A lecture from the MS Society


A free lecture as part of the MS Society’s Stop MS Appeal will take place virtually on Wednesday 2 June from 6.30pm. The lecture is for anyone who is keen to find out about research the MS Society is funding and also the new exciting trial that could transform the way treatments for Progressive MS are tested. 

The Stop MS Appeal

Everyone diagnosed with MS knows that their condition is likely to progress, potentially impacting their ability to simply walk, talk, think, eat or see. For those with the primary or secondary progressive stages of MS, it is currently impossible to repair the damage once it’s been done. 

Put simply, the Stop MS Appeal aims to raise £100 million to find treatments for every single person with MS. Today, in 2020, we have treatments that can reduce relapses and slow the worsening of disability in relapsing forms of MS. But that is not enough. We want to stop MS in its tracks, and halt progression, for everyone. 

We don’t have to imagine a future where nobody needs to worry about their MS getting worse, we can see it. And a major strategic investment could unlock breakthroughs that are on the horizon. By 2025 we plan to be in the final stages of testing a range of treatments for everyone with MS.

The Lecture 

We are excited to announce that the lecture will be presented by Professor Jeremy Chataway, National Hospital for Neurology and Neurosurgery and UCL Queen Square Institute of Neurology, and Professor Max Parmar, Director of the MRC Clinical Trials Unit at UCL, lead investigators of our ground-breaking new multi-arm, multi-stage trial, Octopus, that will transform the way we test treatments for progressive MS.

Join Professors Chataway and Parmar as they explain our Octopus journey so far – from bringing together experts from different fields to plan the trial, developing Octopus’ revolutionary design and getting the trial ready to open to participants later this year.

After the lecture, there will be a Q&A panel session with our esteemed Stop MS Scientific Ambassadors, where guests will be invited to ask any questions they may have.

Interested?

You can register to attend here: https://stopmslecture.eventbrite.co.uk (please note, places are limited.)

For more information please contact Hettie.tetteh@mssociety.org.uk.

Fatigue and MS

Maggie, a participant on the MS Register recently reviewed a scientific paper for us. It was published in ‘Multiple Sclerosis and Related Disorders’ and was created in collaboration between Birmingham University and the UK MS Register, looking at Fatigue and MS.

High levels of fatigue were reported by 56.4% of participants

Fatigue is a common problem for MS patients.

How the management of fatigue in MS patients is conducive to a better outcome in the treatment of mental and physical problems affecting day to day living.


Fatigue is a debilitating symptom of MS and is potentially caused by central nervous system lesions and inflammation leading to pain and poor sleep. The side effects of medications may also add to the problem and lead to the general deterioration of the ability to function day to day.

Between September 2016 and May 2018 fatigue was assessed as it affected 3398 participants in the U.K. MS Register questionnaire on the subject. The benefits of having a large number of people willing to answer questions on all aspects of their health in relation to fatigue are apparent and show how the U.K. MS Register can help the relevant professionals in their research into MS.

The study aimed to examine differences between personal experiences of fatigue in MS patients, who provided information to the U.K. MS Register and answered questions for the Fatigue Severity Scale. high levels of fatigue were reported by 56.4% of participants and higher levels of fatigue were associated with higher levels of anxiety and depression among other variables. 69.5% of the participants were female and 56% had Relapsing Remitting MS. 56.4% of the respondents experienced high levels of fatigue. Fatigue affects the quality of life in many MS patients and influences walking ability and the ability to do household tasks. It causes depression and anxiety and mood disorders. Like many MS problems, fatigue is not a visible symptom of itself. It is reflected in the problems which are visible to others, but the effect is often exacerbated by the impression that the patient is not trying hard enough, a common problem which leads to mood swings and anxiety and a draining depressive state. A reduction in social interaction and participation is also a result of fatigue.

The study posits that a personal intervention tailored to a patient’s specific needs would have positive health benefits. Some patients would respond well to an exercise programme, others to psychological support.




About me

My name is Maggie and I have Secondary Progressive MS which is thankfully not active at present and has stabilised to a problem with spasticity and some very small problems with brain function no doubt caused by a multitude of brain lesions. Management of fatigue has involved a personal imposition of routine and a determination to keep to that as regards sleep and meal times.

The scientific paper that was used for this report was:
Fatigue and fluctuations in physical and psychological wellbeing in people with multiple sclerosis: A longitudinal study.
By Jet Veldhuijzen van Zanten , Michael R Douglas, Nikos Ntoumanis  https://pubmed.ncbi.nlm.nih.gov/33176231/


Monitor your MS and share with your health care team

See your Feedback on the MS Register.

On the ‘My Profile’ page make sure you have choosen the option to ‘see my feedback’

Then on ‘my Hub’ page you will see ‘My feedback report’ on the the top right.

You can down load it to a pdf and print or send it to your Health care team if you need to.

 

Update for Fatigue and Physical Function Study

First of all, a big thank you for your participation in the Merck study, and for sticking around for the last few months until now!

As we get into the final phase of data collection, we thought of sharing some important updates about the study with you.

  • First, this study has made an enormous contribution to research into new MS treatments. The two new questionnaires developed and tested in this research are now included in two Phase III multiple sclerosis trials – EVOLUTION I & II. Specifically, fatigue symptoms and physical function are being assessed in these trials as “secondary endpoints”, based on the new questionnaires.
  • Second, Merck’s collaboration with other companies and health authorities responsible for approving new medicines in the US – the FDA, through the Critical Path Institute PRO Consortium, continues. Specifically, this initiative is seeking to get the two new questionnaires (fatigue and physical function) to be accepted and approved by the authorities as standard clinical trial outcomes. This would encourage other companies and research to evaluate how treatments directly impact fatigue and physical function, which represent outcomes that are important for people with MS.  In June 2020, the consortium received new funding from the FDA to fast-track work focusing on the PROMIS physical function questionnaire.
  • Further, we continue to present results from this work at various scientific and international conferences. We are particularly excited to be presenting at the European Committee For Treatment and Research in Multiple Sclerosis (ECTRIMs) Annual Congress this September. This is the world’s largest professional organization dedicated to the understanding and treatment of Multiple Sclerosis. Of course, we’ll be sharing with you the posters and links in due course.
  • Finally, with the current study winding up this autumn, we are already back to the drawing board to design and plan further research, to be initiated in the near future. Watch this space.
  • I hope you and your family stay safe in these unusual times.

 

MS and Mood during the COVID-19 pandemic

Researchers from the Nottingham MS Research Group are working with colleagues at Imperial College London, Swansea University and the UK Multiple Sclerosis Register to examine the effect of COVID-19 on people living with MS.

The project includes a sub-study to explore how COVID-19 is affecting the mood and psychological wellbeing of people with MS. This is important because this kind of pandemic, and the associated loneliness caused by isolation, can lead to future mental health problems for many. As it is acknowledged that high levels of mood problems can be associated with MS relapses, the research teams want to urgently track people’s mood, and find ways of helping them deal with these problems.

While during the initial few months of the COVID-19 pandemic, much research attention focussed on the physical aspects of the disease, with the advent of the lockdown and all its consequences, it became clear to us as clinicians and researchers that people’s mental health was likely to be affected. Therefore, our study was put together very quickly to understand how people with MS were experiencing life during the pandemic in terms of their mood and their lifestyle.

The MS-COVID-19 psychological wellbeing study focuses on (i) mood (anxiety, depression, and trauma), (ii) lifestyle issues (how people’s diet, exercise, alcohol consumption and smoking behaviours had changed over the course of the pandemic), (iii) work issues, and (iv) social support. We have over 1800 people with MS complete the survey so far, and we would like more people to tell us how they have been feeling. If you have MS, please click here to log on and complete the questionnaire: ukmsregister.org/login 

To make sense of our data, we are also reaching out to the general public (who do not have MS) to complete the same questionnaire, so that we can look for similarities and differences in how those with and without MS are experiencing life during the pandemic. We would like to urge people without MS to complete our brief questionnaire, by following this link: https://redcap.ukmsregister.org/surveys/?s=HX3HPMRJLP 

 

COVID-19 and MS

The MS register and the MS Society are asking people with MS to tell us more about the impact the current coronavirus pandemic is having on their lives. Over 3,500 of you have already completed a survey asking some questions about your treatment and changes you may be making to your behaviour. We would also like to know about how you are feeling within yourself, the impact on your employment, finances, and access to appropriate care and support. As well as asking what support you might need right now.

Answers you provide to this survey will help us continue to make the case with the government and NHS for crucial care and support for our community. Over these past weeks we have been in constant communication with our medical advisors, government officials, other charities and decision makers to ensure that the needs and voices of people with MS are considered. We have been working hard to ensure that people can get the food, medications, care and financial support they need, and that the information people with MS are receiving is clear and relevant. We continue to work hard to ensure the best possible outcome for people with MS. What you tell us through this survey will give us crucial information to do so.

We also want to make sure that we are providing the information, services and support that you need at this time. You may be at home but you are never alone. Calls to our helpline have been up over the past few weeks while our community works out what the new situation means to them. Although our in-person events have been paused for the moment, we have introduced a number of virtual services and events. We have been doing weekly webinars on managing your MS. We have also introduced a ‘keeping in touch’ service to ensure people who would like social contact can receive regular phone calls – just to chat. As always, we want to make sure that the services we are providing are relevant to what you need right now. By filling out this survey you are helping us stay in touch with the needs of our community, and continue to provide those services and support that are needed.

People with MS in the UK are providing vital information on Covid-19

The MS Society is looking for people with multiple sclerosis (MS) to provide vital information through the UK MS Register on how coronavirus is affecting them.

MS damages nerves in the body and makes it harder to do everyday things, like walk, talk, eat and think. Having MS alone does not increase your risk of getting Covid-19, but many people with MS are at an increased risk of infection, or severe complications.

Thousands with the condition are classified as extremely vulnerable, and have been asked by the Government to self-isolate for a period of 12 weeks.

The UK MS Register team have put out a first – ‘baseline’ questionnaire on Coronavirus (COVID-19) and MS to collect data on how coronavirus is affecting People with MS (PwMS), and to learn if people on Disease Modifying Treatments (DMT) are really more susceptible, what advice should be given and to drive future recommendations.

The team is also trying to capture how PwMS feel about the current situation, to understand what sort of information and support PwMS have been given, and if behaviour has changed as a consequence. The type of information provided by PwMS could help the way COVID-19 is dealt with, and inform how future pandemics may be approached.

Rod Middleton, Programme Manager of the UK MS Register at Swansea University Medical School, said: This study is important for people with MS so that we can understand how pandemics like this can affect them and hopefully learn how to manage this for the future. The Register has a unique ability to model many of these factors as we have longitudinal data from PwMS in some cases going back 8 years. We can see in great detail how new factors impact on all aspects of peoples MS, their quality of life, fatigue and mood.

Dr Susan Kohlhaas, Director of Research and External Relations at the MS Society, said: “More than 130,000 people live with MS in the UK, and we are asking every one of them to join this study to help us understand more about Covid-19. There’s so much we don’t know about this virus and only real world data will help us change that.

“This is a worrying and uncertain time for all of us, but many people living with MS are especially vulnerable, and this study will allow us to support them as best we can.

During the first 24 hours alone, 1,174 people with MS completed the questionnaire – including 11 with potential cases of coronavirus – but more people are needed to help researchers fully understand the virus and its impact.”

Professor Richard Nicholas is co-leading the study, which is run by the UK MS Register. He says: “MS is unpredictable and different for everyone, and we understand some people are at greater risk from coronavirus than others – such as those who are taking MS treatments that lower the immune system. But all the current advice is based on our understanding of how treatments work, and we urgently need more data to establish the facts. For example, we anticipate there could be some treatments that actually lower a person’s risk level of contracting the virus, but can only confirm this through research.

“This simple online survey can help us identify when and how symptoms of Covid-19 occur in people with MS, so we can provide the best possible guidance on treatment and better support for them in the future.”

Responses also reveal changes in behaviour in response to Covid-19, and indicate that 90% of people with MS in the UK are currently in self-isolation.

One reason this research must be conducted now rather than after the crisis has peaked is to avoid the issue of recall bias, where memories are affected by any new information learned about how the virus.

Study co-lead Professor Nikos Evangelou, explains: “As testing becomes more widely available and we know who did and didn’t have the virus, we’ll be able to look back at our findings and determine whether different treatments have a negative or positive impact on the risk of getting Covid-19, or the severity of symptoms. Every response counts.”

The MS Register– an ongoing study based at Swansea University, and funded by the MS Society – will publish regular updates of their results so clinicians and people with MS can benefit from the findings, and make better decisions about treatment throughout the pandemic.

Anelma Beech, 48, lives in North Wales and has relapsing MS. She has signed up to the MS Register study, and says: “I’m isolating at the moment because I’m in the high risk group, and have not been able to see anyone. It’s tough, but while we’re all stuck indoors we can do something really valuable, and tell the experts how coronavirus is affecting us. If we don’t, they can’t do anything about it. And the more information they have the better equipped they’ll be to deal with problems in the future. It’s a scary and uncertain time but this is a really important contribution people with MS can make to help make things a bit clearer.”

To take part, people with MS can visit https://ukmsregister.org.

For the latest information on how people with MS are affected by Covid-19 visit mssociety.org.uk/coronavirus

THE IMPACT OF COVID-19 IN MULTIPLE SCLEROSIS: A SUBSTUDY OF THE UK MS REGISTER

This is the Blog published on the Barts Multiple Sclerosis Research Blog by The UK MS Register Clinical Lead, Dr Richard Nicholas.

We need to understand more about COVID-19 urgently, and you can help.

COVID-19, the coronavirus infection, is devastating the health and jobs of millions around the world, and is now in increasing in the UK with a major impact on all of our lives. People with multiple sclerosis (pwMS) are a susceptible group both due to the impact of the disease but also as a result of taking disease modifying drugs (DMDs).

There are a wide range of DMDs that reduce the ability of the immune system to respond to normal challenges, such as viruses, to varying degrees. Advice has been developed and released all over the world (including this blog) in terms how to respond to the potential immune impairment from DMDs. However, there is fine balance between immune suppression to contain MS and the potential damage that immune suppression might allow. Much of the advice is based on what we know so far about DMDs, but we need to know if this advice is correct.

We need to understand how pwMS are affected, but there are a number of real challenges that we have not as yet resolved:

  • At this moment in time we can only measure if people have an active virus present at the time of the test.
  • We cannot as yet measure if someone has had the infection in the past and has developed an immune response. Hopefully this test will be available in the next month.
  • Currently, we do not have testing kits available in enough numbers to test everyone and in the UK, and at this time, only people admitted to hospital are being tested.

This means that understanding the true numbers of people who get the virus and have no symptoms or mild symptoms is not possible. Therefore, we get a distorted view of the impact of COVID-19 in pwMS as we only know about those who are severely affected. The problem with trying to understand if someone had symptoms once we do know if they had an infection is called ‘recall bias’ – people selectively identify symptoms in retrospect. To get over this problem we need to collect information prospectively that is before people get the virus and as they recover.

This study aims to recruit people now when they are well or if they have recently had the virus, and then follow what happens to them regularly over the next few months. This will enable us to identify when symptoms occur and what their impact is.

Once further testing becomes available, we will be able to understand how many people were truly affected and also determine whether DMDs have a negative or positive impact on the chance of getting the virus and whether they affect the severity of the infection.

To collect these data, we are using the UK MS Register based at Swansea University and funded by the UK MS Society as a platform. The UK MS Register has been running since 2011 and has signed up more than 15,000 pwMS and collects details of each person’s MS and asks them to complete participant reported measures regularly. The UK MS Register works in collaboration with 49 UK National Health Service Trusts with an MS Service around the UK. We need pwMS to register and complete a set of questionnaires and update details of their MS. These questionnaire sets will be repeated every two weeks over the next few months. We also want to contact their clinical team and be able to get the details of their test results when it is eventually done.

Figure 1. Rolling update 07.00 21st March 2020

We will generate rolling updates of these data for pwMS and healthcare professionals to inform and support decision-making about the best decisions about treatment and approach in the context of COVID-19. We have already started collecting data and as of 07:00 on the 21st March 2020, 1818 pwMS have already taken part, but need more people with MS to take part to get useful results – most recent update (Figure 1).

To take part please go to https://ukmsregister.org and sign up to the UK MS Register, or log back in if you are already registered. Every response helps.

Parallel to this survey, we are asking neurologists and MS professionals to report anonymously if any of their patients in their centres had COVID-19. This can also be accessed at https://ukmsregister.org.

By studying the results from the two surveys, we will get a clearer picture of how the pandemic affects people with MS and update COVID-19 guidelines based on real data.

Exciting Updates for The Ongoing Merck Study

In autumn of 2018, we launched a study in collaboration with Merck Healthcare KgaA, which seeks to provide a better understanding of the burden associated with MS symptoms and day-to-day impacts and how best to assess these.

In our September 2019 newsletter/update, we share with you that two new patient-friendly self-assessment questionnaires for fatigue and physical function had been tested and validated. These are already included in planned MS clinical studies, supporting research on new MS therapies.

The Merck study is still ongoing until November 2020, with the 18-month assessment window currently open. As the study continues, the research team has already started with analysis of data. Results from analyses of data collected as of October 2019 were presented at two conferences, the International Society of Quality of Life Research (ISOQOL), and the PROMIS Health Organization (PHO), in San Diego, California, in October 2019.

 

Here are links to the two posters that were presented.

PHO_PROMIS_MS-Fatigue-v2.1-22102019

ISOQOL_PROMIS_MS-PF-v1.0-20102019

As mentioned in our autumn (2019) update, Merck is participating in an initiative, the C-PATH PRO Consortium MS Working Group, alongside other pharmaceutical companies, and other organizations, to standardize assessments of fatigue and physical function in clinical trials used to test new MS therapies. Data from the current study are being used as key evidence supporting discussions with the US Food and Drug Administration (~the government agency responsible for evaluating and approving new drugs in the USA), as part of the initiative. If the initiative is successful, we expect to see an increase in trials including assessments of fatigue and physical function outcomes as important (i.e. secondary) outcomes, based on the new PROMIS questionnaires.

Once again, thank you for your continuous contribution to this important research.

 

Coronavirus (COVID-19) and MS

We understand that you might be feeling worried about the Coronavirus and your MS.

Here is a general information page with plenty of useful links for advice and suggestions here https://www.ukmsregister.org/coronavirus 

We have put a questionnaire on your Hub Page because it is very important to collect data on how Coronavirus is affecting People with MS. Additionally we would like to learn if people on disease modifying treatments are really more susceptible and what advice we should give. We believe that this is a very important study all PwMS should take part to drive future recommendations.

In addition, we are trying to capture how you feel about the situation now, what sort of information and support you have been given, and whether you have changed your behaviour. This type of information could help the way this virus is dealt with and indeed how situations like this are approached in the future.

It is important that as many patients that are currently well fill in in the questionnaire as they will help interpret the results of those feeling unwell.
The following questions will take about 7 minutes to complete. We would also really like you to make sure if you can, that your other details (on the left hand side of the Hub screen) are up to date and accurate. Please check especially that you have recorded any DMT you are currently on and if you have any other illness.

We also want to monitor what is happening with the Coronavirus. We will keep this questionnaire open for you to return to if anything changes, and we will also send email reminders to you to log if something changes. We may also send follow up questionnaires over the course of the next few weeks/months.

We will be reporting back regularly with results to you, the MS clinics and national and international organisations

Thank you for helping us monitor how people with MS are coping with and reacting to the virus.

If you are worried about your MS and the Corona Virus, please contact your GP, Neurologist or MS Team.

If you suspect that you have Coronavirus, please follow the NHS and government advice here https://www.nhs.uk/conditions/coronavirus-covid-19/
If you do get a confirmed diagnosis, please log back in and let us know.

Stay safe everyone

 

The Hidden Costs of multiple sclerosis (MS) 

New research has shown for the first time what people with peoplewith MS have had to spend themselves to maintain an independent standard of living.

The study from Swansea University Medical School has found that people with MS and their families are having to fund up to 75% of non-medical costs from their own pockets. Previous research in this area has only looked into the cost of drugs and overnight stays in hospital. The cost from people’s own pockets has not been looked into in any detail before.

What is Multiple Sclerosis? 

Multiple Sclerosis (MS) is an autoimmune neurological disorder that is the commonest cause of disability in adults of working age.  MS affects more than 120,000 people in Britain and around 2.5 million people worldwide. The symptoms of MS have a profound effect on people’s day to day lives due to the physical and cognitive effects of the disease that can lead to loss of employment and a profound personal impact. MS is a particularly harsh condition, as can affect people just at the point that they are typically starting to really flourish in their careers and start families. Costs in MS have focused on the high cost of treatments that mainly target early MS and the personal costs have not being looked at in detail.

The Study 

The UK MS Register is a research database operated by Swansea University and funded by the MS Society. Data is routinely collected from people with MS and from their doctors and nurses both online and through their specialist. It’s one of the largest databases globally with real world data in MS. In partnership with Sanofi a survey about the cost of MS both to society but also to the person was sent to people with MS by the UK MS Register. Five hundred and thirty seven people with MS completed the survey over 6 weeks and this was combined with data that the person had already given to the MS Register. This included: the severity of their disease, type of MS, age, gender, employment status and their ‘normal’ quality of life.

What did we find? 

We divided costs into medical and non-medical. Medical costs include: admissions to hospital, rehabilitation, blood and other tests such as X-Rays and MRI scans. Non-Medical costs include: adaptations to houses – including fitting of handrails and extensions, wheelchairs and car adaptations.

The medical costs, paid for by the NHS or social care were £3,244 per person per year and the costs increase as the disease became more severe. For the non-medical costs 75% came of out peoples own pocket (£939 per person per year), these costs dramatically increase with increasing disease severity.

These adaptations enabled people with disabilities either to stay at home or get out of hospital more quickly, safely and efficiently, indirectly reducing costs to the NHS.

The MS Register is open to new participants, if you have MS and live in the UK, sign up today and help make sense of MS!

 

Return to the MS Register Hub

Belfast Patient Experience Questionnaire

Dr Gavin V McDonnell, Belfast Health and Social Care Trust

MS is a complex and challenging condition for many if not all patients. A range of healthcare professionals can play key roles in treatment and management. We are interested in establishing across the UK just who patients see when attending outpatient clinics and whether they feel that others should be involved to meet their needs best.

Over the past 20 years, there have been significant and welcome developments in disease modifying therapies (DMTs). Increasing choice can however lead to complexity for patients in particular and their clinicians. We are interested in understanding how patients perceive the decision making process around treatments and how involved and informed they feel.

MRI (Magnetic Resonance Imaging of the brain with or without spinal cord) has had an important role in the diagnosis of MS for over 25 years and increasingly it is now used to assess disease stability and the safety and effectiveness of treatments. We are keen to establish how interested patients are in seeing their own MRI scans at clinic appointments and what their current level of access is.

Finally, we want to understand the patient perception of lumbar punctures (LPs/spinal taps). This can be an uncomfortable procedure for patients but does play an important supportive role in the diagnostic process. However it is also being suggested that lumbar punctures and analysis of the spinal fluid (also known as CSF) obtained could be of value beyond diagnosis, providing prognostic (predictive) information, assessing treatment effectiveness and guiding future treatment choices. Given the nature of the procedure we are keen to establish whether it would be of practical utility by testing its acceptability to patients.

Our goal is to obtain information across the UK that could improve service developments for patients with MS, improve the patient experience and guide future research and treatment approaches. Specifically we would like to test your experience of outpatient clinics, access to MRI scans, the information and decision making around disease modifying therapies (DMTs) and your attitude to the potential use of lumbar punctures (LPs/spinal taps) to improve our understanding of the processes underlying MS and potentially assess the effectiveness of treatments.

By Dr Gavin V McDonnell, Belfast Health and Social Care Trust

 

Return to UK MS Register Hub

A trial-ready community

The Stop-MS appeal by the MS Society aims to be in the final stages of testing treatments (to slow down or stop disability progression) for everyone with MS by 2025. They plan to raise £100 million and part of this funding will go towards the development of an “MS Trials Platform”.

The ambition of the MS Trials Platform is to develop treatments up to three times faster than is currently done now. It will provide a structure to test new and re-purposed drugs (those that are already used in other conditions) more quickly and cheaply. It also aims to have a community of people ready who are interested in MS Trials by having them pre-register so they can be contacted if they are eligible.

Another aim of the MS Trials Platform is to ensure that it is accessible to as many people with MS as possible.

The MS Register will be asking their participant’s to answer a questionnaire on their views on the idea of the MS Trials platform, what might make people decide to register and if they did, how they might like to be communicated with regarding potential trials.

 

Return to the UK MS Register Hub

Flexibility of thoughts

We know MS can cause spasticity in your body, maybe this can happen with thought processes too.

Our colleagues in the Institute of Mental Health in the University of Nottingham are looking into whether there could be justification for trialing a therapy for people with SPMS which aims to target ‘thinking inflexibility’ which can lead to becoming caught up in negative thoughts.

What do we mean by flexible thinking?

Flexible thinking is the ability to focus and engage fully in what we are doing, rather than being pushed around by our thoughts and feelings, and to make more effective choices based on the things that really matter to us

How flexible is your thinking?

The purpose of this project is to understand the relationship between anxiety, low mood and thinking flexibility in those with SPMS.

Those who are particularly inflexible may become “caught up” in negative thoughts, and feel these need to be controlled which restricts their ability to choose how to behave. However, those with greater thinking flexibility may be able to continue to live fulfilling and productive lives whilst allowing themselves to experience the full spectrum of pleasurable and distressing thoughts and sensations.

Return to the MS Register Hub

How MS affects mood

Patient update: How multiple sclerosis affects mood

I am Professor Dawn Langdon and with Dr Gurpreet Reen, have received a grant from the MS Society to use data from the UK MS Register to investigate mood in multiple sclerosis. We are both psychologists working at Royal Holloway University of London. As you know, people with MS are more likely to experience anxiety and depression than the general population and this affects their lives in a negative way, including employment and how well they manage their disease.

The UK MS Register is a very special set of data because it is collected from people with MS, recording their own experiences. It is also a very large set of data. In order to understand the impact of MS on mood using the UK MS Register data, we needed to identify complete data on mood and other related aspects of people’s lives. These were age, education, employment, disease subtype, physical impact, and psychological impact.

8,812 people with MS (of which 6,397 were female) had entered complete data on all these things. 5,541 had relapsing remitting MS, 2,085 had secondary progressive MS and 1,386 had primary progressive MS. About half of the people with MS reported raised levels of anxiety and also about half reported raised levels of depression. This is similar to other smaller studies which have previously been published.

We were able to use multiple regression, a statistical procedure which evaluates how different variables affect a particular variable of interest. We looked to see which variables were associated with anxiety and depression in MS. We are working on a scientific paper which we will submit to a peer review journal and will provide a more detailed update in due course.

Return to the MS Register Hub

How sedentary is your lifestyle?

In recent years there has been a growing amount of research into sedentary sedentarybehaviour  (large amounts of sitting and little physical exercise). The research is showing that there a many health risks associated with prolonged and excessive inactivity.

The University of Birmingham is working to find out more about the types of activities people with MS do and how these activities are associated with their MS experience.

There is some evidence that interventions to encourage people with MS to move more or sit less can have benefits, but we also know that this can be very difficult to do.  At the moment, we do not know what the most appropriate activities are to advise people with MS to do to achieve these benefits.  Finding out more about the types of activities people with MS do and how these activities are associated with MS experience will help us to develop interventions specifically aimed at people with MS.

The questionnaire will ask you about the activities you do while sitting down and while moving around.  We are asking you about a range of different activities, such as watching tv, household chores, walking, and exercise.  We are interested to hear how often you do these activities.  It can take up to 25 minutes to complete the questionnaires.  With these questionnaires, we are exploring the types of activities people with MS do during a regular day or week.  We are also examining how these activities are related to the way you experience your MS.

We will of course feed back the results to you once they have been analysed!

 

Return to the MS register Hub

Update on Vitamin D questionnaire

 

SunshineLast year we hosted a questionnaire in collaboration with Queen Mary University of London. The study looked  at vitamin D levels in the UK MS population. Vitamin D is one of the top research priorities for people living with MS and results from this study will provide information about the vitamin D status amongst the population.

The last vitamin D sampling kits were sent out just before Christmas. Whether your contribution was through completing the study questionnaire or taking part in the remote sampling part of the study, we really appreciate your help.

We are happy to say that almost two-thirds of the participants who were sent a sampling kit have now returned them to us. For anyone who has received a sampling kit from us earlier this year and not got around to doing your samples, remember – it is not too late! The more samples we get back the better and we will be continuing to collect samples over the next couple months.

Thanks again for your part in this important MS research – we look forward to sharing the results of this study with you in a few months!

Participant Feedback on the MS Register: 1 Year Since Website Relaunch

  1. How long have you been a participant on the MS Register?

Approximately 8 years

  1. How was it you came to be involved with the MS Register?

Advert via Facebook – I think – sorry long time ago now

  1. Why do you feel it’s valuable to contribute data to the MS Register?

I am 100% honest about how my MS affects me.  I don’t feel I am put on the spot or being judged.  If it helps any research – then that can only be a good thing. No needles, poking or prodding in this research,  so happy to answer and be part of this register

  1. Do you find the portal to be a useful, personal tool for your MS?

It is easy to use and it is good to look back at previous answers to see how, if and when things have changed.

  1. Do you have any other positive experiences of the Register that you’d like to share?

It is good to feel as if you may somehow help researchers understand what living with MS is like.

MF, Hampshire

 

  1. How long have you been a participant on the MS Register?

I do not know, I believe ever since the Register started I think

  1. How was it you came to be involved with the MS Register?

I have always followed the MS Society and when the register commenced or as soon as I was invited I accepted that opportunity

  1. Why do you feel it’s valuable to contribute data to the MS Register?

I believe that if I can add or offer anything to aide the research with regard to MS and its cure or symptom relief I would like to do that and always believe in giving something back

  1. Do you find the portal to be a useful, personal tool for your MS?

I find the portal interesting more than useful personally

  1. Do you have any other positive experiences of the Register that you’d like to share?

I have nothing particular to offer. I do believe the questionnaires need to be reviewed more diligently and cross referenced to the various different entities that are looking for the appropriate information and feedback as it does become somewhat repetitive and unnecessary answering the same question in principle a number of times when completing the questionnaires each time.

M. Pearce, Suffolk

 

  1. How long have you been a participant on the MS Register?

I can’t exactly remember how long I’ve been on the MS Register but I guess it’s about 7 years or so.

  1. How was it you came to be involved with the MS Register?

I received an email from the MS Register asking if I would participate. It seemed like a good idea and I’ve been participating ever since.

  1. Why do you feel it’s valuable to contribute data to the MS Register?

Anything that helps research into MS that may eventually make life easier for MS sufferers or even find a cure has to be a good thing. It’s no good burying your head in the sand and let others do it.

  1. Do you find the portal to be a useful, personal tool for your MS?

In a way. I appreciate researchers are looking for one’s experience within a snapshot of time but I feel like I want to say more. I find it a bit frustrating that I can’t expand on the answers. Having said that, having been involved in conducting surveys myself, I realise researchers don’t want people ‘rabbiting’ on. Not only do I have great difficulty walking, I can no longer drive due to MS. After 50 years of driving I find this has taken away yet more of my independence. Maybe the surveys aren’t interested if one can get around outside but it’s all part of living with MS.

  1. Do you have any other positive experiences of the Register that you’d like to share?

Some of the surveys provide results in the form of a graph. I find these particularly useful to compare my well-being from a few months, or years ago.

B. Eaton, Hampshire

The Latest Window of Questionnaires is Now Open!

It’s that time again – the next window for completing questionnaires is open. As you know we ask our regular surveys every six months. Please continue to complete these as they are important for all our research.

We also have the following guest questionnaire available for you to complete:

  • Wellbeing & MS (with Exeter University). Comprising 4 separate surveys, there are 57 questions in total and it may take up to 40 mins to complete. This research explores the link between value-for-money treatments and wellbeing in people with MS.
  • We need your EDSS. When completing surveys please remember to update your EDSS. Your EDSS score is very important to MS researchers, particularly for selecting study participants and determining those eligible for DMTs (Disease Modifying Therapies). This can be found on the bottom left of the survey list. You can also find it by clicking here.

And don’t forget, we always love hearing from you. It’s now been a whole year since we launched the new-look portal. Please tell us what you think of it… contact@ukmsregister.org

All questionnaires are available here… https://www.ukmsregister.org/

£1 Million Boost For Research Into Living With Multiple Sclerosis

The UK Multiple Sclerosis (MS) Register, based at Swansea University, has been awarded just over £1m investment from UK charity, the MS Society.

The Register is a ground-breaking medical research study that seeks to collect information from people with the disease about what it’s like to live day-to-day with Multiple Sclerosis. Established in 2011, it was the first UK-wide register of its kind for MS. It’s estimated that over 100,000 people live with the disease in the UK.

MS is one of the most common non-traumatic causes of disability in young adults worldwide. MS is a disease of the central nervous system that has a huge impact on the life of people affected by the disease. People with MS may suffer from physical disabilities, visual disturbances, fatigue, depression or cognitive dysfunction. All of which can influence activities of daily living, work ability, social participation and overall quality of life.

 

Through gathering large amounts of information from people with MS the Register is able to provide extremely rich, anonymised data for the purposes of medical research, which, it is hoped, can unlock some of the mysteries behind the disease. The Register collects data from three different sources;

  1. Self-reported outcomes from people with MS via website surveys.
  2. Clinical records from 47 NHS partner sites.
  3. Other routinely collected data from health and wellbeing services (e.g. General Practice).

The MS Society has remained the principal funder since its inception in 2011. Recognising the contribution of the Register to MS Research, Susan Kohlhaas, Director of Research at the MS Society said “we continue to be incredibly excited about the potential the Register holds in transforming our understanding of MS. Data science is an area that we as a country need to build capacity in… big data will revolutionise our understanding and treatment of diseases.”

The MS Register is part of the wider Population Data Science theme at Swansea University’s School of Medicine. It is a multidisciplinary theme of international standing, conducting Population Health Studies including clinical trials. The Register benefits greatly from this location owing to the world class expertise and collaborative research culture. This has evolved from pioneering work at Swansea in the 1990’s on linking health data sets and defining rigorous standards for medical records.

With this investment from the MS Society the Register hopes to further develop its platform, enhancing its usability and increasing the amount and type of data it collects. The Register continues to build on last year’s website re-launch, to improve its online interface with users and provide feedback to participants.

The Register is now looking to develop a similar interface for clinicians at its 47 partner NHS site locations. This will allow specialists in MS to see how the condition is affecting the day-to-day lives of patients away from the clinic, becoming an important tool for discussion around treatment options and lifestyle.

Other technical advancements are also in the pipeline in terms of the Register’s ability to capture more complex data types like MRI scan data. A ‘Machine Learning’ tool is also planned to extract and organise information directly from clinician’s letters to ease any administration burden for NHS staff.

People with multiple sclerosis (or people acting on behalf of a person with MS) can sign up to the UK MS Register by visiting www.ukmsregister.org .

Thank you for completing My MS My Needs 3.

The UK MS Register would like to share with you a message from Caroline Howlett of the MS Society’s Research Network…

‘You have spoken! Over 8,000 of you completed this year’s My MS My Needs survey. As a Person with MS and lay member of the Research Network working with the survey team, I’d like to extend a big ‘Thank You’ to you all.

Following on from your hard work, the team are now at the steep cliff face of analysing what this dataset tells us; one that’s large enough to find statistically, meaningful differences between bigger groupings such as regions of the country, but to also look into the findings in smaller, but key equality groupings of ethnic minorities and sexual orientation.

As a result, the MS Society will be able to track changes with the previous two studies’ results, likewise to see what issues remain of primary concern to us. Your time spent completing the detailed questionnaire will help make a real difference: Future Society policies will be shaped, as will campaign priorities.’

As the impact of these findings is realised, we at the UK MS Register will keep you updated. Thank you for your participation!

 

Imperial College London Drug Trial at Hammersmith Hospital

Division of Brain Sciences, Department of Medicine, Hammersmith Hospital Campus

Burlington Danes Building, Du Cane Road, London W12 0NN. Telephone number: 0207 7594 2855

Version 10, dated 14/06/2019

IRAS 218514

REC 17/LO/0566

An experimental medicine study to validate the 18 kD translocator protein (TSPO) as a novel neuroimmunomodulatory target in multiple sclerosis

Participant Information Sheet

Who is organising this study?

The Chief Investigator is Paul Matthews, Professor of Clinical Neuroscience and Head of the Division of Brain Sciences, Imperial College London. The Sponsor of the study is Imperial College London. The study is funded by the Medical Research Council (MRC).

What is the purpose of the study?

XBD173 is a drug which temporarily changes the activity of a protein called the 18 kD Translocator Protein (better known as TSPO) in the brain. TSPO could have a role in dampening inflammation in the brain. We would like to know whether XBD173 could be a potential treatment for patients with secondary progressive multiple sclerosis (SPMS).

Why have I been invited?

You have been invited because you have been diagnosed with SPMS or because you are a healthy volunteer.

Do I have to take part?

No, it is your choice. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. You will have as much time as you like to decide if you want to participate in the study. You are free to withdraw at any time, without giving a reason and your medical care will not be affected by that decision.

What will happen to me if I take part?

Screening (approximately 1 hour)

This will take place at the Clinical Research Facility (CRF) at the Hammersmith Hospital. If you agree to take part in the study, we will ask you some questions about your health, medical history, carry out a physical examination, vital signs, height and weight and review your notes to ensure that it is safe to enroll you. If so, we will take approximately 55 ml blood from you (around 4 tablespoons ). We will test your blood to learn what kind of TSPO gene you carry, as this affects how you might respond to these drugs. We also will perform “routine” blood tests before inviting you to take part in the study, including blood count, kidney and liver tests. When we have the results of the blood tests, we will then telephone you to let you know whether we are able to include you in the study. If your blood results show an abnormality, we may not be able to include you. However, we might invite you to come back at a later date to repeat the blood test. If it has returned to normal when we repeat it, we may then be able to include you in the study.

First study visit

Approximately 4 weeks later, we will invite you back to the CRF at the Hammersmith Hospital. We will ask you some questions about your health and perform a physical examination which will include listening to your heart and feeling your tummy. For women of childbearing age, we will also perform a urine pregnancy test. We will take another blood test of approximately 200 ml (approximately 4/5 of a cup).

After these tests, you will be given the first tablet of XBD173 to take whilst you are at the CRF, and will be monitored for at least 4 hours before you leave the CRF.  During the following week you will take a further 6 tablets of XBD173.

Monitoring telephone calls

If you are a healthy volunteer and experience any adverse reaction to the drug during the study, or have any medical concerns, you can contact the Principle Investigator Dr David Owen on 07801 140 800. If you are a SPMS patient, you can call the official mobile telephone number attached to the Multiple Sclerosis clinical trials team on 07779 106 743.

Second study visit  

6 days after the first visit, you will take your final dose of the study drug and we will invite you back to the CRF at the Hammersmith Hospital. We will repeat the procedures of the first study visit: we will ask you some questions about your health and perform a physical examination, perform a urine pregnancy test on women of childbearing age, and take another blood sample of approximately 200 ml (approximately 4/5 of a cup).

Reimbursement

You will be reimbursed £300 for participation in the study, as well as for reasonable travel expenses. If you do not complete the study you will be reimbursed according to how much of the study you completed.

What are the possible benefits of taking part?

The study will not benefit you.

What are the possible disadvantages and risks of taking part?

XBD173

XBD173 is a drug which was initially developed by the pharmaceutical company Novartis to treat anxiety. Novartis stopped developing XBD173 because it did not appear to relieve anxiety well. However, during the time that Novartis were testing XBD173, it was used in several research centres in Europe and the United States and given to hundreds of patients with generalised anxiety disorder and to healthy volunteers for up to 6 weeks at a time. In this study you will take one dose every morning for a week.

When XBD173 has been given to healthy volunteers in earlier studies, the most common side effects were abdominal symptoms (such as diarrhoea) and nervous system disorders (such as headache). However, these side effects were not severe, and were just as common in volunteers in the same study who only received a placebo (dummy drug) instead of XBD173.

Venous Cannulation

Insertion of a cannula (a tiny, short plastic tube into a vein) may cause brief discomfort as the cannula penetrates the skin, similar to the discomfort you have when having an injection.  We will use the cannula to take blood samples during the study visit. Risks of any cannulation include minor local bleeding and bruising.

Using contraception

If you agree to participate in the study, you must use appropriate contraception during and for 7 days (one week) after participation in the study if there is a risk that you or your partner may become pregnant. This applies to both male and female participants.

The appropriate methods of contraception are:

  • Complete abstinence
  • Injectable progestogen
  • Implants of levonorgestrel
  • Estrogenic vaginal ring
  • Percutaneous contraceptive patches
  • Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1% failure rate as stated in the product label
  • Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject’s entry into the study, and this male is the sole partner for that subject. For this definition, “documented” refers to the outcome of the investigator’s/designee’s medical examination of the subject or review of the subject’s medical his
    tory for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records.
  • Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository)

These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label.

If you have any questions about this please ask the study nurse or doctor.

Abstinence from alcohol

You will be required to abstain from alcohol for the during of dosing. This means that you are not allowed to drink alcohol for the 7 days during which you are taking XBD173.

What if something goes wrong?

Imperial College London holds insurance policies which apply to this study.  If you experience harm or injury as a result of taking part in this study, you will be eligible to claim compensation without having to prove that Imperial College is at fault.  This does not affect your legal rights to seek compensation. If you are harmed due to someone’s negligence, then you may have grounds for a legal action.  Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should  contact the Chief Investigator of the study, Paul Matthews (020 7594 2855, p.matthews@imperial.ac.uk), or the study co-investigator, David Owen (020 7594 7050, d.owen@imperial.ac.uk). You can also contact the 24-hour emergency number (07779 106 743), which is an official mobile telephone number attached to the Multiple Sclerosis clinical trials team. You can also contact the Patient Advice and Liaison Service (PALS) (020 3313 0088). The normal National Health Service complaint mechanisms are also available to you.  If you are still not satisfied with the response, you may contact the Imperial Academic Health Science Centre AHSC Joint Research Compliance Office (020 7594 1872).

What will happen if I don’t want to carry on with the study?

This research is voluntary and you are free to withdraw at any time, without giving a reason. Any stored blood or cells that can still be identified as yours will be destroyed if you wish.

If for any reason you are no longer able to consent due to ill-health we will withdraw you from the study. We will keep the data and stored blood and cells you donated and use them in the study. We will make sure you understand this when we take consent before the study begins.

What will happen if there is anything wrong with my results?

If the tests we do reveal unexpected abnormalities, we will discuss them with you and, if you allow us, we will notify your GP.

Will my taking part in this study be kept confidential?

All information that is collected about you during the course of the study will be kept confidential to the extent permitted by law. If you join the study, some parts of the data about you that is collected for the study will be looked at by authorised persons at Imperial College London.  They may also be looked at by representatives of regulatory authorities and by authorised people from the Trust and other designated academic researchers. The reason for this is to check that the study is being carried out correctly. Everyone involved directly in the study has a duty of confidentiality to you as a research participant and will take efforts to ensure that nothing that could reveal your identity will be disclosed outside the research site.

What will happen to my samples?

The study information will be anonymised before they are accessed for use in research.

Anonymised means these researchers will not be able to identify you as your personal details will have been removed from the sample and information we send them. To ensure the greatest benefit from your contributions, we also may share the anonymised data with other researchers.

Your blood samples will be analysed in a facility designated by the study team. The tests performed will include looking at genes and how they are expressed in your blood cells. No one will use the genetic data to try to diagnose another disease or to identify you.

Some samples also will be sent to the Hospital laboratory to perform routine tests. Unused samples will be frozen and stored and may be used for future research, which may include sending the samples to collaborators or others who may perform analyses. Any samples sent in this way will also be anonymised.

What will happen to the results of the research study?

The results of this study will be published in a medical journal. We intend to share results from the study with you and others who are participating, but you will not be identified by name in any report or publication.

Who is organising and funding the research?

The project is organised by the Chief Investigator, Paul Matthews, who is an employee of Imperial College London. No member of the research team is being paid based on the recruitment of people for the study. The study is being funded by the Medical Research Council.

Who has reviewed the study?

This research study has been reviewed by an ethics committee – a committee of people separate from your doctor, whose primary concerns are the safety, rights and welfare of patients on this study. The West London GTAC Research Ethics Committee has reviewed and approved all written materials about this study including this information sheet.

Contact for Further Information

Please ask any questions now that you wish to. A copy of this information and of the consent forms will be given to you to keep. If any questions occur to you later, or you have other concerns or would like to discuss any aspect of the study, please contact the following persons:

Dr. David Owen (Senior Lecturer and Honorary Consultant, 07801140800) or Prof. Paul Matthews (Chief Investigator, 0207 594 2855), 5th Floor Burlington Danes, Building Hammersmith Hospital, Du Cane Road, London W12 0NN

The MS Society Declares Future Funding for the Register

We are delighted to announce that the MS Society have agreed to continue their support for the UK MS Register. The current arrangement, due to expire in July 2019, has been renewed for a further 3 years which will see the Register through its 10th anniversary year in 2021 and on to 2022.

Based at Swansea University, the project has been run in partnership with the MS Society since our beginnings. This collaboration has been instrumental to our success; from our creation to a world leading medical registry at the forefront of MS research.

Recognising the contribution of the Register to MS Research, Susan Kohlhaas, Director of Research at the Society has written an article for the Association of Medical Research Charities (AMRC). Therein she comments “we continue to be incredibly excited about the potential the Register holds in transforming our understanding of MS …data science is an area that we as a country need to build capacity in… Big data will revolutionise our understanding and treatment of diseases.” You can read the full article on the AMRC website here.

The Register began as a pilot study in 2011; the first medical registry to link clinical data to self-reported outcomes, and has since grown to be one of the leading medical registries of its kind. We now have 5 members of permanent, dedicated staff, with additional support from Swansea University’s Data Science department. We have over 17,000 online participants and partner with 46 NHS sites who help us facilitate the clinical data linkage.

If you are new to either the clinical or the online part of the Register, or if even you’ve been with us a while, here’s an informative video we produced a little while ago that explains what we’re all about.

Click here to view the video

Over the course of the next 3 years our ambition is to grow the Register; more participants = more data = more research into MS. We also want the Register to be useful to everyone including the clinicians that we partner with. Our goal is to launch a clinical portal, alongside the existing participant portal, so that your MS Team can see what life with MS is like for you outside the clinic which will assist you with your appointments.

Read more