Participate in a Clinical Trial
Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.
Who Benefits Most From Cognitive Rehabilitation for Multiple Sclerosis?
Study Purpose
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 Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years - 70 Years |
| Gender | All |
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05509426 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
University of Nottingham |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Roshan das Nair, PhD |
| Principal Investigator Affiliation | University of Nottingham |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Recruiting |
| Countries | United Kingdom |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Sclerosis |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
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