Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): protocol for a mixed-methods, multicentre feasibility randomised controlled trial

Gogem Topcu; Laura Smith; Jacqueline R Mhizha-Murira; Nia Goulden; Zoë Hoare; Avril Drummond; Deborah Fitzsimmons; Nikos Evangelou; Klaus Schmierer; Emma C Tallantyre; Paul Leighton; Kimberley Allen-Philbey; Andrea Stennett; Paul Bradley; Clare Bale; James Turton; Roshan das Nair; NEuRoMS Collective

doi:10.1186/s40814-022-01073-5

Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): protocol for a mixed-methods, multicentre feasibility randomised controlled trial

Pilot Feasibility Stud. 2022 Jun 11;8(1):123. doi: 10.1186/s40814-022-01073-5.

Authors

Gogem Topcu¹, Laura Smith², Jacqueline R Mhizha-Murira¹, Nia Goulden³, Zoë Hoare³, Avril Drummond⁴, Deborah Fitzsimmons⁵, Nikos Evangelou^{1

6}, Klaus Schmierer^{7

8}, Emma C Tallantyre^{9

10}, Paul Leighton¹¹, Kimberley Allen-Philbey^{7

8}, Andrea Stennett¹², Paul Bradley¹⁰, Clare Bale¹³, James Turton¹³, Roshan das Nair^{14

15}; NEuRoMS Collective

Affiliations

¹ Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK.
² School of Psychology, Keynes College, University of Kent, Canterbury, Kent, UK.
³ North Wales Organisation for Randomised Trials in Health Clinical Trials Unit, Bangor University, Bangor, UK.
⁴ School of Health Sciences, University of Nottingham, Nottingham, UK.
⁵ Swansea Centre for Health Economics, School of Health and Social Care, Faculty of Medicine, Health and Life Sciences, Swansea University, Swansea, UK.
⁶ Department of Neurology, Nottingham University Hospitals NHS Trust, Nottingham, UK.
⁷ Centre for Neuroscience, Surgery and Trauma, Barts and the London School of Medicine and Dentistry, The Blizard Institute, Queen Mary University of London, London, UK.
⁸ Clinical Board Medicine (Neuroscience), The Royal London Hospital, Barts Health NHS Trust, London, UK.
⁹ Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, UK.
¹⁰ Department of Neurology, Cardiff and Vale University Health Board, Cardiff, UK.
¹¹ Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK.
¹² Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
¹³ Multiple Sclerosis Patient and Public Involvement Group, Nottingham, UK.
¹⁴ Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK. roshan.dasnair@nottingham.ac.uk.
¹⁵ Institute of Mental Health, Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK. roshan.dasnair@nottingham.ac.uk.

Abstract

Background: Cognitive problems affect up to 70% of people with multiple sclerosis (MS), which can negatively impact mood, ability to work, and quality of life. Addressing cognitive problems is a top 10 research priority for people with MS. Our ongoing research has systematically developed a cognitive screening and management pathway (NEuRoMS) tailored for people with MS, involving a brief cognitive evaluation and rehabilitation intervention. The present study aims to assess the feasibility of delivering the pathway and will inform the design of a definitive randomised controlled trial (RCT) to investigate the clinical and cost-effectiveness of the intervention and eventually guide its clinical implementation.

Methods: The feasibility study is in three parts. Part 1 involves an observational study of those who receive screening and support for cognitive problems, using routinely collected clinical data. Part 2 is a two-arm, parallel group, multicentre, feasibility RCT with a nested fidelity evaluation. This part will evaluate the feasibility of undertaking a definitive trial comparing the NEuRoMS intervention plus usual care to usual care only, amongst people with MS with mild cognitive problems (n = 60). In part 3, semi-structured interviews will be undertaken with participants from part 2 (n = 25), clinicians (n = 9), and intervention providers (n = 3) involved in delivering the NEuRoMS cognitive screening and management pathway. MS participants will be recruited from outpatient clinics at three UK National Health Service hospitals.

Discussion: Timely screening and effective management of cognitive problems in MS are urgently needed due to the detrimental consequences of cognitive problems on people with MS, the healthcare system, and wider society. The NEuRoMS intervention is based on previous and extant literature and has been co-constructed with relevant stakeholders. If effective, the NEuRoMS pathway will facilitate timely identification and management of cognitive problems in people with MS.

Trial registration: ISRCTN11203922 . Prospectively registered on 09.02.2021.

Keywords: Cognition; Cognitive screening; Feasibility study; Multiple sclerosis; Randomised controlled trial; Rehabilitation.

Grants and funding

RP-PG-0218-20002/National Institute for Health Research