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Who Benefits Most From Cognitive Rehabilitation for Multiple Sclerosis?

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ClinicalTrials.gov Identifier: NCT05509426
Recruitment Status : Recruiting
First Posted : August 22, 2022
Last Update Posted : September 9, 2022
Sponsor:
Collaborators:
MS Society
University of Lincoln
Information provided by (Responsible Party):
University of Nottingham

Brief 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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Cognitive Rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determining Who Benefits Most From Cognitive Rehabilitation for Attention and Memory in Multiple Sclerosis: A Randomised Controlled Feasibility Trial
Actual Study Start Date : August 15, 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
This group will receive an online cognitive rehabilitation programme, offered in addition to usual clinical care, to groups of 4-6 participants weekly for 10 sessions.
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.

No Intervention: Usual Clinical Care
This group will receive only their usual clinical care, which may include information on cognitive problems as per clinical practice but not specific cognitive rehabilitation.



Primary Outcome Measures :
  1. Acceptability and feasibility of conducting an online group-based cognitive rehabilitation programme. [ Time Frame: Between the 3-month follow-up point and the 6-month follow-up point, up to 3 months. ]
    Feedback interviews will be conducted to understand the acceptability and feasibility of the intervention.

  2. Appropriateness of eligibility criteria, baseline and outcome measures, recording of sessions, and randomisation protocol. [ Time Frame: From the date of randomisation to date of final follow-up, up to 1 year. ]
    Rates of enrolment and drop out will be recorded. Fidelity of the intervention will be assessed by video recording.

  3. Estimating sample size needed for Phase III RCT. [ Time Frame: From the start of the data analysis to study completion date, up to 6 months. ]
    Sample size calculations will be conducted during the primary analysis.

  4. Completion rates of outcome measures. [ Time Frame: 6 months. ]
    Based on how many participants complete all of the outcome measures.


Secondary Outcome Measures :
  1. Multiple Sclerosis Impact Scale-29 [ Time Frame: Baseline, 3-months post randomisation, 6-month post randomisation ]
    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.

  2. Everyday Memory Questionnaire-participant. [ Time Frame: Baseline, 3-months post randomisation, 6-month post randomisation. ]
    Cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 112. Higher scores indicate more frequent memory problems.

  3. Everyday Memory Questionnaire-relative. [ Time Frame: Baseline, 3-months post randomisation, 6-month post randomisation. ]
    Cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 112. Higher scores indicate more frequent memory problems.

  4. General Health Questionnaire-30. [ Time Frame: Baseline, 3-months post randomisation, 6-month post randomisation. ]
    Non-cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 90. Higher scores indicate increased psychological distress.

  5. Fatigue Severity Scale. [ Time Frame: Baseline, 3-months post randomisation, 6-month post randomisation. ]
    Non-cognitive questionnaire; Reliable Change Index between groups. Scores range from -3.4 to 3.4. Higher scores indicate a greater impact of fatigue.

  6. EuroQol-5 Dimensions, five-level version. [ Time Frame: Baseline, 3-months post randomisation, 6-month post randomisation. ]
    Non-cognitive questionnaire; Reliable Change Index between groups. Scores from 0 to 100. Higher scores indicate better overall health.

  7. Guy's Neurological Disability Scale. [ Time Frame: Baseline, 3-months post randomisation, 6-month post randomisation. ]
    Non-cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 55. Higher scores indicate increased disability.

  8. Brief Repeatable Battery of Neuropsychological Tests. [ Time Frame: Baseline, 3-months post randomisation, 6-month post randomisation. ]
    Cognitive test; Reliable Change Index between groups. Scores ranges vary depending on the individual test. Higher scores indicate better performance.

  9. Doors and People test. [ Time Frame: Baseline, 3-months post randomisation, 6-month post randomisation. ]
    Cognitive test; Reliable Change Index between groups. Scores range from 0 to 20. Higher scores indicate better performance.

  10. Trail Making Test. [ Time Frame: Baseline, 3-months post randomisation, 6-month post randomisation. ]
    Cognitive test; Reliable Change Index between groups. Scores range from 0 to 20. Higher scores indicate better performance.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05509426


Contacts
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Contact: Roshan das Nair, PhD +44(0)115 8230589 roshan.dasnair@nottigham.ac.uk
Contact: Lauren A Taylor, BSc, MRes lauren.taylor@nottingham.ac.uk

Locations
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United Kingdom
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom
Contact: Nikos Evangelou, MD         
Sponsors and Collaborators
University of Nottingham
MS Society
University of Lincoln
Investigators
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Principal Investigator: Roshan das Nair, PhD University of Nottingham
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT05509426    
Other Study ID Numbers: 21063
First Posted: August 22, 2022    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases