Who Benefits Most From Cognitive Rehabilitation for Multiple Sclerosis?

Multiple Sclerosis Clinical Trial

Official title:

Determining Who Benefits Most From Cognitive Rehabilitation for Attention and Memory in Multiple Sclerosis: A Randomised Controlled Feasibility Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05509426
• Other study ID #: 21063
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: November 2023

Study information

• Verified date: September 2022
• Source: University of Nottingham
• Contact: Roshan das Nair, PhD
• Phone: +44(0)115 8230589
• Email: roshan.dasnair[@]nottigham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Over the last 20 years, there have been many studies investigating the efficacy of attention and memory rehabilitation for people with multiple sclerosis (MS) however, there appears to be a lack of conclusive evidence regarding the true effectiveness of this intervention. This could be because the participant samples recruited to these studies are often extremely varied in terms of socio-demographics and clinical characteristics, and it would be very unlikely that all people with MS would benefit from these interventions uniformly. Therefore, there is a need to explore which subgroups of people with MS benefit most from cognitive rehabilitation so that this information can be used to help clinicians and services make decisions as to whom this intervention is offered. Cognitive rehabilitation is not routinely provided on the NHS due to lack of resources. This research is important as it will allow these resources to be optimised and made available to those who need them, but also to allow clinicians to understand whether their patient is likely to benefit from cognitive rehabilitation before it is offered. The primary aim of this study is to assess the feasibility and acceptability of undertaking a randomised controlled trial (RCT) to investigate the effectiveness of an online group-based cognitive rehabilitation programme with specific groups of people with MS. The secondary aim is to understand the impact that this intervention may have on various aspects of cognition such as memory, attention, and information processing. This will be assessed through various questionnaires and objective neuropsychological tests. In addition, an algorithm has been developed following the secondary data analysis of a large RCT investigating group-based cognitive rehabilitation for people with MS. This algorithm may be able to determine who benefits most from cognitive rehabilitation, we will therefore use this as part of the data analysis to understand if the algorithm has the potential to be an accurate clinical prediction tool. After completion of the cognitive rehabilitation, a small number of participants in the intervention group will be invited to take part in feedback interviews to give their views on the feasibility and acceptability of the group-based online cognitive rehabilitation and provide any suggestions for improvements for future trials.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: November 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18 or over and under 70 years of age.
• Have MS, diagnosed at least 3 months prior to recruitment.
• Have cognitive deficits, defined as performance below the 25th percentile on the Brief Repeatable Battery of Neuropsychological Tests (BRBN).
• Able to speak English sufficiently to complete the cognitive assessments and take part in group sessions.
• Have access to laptop or PC that supports MS Teams.
• Able to give informed consent.

Exclusion Criteria:

• Vision or hearing problems, such that they are unable to complete the cognitive assessments, judged assessor.
• Have concurrent severe medical or psychiatric conditions which would prevent participants from engaging in treatment, if allocated.
• Are involved in other psychological intervention trials.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Cognitive Rehabilitation
This cognitive rehabilitation will be tailored to each participant's cognitive status while maintaining a systematic treatment approach to attention and memory, following a study treatment manual. The intervention will include (i) restitution strategies to retain memory and attention functions including strategies to improve encoding and retrieval, (ii) compensation strategies, including internal mnemonics, use of external devices and ways of coping with attention and memory problems, (iii) the importance of errorless learning. The emphasis will be on identifying the most appropriate strategies to help individuals overcome their cognitive problems and in providing participants with a range of techniques, which they can adapt and use according to their needs. This is group based intervention that will take place remotely using MS Teams.

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham

Sponsors (3)

Lead Sponsor	Collaborator
University of Nottingham	MS Society, University of Lincoln

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability and feasibility of conducting an online group-based cognitive rehabilitation programme.	Feedback interviews will be conducted to understand the acceptability and feasibility of the intervention.	Between the 3-month follow-up point and the 6-month follow-up point, up to 3 months.
Primary	Appropriateness of eligibility criteria, baseline and outcome measures, recording of sessions, and randomisation protocol.	Rates of enrolment and drop out will be recorded. Fidelity of the intervention will be assessed by video recording.	From the date of randomisation to date of final follow-up, up to 1 year.
Primary	Estimating sample size needed for Phase III RCT.	Sample size calculations will be conducted during the primary analysis.	From the start of the data analysis to study completion date, up to 6 months.
Primary	Completion rates of outcome measures.	Based on how many participants complete all of the outcome measures.	6 months.
Secondary	Multiple Sclerosis Impact Scale-29	Non-cognitive questionnaire; Reliable Change Index between groups. Scores range from 9 to 36. Higher scores indicate greater psychological impact of MS on everyday life.	Baseline, 3-months post randomisation, 6-month post randomisation
Secondary	Everyday Memory Questionnaire-participant.	Cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 112. Higher scores indicate more frequent memory problems.	Baseline, 3-months post randomisation, 6-month post randomisation.
Secondary	Everyday Memory Questionnaire-relative.	Cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 112. Higher scores indicate more frequent memory problems.	Baseline, 3-months post randomisation, 6-month post randomisation.
Secondary	General Health Questionnaire-30.	Non-cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 90. Higher scores indicate increased psychological distress.	Baseline, 3-months post randomisation, 6-month post randomisation.
Secondary	Fatigue Severity Scale.	Non-cognitive questionnaire; Reliable Change Index between groups. Scores range from -3.4 to 3.4. Higher scores indicate a greater impact of fatigue.	Baseline, 3-months post randomisation, 6-month post randomisation.
Secondary	EuroQol-5 Dimensions, five-level version.	Non-cognitive questionnaire; Reliable Change Index between groups. Scores from 0 to 100. Higher scores indicate better overall health.	Baseline, 3-months post randomisation, 6-month post randomisation.
Secondary	Guy's Neurological Disability Scale.	Non-cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 55. Higher scores indicate increased disability.	Baseline, 3-months post randomisation, 6-month post randomisation.
Secondary	Brief Repeatable Battery of Neuropsychological Tests.	Cognitive test; Reliable Change Index between groups. Scores ranges vary depending on the individual test. Higher scores indicate better performance.	Baseline, 3-months post randomisation, 6-month post randomisation.
Secondary	Doors and People test.	Cognitive test; Reliable Change Index between groups. Scores range from 0 to 20. Higher scores indicate better performance.	Baseline, 3-months post randomisation, 6-month post randomisation.
Secondary	Trail Making Test.	Cognitive test; Reliable Change Index between groups. Scores range from 0 to 20. Higher scores indicate better performance.	Baseline, 3-months post randomisation, 6-month post randomisation.