Multiple SclerosisNCT05509426
Who Benefits Most From Cognitive Rehabilitation for Multiple Sclerosis?
A study testing Cognitive Rehabilitation in people with Multiple Sclerosis, run by University of Nottingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Cognitive Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Aug 2022to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Lauren A Taylor, BSc, MRes contact
United Kingdom1 site, 1 recruiting
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham
Nikos Evangelou, MD
About this study
Official title: Determining Who Benefits Most From Cognitive Rehabilitation for Attention and Memory in Multiple Sclerosis: A Randomised Controlled Feasibility Trial
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.
Read more
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Cognitive Rehabilitation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Cognitive Rehabilitation |
| Usual Clinical Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between the 3-month follow-up point and the 6-month follow-up point, up to 3 months.
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.
Measured: From the date of randomisation to date of final follow-up, up to 1 year.
Estimating sample size needed for Phase III RCT.
Sample size calculations will be conducted during the primary analysis.
Measured: From the start of the data analysis to study completion date, up to 6 months.
Completion rates of outcome measures.
Based on how many participants complete all of the outcome measures.
Measured: 6 months.
Secondary outcomes (10)
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.
Measured: Baseline, 3-months post randomisation, 6-month post randomisation
Everyday Memory Questionnaire-participant.
Cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 112. Higher scores indicate more frequent memory problems.
Measured: Baseline, 3-months post randomisation, 6-month post randomisation.
Everyday Memory Questionnaire-relative.
Cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 112. Higher scores indicate more frequent memory problems.
Measured: Baseline, 3-months post randomisation, 6-month post randomisation.
General Health Questionnaire-30.
Non-cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 90. Higher scores indicate increased psychological distress.
Measured: Baseline, 3-months post randomisation, 6-month post randomisation.
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.
Measured: Baseline, 3-months post randomisation, 6-month post randomisation.
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.
Measured: Baseline, 3-months post randomisation, 6-month post randomisation.
Guy's Neurological Disability Scale.
Non-cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 55. Higher scores indicate increased disability.
Measured: Baseline, 3-months post randomisation, 6-month post randomisation.
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.
Measured: Baseline, 3-months post randomisation, 6-month post randomisation.
Doors and People test.
Cognitive test; Reliable Change Index between groups. Scores range from 0 to 20. Higher scores indicate better performance.
Measured: Baseline, 3-months post randomisation, 6-month post randomisation.
Trail Making Test.
Cognitive test; Reliable Change Index between groups. Scores range from 0 to 20. Higher scores indicate better performance.
Measured: Baseline, 3-months post randomisation, 6-month post randomisation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start15 Aug 2022
- Primary completionJul 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society, University of Lincoln
- Responsible party
- Sponsor
- Investigators
- Roshan das Nair, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509426
- Sponsor's protocol ID
- 21063
- Status last verified
- Sep 2022
- First submitted
- 31 May 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Who Benefits Most From Cognitive Rehabilitation for Attention and Memory in Multiple Sclerosis: A Randomised Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT05509426
- Acronym / sponsor ID
- 21063
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society, University of Lincoln
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Cognitive RehabilitationThis 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. |
| Usual Clinical Care | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive RehabilitationThis 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. | Behavioural | Intervention Group |
Primary outcome
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.
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.
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.
Completion rates of outcome measures.
Time frame: 6 months.
Based on how many participants complete all of the outcome measures.
10 secondary outcomes
Multiple Sclerosis Impact Scale-29
Time frame: Baseline, 3-months post randomisation, 6-month post randomisation
Everyday Memory Questionnaire-participant.
Time frame: Baseline, 3-months post randomisation, 6-month post randomisation.
Everyday Memory Questionnaire-relative.
Time frame: Baseline, 3-months post randomisation, 6-month post randomisation.
General Health Questionnaire-30.
Time frame: Baseline, 3-months post randomisation, 6-month post randomisation.
Fatigue Severity Scale.
Time frame: Baseline, 3-months post randomisation, 6-month post randomisation.
EuroQol-5 Dimensions, five-level version.
Time frame: Baseline, 3-months post randomisation, 6-month post randomisation.
Guy's Neurological Disability Scale.
Time frame: Baseline, 3-months post randomisation, 6-month post randomisation.
Brief Repeatable Battery of Neuropsychological Tests.
Time frame: Baseline, 3-months post randomisation, 6-month post randomisation.
Doors and People test.
Time frame: Baseline, 3-months post randomisation, 6-month post randomisation.
Trail Making Test.
Time frame: Baseline, 3-months post randomisation, 6-month post randomisation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren A Taylor, BSc, MRes contact
Roshan das Nair, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Rehabilitation in people with Multiple Sclerosis, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roshan das Nair, PhD (+44(0)115 8230589, roshan.dasnair@nottigham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.