Active clinical trials for "Multiple Sclerosis, Chronic Progressive"

This study is a pilot trial to evaluate the effects of supported treadmill walking in patients with primary progressive multiple sclerosis (MS) on functional and psychosocial outcomes. Patients will exercise three times per week over the course of 6 months and will be evaluated at baseline, 12 weeks and 24 weeks into the program. Follow-up testing will also be conducted 12 weeks after participants have stopped exercising to determined the lasting effects of the intervention. The investigators hypothesize that supported treadmill walking will be effective at improving physical physical function and psychosocial outcomes in patients with primary progressive MS.

Title: Behavioural Activation for Low mood in Multiple Sclerosis The study will be sponsored by the University of Lincoln, indemnity will be provided by U M Association Limited. Depression is highly prevalent among people with Multiple Sclerosis (MS). More specifically, as the disease progresses, people are more likely to develop depression and there is limited evidence of suitable interventions in this group. There are few studies that investigate the most appropriate duration, delivery modality, or individual adaptations for therapy for people with secondary progressive Multiple Sclerosis. This is problematic because continued reduction in physical and cognitive ability, combined with greater incidence of depression, may make accessing and engaging in therapies difficult. Behavioural activation is a technique used as a component of psychotherapy. Behavioural activation aims to reduce behaviours that maintain or exacerbate depression by promoting counteracting behaviours, using strategies such as activity monitoring and scheduling. However, there is no research looking in-depth at the underlying processes. Therefore, this research aims to explore the feasibility and efficacy of behavioural activation by: Adapting an existing behavioural activation manual into five sessions, suitable for people with secondary progressive MS. Examining if behavioural activation is followed by phases of change that are considered to predict later therapeutic outcome and to determine whether behavioural activation accounts for changes observed. Up to ten participants from Nottingham University Hospitals will be recruited. Participants will be briefed on the research aims and consent will be obtained before commencing the intervention. The project will follow a multiple baseline single-case experimental design. Participants will complete weekly outcome measures that aim to observe low mood, quality of life, and adherence to behavioural activation and alignment with individual's values. Following five to six contact sessions, participants will take part in a follow-up interview. Participants will then be debriefed.

What is the purpose of the study? People with Multiple Sclerosis often say that they feel less support is available after they are diagnosed with Secondary Progressive Multiple Sclerosis, compared to before they received this diagnosis. People sometimes experience a lessening of support, despite their physical symptoms becoming more severe from both professionals and those in their personal lives. The purpose of this study is to see whether providing some telephone support to those who have recently received a diagnosis of Secondary Progressive Multiple Sclerosis is experienced as helpful and is possible to do practically. This study will help the investigators understand which type of support may be helpful for patients in the future and may pave the way for larger studies and changes to NHS provision. Who is it for? Participants will be those who have transitioned recently (within the last year) to Secondary Progressive Multiple Sclerosis. The investigators are inviting 40 participants to take part. What will happen to participants if they take part? Participants will be asked by their Neurologist or MS Nurse to take part in the study and will provide written consent to be contacted, which will be stored by the research team. Their details will be passed to the study team at the University of Nottingham, who will telephone the participant within a week to tell them a bit more about the study and ensure they are suitable for the study by asking them some questions. Following this, the participant will be sent some paper or online questionnaires to complete and return. After this, the researcher will visit the participant face to face to introduce themselves and answer any questions they may have. They will also tell the participants what "group" they have been randomly put into. There are two groups. Those in the first group would be asked to commit to receiving a 30 minute support phonecall each week for five weeks in addition to any usual care, and the second group will receive their usual NHS care. The support phonecalls will draw from techniques used in a type of psychological therapy (acceptance and commitment therapy). All the phonecalls can be done whilst the participant is at home or in a quiet place of their choosing. After this, both groups will fill in some more paper questionnaires eight and twelve weeks after the start of the study. The investigators expect that participants will be involved in the study for around 4 months. After the study, participants will also have the opportunity to feedback how they experienced being a participant in the study. Their responses will help the researchers understand their experience, and help them use this to think about how to adapt similar studies in the future.

Idiopathic inflammatory disorders of the central nervous system include various disorders of which multiple sclerosis is the most common. Besides multiple sclerosis, other distinct disorders including for example anti-AQP4 (aquaporine-4) and anti-MOG (Myelin oligodendrocyte glycoprotein) NMOSD (Neuromyelitis optica spectrum disorder) have been well characterized and are now known to be distinct from MS. some patient belonging to MS spectrum have recently being characterized but unusual MRI findings have mimicking inherited leukoencephalopathies and leukodystrophies. Whether these patients with atypical phenotype represent a separate disease distinct from MS or belong to MS spectrum is not clear. The objectives are to evaluate a series of 15 patients with atypical forms of MS using non-conventional MRI techniques and biological biomarkers (serum neurofilaments light chain) and to compare them with classical MS patients (15 relapsing remitting patients and 15 progressive patients) and 15 controls. the hypothesize is that these patients with atypical MS have a more severe neurodegenerative process.

Multiple sclerosis (MS) is characterized pathologically by demyelination, axonal loss, and glial scar formation. Clinically, most patients have a relapsing-remitting course of MS (RRMS) that over time may become progressive without remissions - a secondary progressive MS (SPMS). About 15% of patients have a progressive course from onset which is called primary progressive (PP). Currently, there is no approved treatment for PPMS and for SPMS only therapy with mitoxantrone showed mild effect. Thus, more effective therapies need to be developed for treatment of SPMS and PPMS. Methotrexate (MTX), an anti-metabolite, has been in clinical use since 1948 when it was found to produce temporary remission of acute childhood leukemia. There are accumulating evidences that in progressive MS patients there are follicular lymphoid structures in the meninges and in the Virchow-Robin spaces. Therefore, intrathecal therapy may target the pathological follicular lymphoid activity. The safety of intrathecal MTX (ITMTX) has been demonstrated by its widespread use in treating lymphoproliferative diseases and leptomeningeal metastases. Sadik et. Al. reported about the feasibility and safety of using intrathecal methotrexate (ITMTX) as a treatment for unresponsive patients with progressive forms of MS. In their open label study they found that ITMTX may have a beneficial effect in progressive forms of MS and that it was well tolerated with no serious adverse events. The investigators aim is to evaluate the efficacy , safety and tolerability of intrathecal methotrexate administration every 3 months in progressive 30 patients with progressive MS. The investigators will evaluate clinical, laboratory evaluation of the blood and cerebrospinal fluid as well as the MRI scans of the participants. Each patient will be treated 4 times for 1 year with the option to continue for another 1 more year with the same protocol.

Due to their ubiquitary distribution, smartphones might serve as an easy way/ possibility to use feedback mechanism in an app-based intervention program to increase physical activity in Multiple Sclerosis (MS) patients. Internet based cognitive-behavioral interventions have been explored as effective in the last years. In addition, smartphone-based mobility assessment and intervention might be a promising approach in other MS types and for real-life mobility assessment in observational and interventional trials. The aim is to investigate the impact of a smartphone based information and feedback program on physical activity in a 3 months, randomised waiting-group controlled trial of 40 progressive MS patients.

Multiple sclerosis (MS) is a neurological condition which is a common cause of disability in young people. It is thought to be an autoimmune condition, where the body's immune system begins to attack itself. The cause of MS is unknown but is thought to be a mix of genetic and environmental factors. There are treatments available for early stages of MS, but the later stage known as Secondary Progressive MS (SPMS) has no current treatment. Statins are a safe treatment traditionally used to reduce cholesterol levels. However, statins also have other effects which could reduce the progression of SPMS, such as effects on the immune system and circulation. A recent study (Chataway et al., 2014) showed that treatment with high-dose simvastatin, a type of statin, reduced the progression of SPMS but no effect on the immune system was seen. It is possible that simvastatin does not treat the immune system but improves how the blood and blood vessels in the brain work in this disease. The purpose of the clinical trial is to test how Simvastatin (80mg/day) may slow down disease progression in people living with SPMS compared to placebo (dummy pill). Participants will receive either Simvastatin or placebo and will be asked to take 2 tablets daily, for up to 17 weeks.

Fatigue is one of the most common and debilitating symptoms of Multiple Sclerosis (MS). Exercise is suggested as a way to improve fatigue, but it is not clear what the effects of exercise are on fatigue - especially in people with progressive MS. Therefore, this study aims to test the feasibility of a tailored exercise programme to help improve fatigue in people with progressive MS. To do this people with progressive MS who are experiencing fatigue will be randomly allocated to receive either a tailored exercise programme, a standard exercise programme, or their usual care. Both exercise programmes will be 8 weeks long and require participants to attend Falkirk Community Hospital twice a week. The standard exercise programme involves a moderate intensity interval training session using a stationary exercise bike. The tailored exercise programme is similar to the standard exercise programme, as participants will be prescribed the same type and duration of exercise; however, the difference between the 2 programmes is that the intensity of exercise performed during each session of the tailored exercise programme is dictated by the participant's level of fatigue. Participants will complete an exercise test, walking test, and questionnaires relating to fatigue, quality of life, depression and anxiety, sleep quality, and cognition before and 1 week after completing the exercise programme.

The purpose of this study is to compare the efficacy and safety of andrographolide 140 mg administered twice a day orally versus a placebo as a modifying treatment of the disease in patients with the progressive forms of Multiple Sclerosis (MS). The principal outcome is to determine the efficacy, of andrographolide in retarding the progression of brain atrophy in patients with progressive forms of MS.

Multiple sclerosis - MS - affects 1.3m people worldwide, costing the European Union economy €9 billion/year, through both direct and indirect consequences of progressive disability. Despite the usual relapsing-remitting presentation, over 80% of patients develop progressive disability; 40% require a wheelchair within 10 years of diagnosis. At present, there are no treatments that reverse, halt or even slow progressive disability in MS. The investigators recently completed one of the first feasibility/safety trials in the world of reparative bone marrow cell therapy in 6 patients with longstanding MS (www.nature.com/clpt/journal/v87/n6/full/clpt201044a.html). Safety was confirmed, and intensive repeated tests on the patients measuring nerve conduction in various pathways in the brain and in the spinal cord showed statistically significant improvements at 12 months in every patient. While highly preliminary and involving only a very small number of patients, these results at least raise the possibility of a significant (though very partial) underlying repair effect within the damaged nervous system. The investigators believe this urgently requires further testing - both to accelerate benefit for patients, and to begin improving therapeutic efficacy. The investigators therefore propose a programme of translational and clinical stem cell research, aiming (1) to continue translation with a phase two controlled trial of bone marrow cells in patients with longstanding MS; and (2) to explore in parallel the potential mechanisms of action, by studying bone marrow cells from treated patients and control subjects, aiming to establish which of the various relevant bone marrow subpopulations contribute to efficacy, and which particular reparative mechanism(s) are important. The investigators hope these studies will not only confirm the therapeutic benefit of this approach, but also provide the basis for improving the magnitude and impact of this novel and exciting treatment modality.