Cognitive Reserve-building Activities in Multiple Sclerosis
Denmark60 participantsStarted 2022-12-01
Plain-language summary
The study is a crossover randomized controlled trial investigating the effect of increasing engagement in cognitive leisure activities for individuals with multiple sclerosis.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* RRMS, SPMS or PPMS
* Age 18-65
* EDSS score ≤ 6.5
* SDMT (or PASAT) score below -1 SD
* No depression based on the MDI
* Able to use computer or smartphone and has internet access
* If in treatment with one or more of the following medications, the dosage must be stable:
* Cannabinoids
* Anticholinergic medications
* Sedatives e.g., benzodiazepines
* Opioids
* Antispasmodics
* Beta-blockers
* Antidepressant medication
* Fampridine
Exclusion Criteria:
* Planned start-up or discontinuation of one or more of the above-mentioned medications
* Structural brain changes following previous head trauma or neurological conditions other than which lead to structural changes or affect cognitive abilities
* Epilepsy
* Significant psychiatric co-morbidity
* Significant somatic co-morbidity including, but not limited to, severe cardiovascular disease as well as liver, kidney, and endocrine diseases
* Relapse 3 months prior to inclusion
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in score on the Symbol Digit Modality Test (SDMT)
Timeframe: Baseline, week 12, week 24
2
Change in score on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)