Cognitive Reserve-building Activities in Multiple Sclerosis (CRAMS)

Rigshospitalet

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Behavioral: Cognitive Leisure Activities

Study type: Interventional

Funder types: Other

Identifiers

NCT05691192

H-20075846

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Cognitive Leisure Activities

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Leisure Activities

Passive control

No Intervention group

Description:

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.