decision. CADIMS is this tool. It is based on an integration of several segmentation algorithms developed by INRIA and an image viewer developed by b<>com and included in a regional images-sharing server ETIAM Nexus. This tool is a help showing segmented brain T2 lesions, gadolinium-enhanced T1 lesions and news T2 lesions appeared from the previous MRI exam, in a multicenter clinical context. 2. Objective To evaluate the accuracy of MS lesions detection on cerebral MRI by comparing the CADIMS tool to the expert consensus.
NCT03205280 — Multiple Sclerosis, Relapsing-Remitting
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis-relapsing-remitting/NCT03205280/
Effect of Need to Void on Gait Speed in Multiple Sclerosis
Multiple sclerosis causes demyelinating lesions, which can induce multiple symptoms. If motor disorders are the most visible disability, urinary disorders are frequent, with prevalence from 32 to 86%. The first ones are due to pyramidal, cerebellar or proprioceptive lesions. The seconds are due to specific lesion in inhibitor/activator encephalic centers, or interruption on medullary conduction. It seems to be evident that walk and urinary disorders are link, because of similar anatomic ways and control process. Effect of bladder filling is well known on motoneuronal excitability. The effect of bladder filling on walk stay unknown, while medullary integration of these two functions is very close, in medullary cone. Primary aim is to assess the effect of need to void on walk speed in multiple sclerosis with lower urinary tract symptoms. Secondary aim is to identify clinical or urodynamic factor link with major walk impairment when patients need to void. Patient with multiple sclerosis over 18 years old, consulting for lower urinary tract symptoms in a tertiary center are included. History and treatment, high, weigh, symptoms severity by USP score, cognitive impairment by MMSE score and last urodynamic data are recorded. Patient are asked to drink water until they feel a strong need to void, for which they would go to urinate at home. Walk tests are realized in a specific place, with calm and no passage. A chair is placed at each end of the path. Toilets are just next to the hall where they realize the tests. A 10 Meters Walk Test is done during this condition, 3 times (only the intermediate 6 meters are recorded). They can take 30 seconds of rest between each try if necessary. One Timed up and go is done. Patient can use their habitual walking device. Speed walk asking is comfortable for the two test. Next, patient can urinate. 3 post void residual volume with portable echography are done, and the higher is recorded. Patient achieve the same walk tests after urinate, in the same order. They must use the same walking device. Primary outcome is mean gait recorded for 10 meters walk test. Secondary outcome is time for timed up and go test. Individual variability between the 3 10MWT in the two conditions will be study. Influence of age, EDSS, severity of symptoms, MMSE, detrusor overactivity on speed impairment will be study in secondary analysis.
NCT03204747 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT03204747/
Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis
The 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.
NCT03200899 — Multiple Sclerosis
Status: Active, not recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT03200899/
Effects of Yoga Practice in Multiple Sclerosis Patients: a Multidimensional Approach
In this study the investigators will evaluate the effects of yoga practice on multiple sclerosis patients and healthy controls for fatigue, quality of life, movement, cognition, brain activity, self-efficacy, stress, anxiety, depression, affective states and immunological response. To investigate the effects of yoga training delivered by a yoga instructor or through a smartphone application, the investigators will use a multidimensional approach that comprises of: evaluation of neuropsychological, quality of life and affective aspects, structural and functional magnetic resonance imaging, functional near infrared spectroscopy (fNIRS) combined with movement analysis (gait, strength, balance etc.) and analysis of the immune response.
NCT03198598 — Multiple Sclerosis
Status: Active, not recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT03198598/
COMparison Between All immunoTherapies for Multiple Sclerosis. An Observational Long-term Prospective Cohort Study of Safety, Efficacy and Patient's Satisfaction of MS Disease Modulatory Treatments in Relapsing-remitting Multiple Sclerosis
The overarching goal of this study is to determine whether rituximab (RTX) offers effectiveness and safety advantages over other commonly used approved Disease-Modifying Drugs (DMT) in the largest real-world population-based structured prospective follow-up cohort of Relapsing-Remitting Multiple Sclerosis (RRMS) patients. The study will include both treatment naïve patients starting their first DMT and patients switching from a previous first line DMT (escalation/second-line).
NCT03193866 — Relapsing-remitting Multiple Sclerosis
Status: Active, not recruiting
http://inclinicaltrials.com/relapsing-remitting-multiple-sclerosis/NCT03193866/
Vaccine Exposure in Patients With Multiple Sclerosis in the Auvergne-Rhone-Alpes Region
Vaccines in MS patients have been controversial, in particular hepatitis B vaccine in the 90s and more recently human papillomavirus vaccine. There was an important flu incidence during the winter 2016-2017 that has revealed a low exposure to the flu vaccine in health professionals in France. Vaccine exposure of Multiple sclerosis (MS) patients has not been evaluated yet. Objectives The primary objective is to evaluate exposure to the flu vaccine in patients with MS during the 2016-17 campaign. Secondary objectives are to evaluate exposure to mandatory vaccines, non mandatory vaccines, in the context of immunoactive treatments; to identify potential limitations to vaccines in general in patients with MS. Methods Cross-sectional observational multicentric study, performed in Auvergne-Rhône-Alpes (France). Data will be collected through an auto-questionnaire administered during an out-patient visit or hospitalization, during a two-week period. Statistical analysis Description of the percentage of patients exposed to the flu vaccine, and to other vaccines. Stratification according to demographics (age, sex) and MS related criteria (disability level, relapse in the year before, disease-modifiying drug) Expected results Vaccine exposure of patients with MS will be put in perspective with the general population exposure. The study can provide information regarding potential reluctance of patients with MS towards vaccines. This could lead to develop specific communication tools for patients with MS and/or health professionals.
NCT03191669 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT03191669/
Cognitive Impairment in Pediatric Onset Multiple Sclerosis: Research of Biomarkers Predictive of Cognitive Impairment Progression
Computer-assisted rehabilitation of attention deficits in pediatric Multiple Sclerosis and ADHD patients recruited during the study "Cognitive impairment in Pediatric Onset Multiple Sclerosis: research of biomarkers predictive of cognitive impairment progression".
NCT03190902 — ADHD Predominantly Inattentive Type
Status: Completed
http://inclinicaltrials.com/adhd-predominantly-inattentive-type/NCT03190902/
Changes in Perceived Fatigue and Step Counts Before and After Rehabilitation. A Prospective, Single-center, Longitudinal Observational Study.
The primary objective is to evaluate changes in fatigue and physical activity (step counts) before and after rehabilitation in patients with MS (EDSS 3-6.5). The association of changes in fatigue and physical activity will also be analyzed for disease severity (EDSS), age, emotional status (depression) of the participants.
NCT03187847 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT03187847/
Effects of a Game-based Virtual Reality Video Capture Training Program Plus Occupational Therapy on Manual Dexterity in Patients With Multiple Sclerosis: a Randomizaed Controlled Trial
Introduction. Multiple sclerosis (MS) is the most common neurological disease causing disability in young adults. Neurorehabilitation is a fundamental aspect in the treatment approach for MS, in which new technologies have gained popularity, especially the use of virtual reality (VR), thanks to the therapeutic possibilities offered for patients with MS presenting cognitive, sensitive and motor dysfunctions. Aim. To analyze and compare an occupational therapy intervention (OT) compared with OT + VR (OT+VR) on the manual dexterity of patients with MS. Material and methods. 26 patients will be recruited. The control group (n=8) will recieve 20 conventional OT sessions distributed in two sessions per week. The experimental group OT+VR (n=8) will recieve 20 sessions of VR interventions, twice weekly and lasting 30 minutes, consisting of VR games accessed via the online webpage motiongamingconsole.com, including Flip Out, Air Hockey, Partículas, Dunkit, Cuenta peces and Robo Maro, in addition to the conventional OT sessions. Pre and post-intervention assessments will be based on the Purdue Pegboard Test, the Jebsen Taylor Hand Function Test and the Grooved Pegboard Test.
NCT03186612 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT03186612/
Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis
Randomized, placebo-controlled, crossover, 4-sequence, 4-period, double-blind (participants and investigators), multicenter trial of 3 commonly used medications for treatment of MS-related fatigue (amantadine, modafinil, methylphenidate) versus placebo in fatigued subjects with MS defined by McDonald Criteria.
NCT03185065 — Fatigue in Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/fatigue-in-multiple-sclerosis/NCT03185065/