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Cognitive Reserve-building Activities in Multiple Sclerosis

Study Purpose

The study is a crossover randomized controlled trial investigating the effect of increasing engagement in cognitive leisure activities for individuals with multiple sclerosis.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
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 - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

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.	NCT05691192
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.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Rigshospitalet, Denmark
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Andreas Kirknæs Færk
Principal Investigator Affiliation	Danish Multiple Sclerosis Center, Copenhagen University Hospital, Rigshospitalet-Glostrup
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Denmark
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis
Study Website:	View Trial Website

Additional Details

The study is a crossover randomized controlled trial investigating the impact of cognitive leisure activities on the cognitive functioning of individuals with multiple sclerosis (MS). The goal is to investigate whether increasing leisure activities may help prevent cognitive impairment in individuals with MS. The trial consists of two studies. The first is a randomized controlled trial examining the effects of increasing engagement in cognitive leisure activities. The second is a qualitative interview-based study to identify factors that may improve adherence and acceptance of the intervention. The study employs a randomized, controlled crossover design, with 60 participants (30 with relapsing-remitting MS, 30 with progressive MS) assigned to either an intervention group or a passive control group for 12 weeks. After the initial 12 weeks the groups are crossed over and followed up after an additional 12 weeks. The intervention group will receive instruction and support to engage in cognitive leisure activities, while the control group will continue with their usual daily activities. For a detailed description of the project, the full protocol can be found at: https://dmsc.dk/onewebmedia/CRAMS%20research%20protocol.pdf

Arms & Interventions

Arms

Experimental: Cognitive Leisure Activities

Participants in the intervention group will engage in cognitive leisure activities for 12 weeks and will be instructed to track their daily activity level in minutes through a daily online questionnaire. To maintain motivation and improve adherence to the study protocol, participants will also receive regular follow-up phone calls from a member of the research team every 2 weeks. After the initial 12 weeks, the groups will be crossed over and the study will continue for another 12 weeks.

No Intervention: Passive control

Participants in the passive control group will not receive information regarding the intervention and cognitive leisure activities. They will instead be instructed to carry on as usual and to expect active participation in the study in 12 weeks from the time of enrolment.

Interventions

Behavioral: - Cognitive Leisure Activities

Participants in the active phase of the study will be asked to increase engagement in certain cognitive leisure activities. The activities are chosen on the basis of previous research and measures of cognitive reserve-building activities.

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.

International Sites

Glostrup, Denmark

Status

Recruiting

Address

Danish Multiple Sclerosis Center, Copenhagen University Hospital, Rigshospitalet-Glostrup

Glostrup, , 2600

Site Contact

Andreas Kirknæs Færk

[email protected]

+4538633205

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