Neuropsychological evaluation and rehabilitation in multiple sclerosis
Neuropsychological Evaluation and Rehabilitation in Multiple Sclerosis (NEuRoMS): A mixed methods pragmatic multicentre Randomised Controlled Trial (RCT) with nested health economic and process evaluations and an implementation study (Phase 3: Work Packages 4 and 5)
What it found
No result yet.
What it measured
Main measures
Self-reported psychological impact of MS on everyday life at 3 months post-randomisation, the Psychological Subscale of the Multiple Sclerosis Impact Scale (MSIS-Psych version 1)
3, 6 and 12 months post randomisation
Quality of life (reported by participants)Previous primary outcome as of 14/10/2026: Self-reported psychological impact of MS on everyday life, measured using the Psychological Subscale of the Multiple Sclerosis Impact Scale (MSIS-Psych; Hobart et al., 2001) at baseline, 3, 6 and 12 months post randomisation. The primary endpoint is at 3 months post-randomisation.
Quality of life (reported by participants)
Other measures (1)
Current key secondary outcomes as of 14/10/2026: Outcomes for secondary objectives 1.1. and 1.2.: 1.1. Participant scores from cognitive screening measures (completed at a single time-point at screening) including an online, self-administered: Symbol Substitution Task (SST), and Word Colour Task (WCT). 1.2. Demographic, clinical features and screening usage information will be collected as part of
VisionThinking and memoryFatigueMood and sleepQuality of life (reported by participants)Feasibility
Who could take part
MS (type not specified) · 18 to 120
Show the full criteria
Inclusion criteria
Inclusion: Current key inclusion criteria as of 14/10/2026: All individuals: Able and willing to give consent and able to communicate in English. Participant information sheets can be provided in Welsh upon request but the standardised materials and tests to be used require communication in English since these have not yet been developed for other languages. Part 1: People with MS: 1.1. Diagnosis of MS 1.2. Aged 18 years or above, with no upper age limit Part 2: People with MS: 2.1. Aged 18 years or above, with no upper age limit 2.2. Diagnosis of MS 2.3. Received cognitive screening, and mild or moderate cognitive problems identified (Part 1): Mild or moderate problems will be identified by the clinical team based on the screening scores, the clinical and contextual information collected as part of the cognitive screening, and the patient-clinician conversations on cognitive problems experienced. Thresholds for mild and moderate cognitive problems in people with MS will be defined based on norms (WP6: compared to control participants (people without MS)) and based on previous research (van Dongen et al. 2020) and recommendations on classifications and labelling of neuropsychological assessments (Lezak 1996; Guilmette et al. 2020)*: -Mild cognitive problems: Scores of 1 SD below the mean or lower, and higher than 2 SD below the mean; -Moderate cognitive problems: Scores of 2 SD below the mean or lower, and higher than 2.5 SD below the mean. *People with scores in mild or moderate ranges in either cognitive test (SST and/or WCT) would be considered eligible to participate. Part 3: 3.1. People with MS: People with MS who participated in Part 2. 3.2. Intervention providers: AP/Research Nurses/Assistant OT delivering the NEuRoMS pathway and intervention to people with MS in Part 1 and Part 2. 3.3. Healthcare professionals (HCPs): 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: 4.1. People with MS: People with MS who participated in Part 2 4.2. Intervention providers: AP/Research Nurses/Assistant OT delivering the NEuRoMS pathway and intervention to people with MS in Part 1 and Part 2 4.3. HCPs: 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 4.4. Service commissioners: Service commissioners (or similar) working within the Clinical Commissioning Groups or Integrated Care Systems that commission new NHS services. Previous participant inclusion criteria: All individuals: Able and willing to give consent and able to communicate in English. Participant information sheets can be provided in Welsh upon request but the standardised materials and tests to be used require communication in English since these have not yet been developed for other languages. Part 1: People with MS: 1.1. Diagnosis of MS 1.2. Aged 18 years or above Part 2: People with MS: 2.1. Aged 18 years or above 2.2. Diagnosis of MS 2.3. Received cognitive screening, and mild or moderate cognitive problems identified (Part 1): Mild or moderate problems will be identified by the clinical team based on the screening scores, the clinical and contextual information collected as part of the cognitive screening, and the patient-clinician conversations on cognitive problems experienced. Thresholds for mild and moderate cognitive problems in people with MS will be defined based on norms (WP6: compared to control participants (people without MS)) defined by Lezak (1996) on the level of performance on SST and/or WCT*: -Mild cognitive problems: Scores of 1 SD below the mean or lower, and higher than 2 SD below the mean; -Moderate cognitive problems: Scores of 2 SD below the mean or lower, and higher than 2.5 SD below the mean. *People with scores in mild or moderate ranges in either cognitive test (SST and/or WCT) would be considered eligible to participate. Part 3: 3.1. People with MS: People with MS who participated in Part 2. 3.2. Intervention providers: AP/Research Nurses/Assistant OT delivering the NEuRoMS pathway and intervention to people with MS in Part 1 and Part 2. 3.3. Healthcare professionals (HCPs): 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: 4.1. People with MS: People with MS who participated in Part 2 4.2. Intervention providers: AP/Research Nurses/Assistant OT delivering the NEuRoMS pathway and intervention to people with MS in Part 1 and Part 2 4.3. HCPs: 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 4.4. Service commissioners: Service commissioners (or similar) working within the Clinical Commissioning Groups or Integrated Care Systems that commission new NHS services. Previous participant inclusion criteria as of 17/05/2024: All individuals: Able and willing to give consent and able to communicate in English. Participant information sheets can be provided in Welsh upon request but the standardised materials and tests to be used require communication in English since these have not yet been developed for other languages. Part 1: People with MS: 1.1. Diagnosis of MS 1.2. Aged 18 years or above Part 2: People with MS: 2.1. Aged 18 years or above 2.2. Diagnosis of MS 2.3. Received cognitive screening, and mild or moderate cognitive problems identified (Part 1): Mild or moderate problems will be identified by the clinical team based on the screening scores, the clinical and contextual information collected as part of the cognitive screening, and the patient-clinician conversations on cognitive problems experienced. Thresholds for mild and moderate cognitive problems in people with MS will be defined based on norms (WP6: compared to control participants (people without MS)) and based on previous research (van Dongen et al. 2020) and recommendations on classifications and labelling of neuropsychological assessments (Lezak 1996; Guilmette et al. 2020)*: -Mild cognitive problems: Scores of 1 SD below the mean or lower, and higher than 2 SD below the mean; -Moderate cognitive problems: Scores of 2 SD below the mean or lower, and higher than 2.5 SD below the mean. *People with scores in mild or moderate ranges in either cognitive test (SST and/or WCT) would be considered eligible to participate. Part 3: 3.1. People with MS: People with MS who participated in Part 2. 3.2. Intervention providers: AP/Research Nurses/Assistant OT delivering the NEuRoMS pathway and intervention to people with MS in Part 1 and Part 2. 3.3. Healthcare professionals (HCPs): 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: 4.1. People with MS: People with MS who participated in Part 2 4.2. Intervention providers: AP/Research Nurses/Assistant OT delivering the NEuRoMS pathway and intervention to people with MS in Part 1 and Part 2 4.3. HCPs: 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 4.4. Service commissioners: Service commissioners (or similar) working within the Clinical Commissioning Groups or Integrated Care Systems that commission new NHS services. Previous participant inclusion criteria: All individuals: Able and willing to give consent and able to communicate in English. Participant information sheets can
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Background and study aims 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. Who can participate? 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. What does the study involve? 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/focus groups 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/focus groups 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. What are the possible benefits and risks of participating? 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/focus groups), 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/focus groups and any other aspect of participants’ involvement can stop at any time if they do not wish to continue. Where is the study run from? This is a multicentre study conducted across seven NHS sites in the UK with MS outpatient clinics. When is the study starting and how long is it expected to run for? July 2017 to July 2027 Who is funding the study? National Institute for Health and Care Research (NIHR) (UK) Who is the main contact? Prof Roshan das Nair (Chief Investigator), roshan.dasnair@nottingham.ac.uk Dr Gogem Topcu (Programme Manager), gogem.topcu@nottingham.ac.uk
Loading reviews and guidelines…
History
Started
Jun 2024
Finished
Jul 2027