Cognitive Reserve-building Activities in Multiple Sclerosis

NCT ID: NCT05691192

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2025-02-12

Brief Summary

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

Detailed Description

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

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Leisure Activities

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Andreas Kirknæs Færk

Neuropsychologist, PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Kirknæs Færk

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Glostrup Municipality, , Denmark

Countries

Denmark

Related Links

https://dmsc.dk/onewebmedia/CRAMS%20research%20protocol.pdf

Full study protocol with all references

Other Identifiers

H-20075846

Identifier Type: -

Identifier Source: org_study_id