A Randomized Controlled Trial of Telephone-delivered Cognitive Behavioral-therapy, Modafinil, and Combination Therapy of Both Interventions for Fatigue in Multiple Sclerosis
This clinical trial will compare the effectiveness of 3 treatments for fatigue in Multiple Sclerosis: 1) a commonly used behavioral treatment strategy (telephone-based cognitive behavioral therapy), 2) a commonly used medication (modafinil), and 3) a combination of both therapies. Each participant will receive one of these 3 treatments for a total of 12 weeks. Hypotheses are that, at 12 weeks, treatment with combination therapy will overall lead to greater reductions in fatigue impact, fatigue severity, and fatigability compared to monotherapy, and that comorbid depression, sleep disturbances, and baseline disability level will be important effect modifiers that influence treatment effect and adherence.
NCT03621761 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT03621761/
Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis Patients: A Single-Blind Randomized Clinical Trial
This is a longitudinal single blind randomized trial to test the effects of high compared to low dose vitamin D3 supplementation on cognitive performance at 6 and 12 months, and MRI measures of 12 months duration. A cognitive assessment battery will be administered at baseline, 6 and 12 months. Related clinical data and information on depression and anxiety, lifestyle, and food sources of vitamin D and sun exposure among other variables will also be collected.
NCT03610139 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT03610139/
Role of Advanced MRI Sequences in Differentiating MS and Its Mimics
We aim to evaluate the role of conventional and advanced MRI sequences in: 1. Establishing the diagnosis of multiple sclerosis and differentiate it from its mimics. 2. Predict the prognosis and evaluate the treatment response in the first year of patients with multiple sclerosis.
NCT03608605 — Multiple Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT03608605/
The Impact of Motor Rehabilitation on the Dynamic Properties of the Brain: Towards the Individual Tailoring of Therapeutic Interventions in Multiple Sclerosis Patients
Motor learning can induce significant changes in the human brain through neural plasticity processes, which play a crucial role in the brain functional reorganization in response to external stimuli and/or to pathological conditions. For example, people with multiple sclerosis present motor deficits often associated with cerebral activity alteration. However, whether these brain activation changes contribute to or protect against motor performance deficits still needs to be determined. Moreover, rehabilitation protocols could be designed to obtain efficient brain adaptation to preserve patients' outcome, but consistent data on the real efficacy of rehabilitative procedures are lacking, in particular concerning the rehabilitation effect on brain networks. Therefore, this project focuses on the degree to which imaging measures of functional brain activity can give new hints on the effects of motor rehabilitative protocols in multiple sclerosis patients' performance. Particularly, the investigator's aim is to investigate the effects of upper limb rehabilitation, focused on hand motor function, and the correlation between motor performance and functional magnetic resonance data.
NCT03608527 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT03608527/
Mindfulness Group Intervention for Newly Diagnosed Persons With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) is a chronic neurological disease often diagnosed in a person's 20s or 30s, at a time when most people are starting careers and families. In relapsing remitting (RR) MS new neurological symptoms suddenly develop over hours to days during relapses, and they do not start to resolve for days to weeks. Relapse symptoms may not completely disappear, such that disability accumulates over time. Further, most persons with RRMS will enter a progressive phase years after diagnosis. It is unpredictable when the transition to the progressive phase will occur and how quickly this progression will happen. Thus, receiving an MS diagnosis is a highly stressful event. Persons with MS (PwMS) often suffer from mood symptoms, which can further impair quality of life (QOL). PwMS need support and the skills to effectively cope with the distress that comes with the uncertainty of a new MS diagnosis, as well as to minimize or prevent the onset of negative mood symptoms. One promising approach is mindfulness - a mental state of paying attention with intention, and accepting the present moment as it is without judgment. Scientific evidence supports the use of mindfulness based interventions (MBIs) in other chronic diseases to reduce stress, anxiety and depression, leading to improved physical function and QOL. MBIs decreased stress-related symptoms and the levels of stress hormones in the blood. As such, MBIs have the potential to lessen the negative consequences of stress in newly diagnosed PwMS.
NCT03607773 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT03607773/
Application of the Inhomogeneous Magnetisation Transfer MRI (ihMT) Technique, a New Myelin-specific MRI Technique, in Multiple Sclerosis
The development of in vivo biomarkers sensitive to myelin disruption represents a major clinical need to be able to monitor the demyelination processes as well as the effect of remyelinating therapies in multiple sclerosis. The investigators recently proposed a technique, derived from the conventional magnetisation transfer (MT): inhomogeneous Magnetisation Transfer (ihMT). In preliminary studies, this simple-to-implement and robust technique has shown great sensitivity for evaluating the demyelination processes. The goal of the project is to evaluate the ability of ihMT to measure and describe the spontaneous demyelination and remyelination processes involved in active lesions in a population of patients with MS at the the disease onset.
NCT03600779 — Sclerosis, Multiple
Status: Recruiting
http://inclinicaltrials.com/sclerosis-multiple/NCT03600779/
The Effects of Extremity and "Core" Muscles Strength on Walking and Sit-to-Stand Performance in Patients With Multiple Sclerosis
Muscle weakness, which is one of the most common symptoms in patients with MS, limits the activities of daily life activities of patients by causing balance and gait disturbance. Lower extremity muscle strengths of MS patients are reported to be weaker than healthy individuals. Broekmans et al. showed that the weakness of the knee flexor and extensor muscles in patients with MS caused a decrease in walking distance and they are important determinants of walking capacity. The effects of the endurance and strength of core muscles, as well as the extremity muscles, are important on physical performance. The weakness of the extremities and core muscles in MS patients also affects the sit-to-stand performance negatively as well as a decrease in walking speed and capacity. In this study, it was aimed to investigate the effects of extremity and core muscle strength on walking and sitting-up performance of MS patients.
NCT03597451 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT03597451/
Effects of Neurodynamic Interventions to Multimodal Physical Therapy in Patients With Multiple Sclerosis
A randomized, parallel-group, clinical trial will be conducted to compare the immediate effects of the inclusion of a neurodynamic intervention into a multimodal physiotherapy program on pressure pain sensitivity, pain and manual dexterity in patients with multiple sclerosis
NCT03595631 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT03595631/
Fecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple Sclerosis: A Phase 1b Clinical Trial to Evaluate Feasibility, Safety, Tolerability and Effects on Immune Function
In this Phase 1b open-label prospective clinical trial, patients with relapsing-remitting MS will undergo FMT of FMP30 (donor stool) via colonoscopy and immunological efficacy endpoints will be assessed at various time points. The active phase of the study will continue for 12 weeks post-FMT with safety and biomarker (engraftment) follow-up for 48 weeks. A parallel observational control arm of MS patients who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures. The study duration for the Observational Control Arm is 12 weeks.
NCT03594487 — Relapsing Remitting Multiple Sclerosis
Status: Active, not recruiting
http://inclinicaltrials.com/relapsing-remitting-multiple-sclerosis/NCT03594487/
The Relationship of Cognitive Functions to Physical and Personal Factors in Patients With Multiple Sclerosis
Approximately 65% of multiple sclerosis (MS) patients appear to have problems in their cognitive function. Long-term memory is one of the most frequently affected functions in MS patients. Many factors play a role in the deterioration of cognitive functions because of many symptoms of MS. The aim of this study is to investigate the relationship of cognitive function with physical factors such as balance, functional exercise capacity and personal factors such as fatigue level, mood, sleep quality in patients with MS.
NCT03594357 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT03594357/