Cognitive rehabilitation in multiple sclerosis

Other measures (1)

Background and study aims Multiple sclerosis (MS) is a relatively common condition in the UK. Often symptoms begin in early adulthood and can lead to physical disability. Although less common, another symptom that may be associated with MS is difficulty with cognition (memory). It has become increasingly recognized that if present, these problems often relate to planning, information processing speed as well as memory. This study aims to understand why some individuals with MS experience memory problems, if certain forms of cognitive training can improve memory in these individuals and how if any this reflects changes in magnetic resonance imaging (MRI) brain scans. Who can participate? Patients diagnosed with MS. We know that some patients are aware of some memory problems and difficulty with planning as the condition progresses. We also know that some patients with MS have subtle memory problems that they may not be aware of and may not impact upon them. These are often only picked up on detailed examination. However, through studying patients with all levels of memory problems we may still learn much about cognitive problems in MS and for this reason all patients with MS may potentially be screened for memory problems and be considered for participation. What does the study involve? If you do decide to take part, we will first ask you sign the relevant consent forms. You will again have the opportunity to ask further questions. The initial step is to perform a brief cognitive assessment to see if you have any memory difficulties on formal testing. This will be carried out in the clinic and takes approximately 15 minutes. The tests will be of varying difficulty. There is no pass or fail on the tests, they are just to screen for the presence of any cognitive difficulties and establish a baseline before any cognitive rehabilitation takes place. It should be emphasised that all individuals will find certain aspects of the testing difficult at times. At this stage, if there is insufficient evidence of significant memory problems you would not be asked to participate further in the study. If we detect cognitive difficulties above a certain level during these tests you would be invited to participate in the remainder of the study. At this point you will undergo a brief brain examination in order to ascertain if there are any physical disorders that might make participation in the study difficult. You will then be asked to complete a number of questionnaires relating to mood, fatigue and daily function. This will take about 15-20 minutes. If it is more convenient, the questionnaires may be completed when attending for the first MRI scan. You will then be invited to have a MRI brain scan. This will be performed in the weeks following enrolment but before any training occurs. You will most likely have had a MRI scan previously as part of the diagnostic work up for MS. You will then be randomly allocated to one of two groups. One group (the active treatment group) will receive cognitive training on a home PC. This will involve three 45 minute sessions per week for 6 weeks. The other group will be the control group and while there will not be the home based cognitive training, you will receive a series of DVD’s to watch for the same period for 6 weeks. This is to see if the cognitive training makes any difference to outcomes compared to the control group. Following completion of the 6-week study period, you will be asked to undergo MRI scans on two further occasions to examine if any change can be noticed on MRI. While attending for MRI you will be asked to undergo the same cognitive testing and complete the same questionnaires as before. The first of these MRI scans will be soon after completion of the 6-week study period and the second scan performed 3 months later. You will therefore have a total of three cognitive examinations as well as three MRI brain scans and you will be asked to complete the questionnaires on three separate occasions. What are the possible benefits and risks of participating? We cannot promise the study will improve your memory, but the information we get may help improve our understanding of some of the cognitive difficulties that individuals with MS may experience. It is hoped that this study will provide evidence for the effectiveness of the training to help improve memory in patients with MS who suffer from memory problems. The MRI scanning may help us better understand the areas involved in memory and devise techniques to earlier identify patients who may go on to develop memory difficulties. Participants will have to devote some of their personal time towards taking part in the study, in particular participants will have to devote a dedicated period to undertaking the training at home as well as undergoing three MRI scans. Taking part in this study will not affect the usual standard of care that you receive. All techniques that we use in the study are known to be non-invasive and safe. MRI has been used in clinical practice and research for over 20 years and is not associated with any long term side effects. MRI does involve a high strength magnetic field and therefore steps will be taken to ensure you have no metallic objects in your body as this could be dangerous. Very rarely during MRI scanning an incidental abnormality is detected. Under these circumstances an expert opinion may be sought with regards to the images. This is only done in the cases where it is believed there is a clear need and may require images and personal details being entered onto information systems owned and operated by Brighton and Sussex University Hospitals NHS Trust (BSUH). Following this, medically trained members of the research team will discuss the abnormality with you and you would be referred to the appropriate individual. Where is the study run from? The study is based in Sussex. At this stage we expect to recruit patients with MS who are attending Brighton and Su