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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Gogem Topcu
-
gogem.topcu@nottingham.ac.uk


Prof Roshan das Nair
-
Roshan.dasnair@nottingham.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Neuropsychological evaluation and rehabilitation in multiple sclerosis – definitive randomised controlled trial (RCT) and implementation study
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Neuropsychological evaluation and rehabilitation in multiple sclerosis – definitive randomised controlled trial (RCT) and implementation study

Recruiting

Open to: All Genders

Age: Adult

Nottingham London Lincoln Cardiff Sheffield Newcastle upon Tyne Leeds

Medical Conditions

Multiple Sclerosis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Problems with memory, attention, and problem solving (together known as ‘cognitive’ problems) affect up to 70% of people with multiple sclerosis (MS). These problems are distressing for people with MS, affecting their mood, ability to work, and enjoy social activities. Therefore, treating cognitive problems is a ‘top 10’ research priority for people with MS. The NEuRoMS (Neuropsychological Evaluation and Rehabilitation in Multiple Sclerosis) project aims to develop a clinical pathway, to routinely assess people with MS for cognitive problems using brief, online tasks (cognitive screening) and provide appropriate support to help them manage these problems. In this study, we will implement the pathway in seven study sites to evaluate the clinical and cost-effectiveness of the NEuRoMS rehabilitation intervention, and explore the process of implementation of the NEuRoMS screening and management pathway.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Jun 2024 30 Apr 2027

Using a mix of different methodological approaches, we will:
Part 1. Assess the frequency and severity of cognitive problems in people with MS using collected cognitive screening data.

Part 2: Recruit 478 people with MS with mild or moderate cognitive problems, who will either receive the NEuRoMS rehabilitation intervention plus usual care (intervention group) or receive usual care only (control group). The brief therapist-led, manualised intervention provides information and strategies to help people cope with their cognitive problems. We will evaluate the clinical and cost-effectiveness of the intervention to reduce the impact of cognitive problems amongst people with MS.

Part 3: Use observations, questionnaires, and interviews with Part 2 participants and healthcare professionals involved in delivering the pathway and the intervention to understand how the cognitive screening and management pathway and intervention work in practice (process evaluation).

Part 4: Conduct interviews with people with MS, healthcare professionals, intervention providers and service commissioners to understand the processes of implementation in ‘real world’ settings by exploring facilitators and barriers to implementation of the pathway and the intervention.


Part 1: People diagnosed with multiple sclerosis who are aged 18 and above.
Part 2: People diagnosed with multiple sclerosis who are aged 18 and above that received cognitive screening and were identified with mild or moderate cognitive problems.
Part 3: People with multiple sclerosis who participated in Part 2 of the study; Intervention providers delivering the NEuRoMS pathway and intervention to people with MS in Part 1 and 2; Healthcare professionals (e.g., neurologists, MS nurse specialists, psychologists, occupational therapists, physiotherapists) delivering the NEuRoMS screening and management pathway to people with MS in Part 1.
Part 4: People with multiple sclerosis who participated in Part 2 of the study; Intervention providers delivering the NEuRoMS pathway and intervention to people with MS in Part 1 and 2; Healthcare professionals (e.g., neurologists, MS nurse specialists, psychologists, occupational therapists, physiotherapists) delivering the NEuRoMS screening and management pathway to people with MS in Part 1; Service commissioners (or similar) working with the Clinical Commissioning Groups or Integrated Care Systems that commission new NHS services.

You can take part if:



You may not be able to take part if:


1. All participants: Do not have mental capacity to consent to participate in the study.

Part 2 participants only: 2.1. Currently receiving neuropsychological intervention for cognitive problems2.2. Received NEuRoMS intervention during WP2ii or WP3.

Part 3 patient participants only: 3.1. Participated in Part 4 interviews.

Part 4 patient participants only:4.1. Participated in Part 3 interviews.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus
    Nottingham University Hospital Derby Road
    Nottingham
    NG7 2UH
  • Barts Health NHS Trust
    The Royal London Hospital 80 Newark Street
    London
    E1 2ES
  • United Lincolnshire Hospitals NHS Trust
    Lincoln County Hospital Greetwell Road
    Lincoln
    LN2 5QY
  • Cardiff and Vale University Health Board
    University Hospital of Wales Heath Park
    Cardiff
    CF14 4XW
  • Sheffield Teaching Hospitals NHS Foundation Trust
    Royal Hallamshire Hospital Glossop Road
    Sheffield
    S10 2JF
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Royal Victoria Infirmary Queen Victoria Road
    Newcastle upon Tyne
    NE1 4LP
  • The Leeds Teaching Hospitals NHS Trust
    Leeds General Infirmary Great George St
    Leeds
    LS1 3EX

It is not known whether the study will have a direct benefit to participants, but participating means that they may help people with MS in the future. The information we get from this study will help us decide how to develop this screening and management pathway further in the hope of providing standardised screening and support for cognitive problems in MS.
When talking about experiences and issues associated with cognitive problems, participants may feel upset. This may also cause some concerns about their own cognitive abilities. If this happens during the cognitive management programme (including the feedback interviews), the clinician or researcher will be there to talk through these concerns. Participants will have their contact information in case they feel upset after the session for reasons associated with participation. The screening, cognitive management sessions, interviews and any other aspect of participants’ involvement can stop at any time if they do not wish to continue.

Dr Gogem Topcu
-
gogem.topcu@nottingham.ac.uk


Prof Roshan das Nair
-
Roshan.dasnair@nottingham.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Nottinghamshire Healthcare NHS Foundation Trust and funded by National Institute for Health and Care Research.




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Read full details for Trial ID: ISRCTN10285713

Or CPMS 58780

Last updated 17 May 2024

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