Cognitive Reserve-building Activities in Multiple Sclerosis

Phase 2

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Cognitive Leisure Activities

• Registration Number: NCT05691192
• Lead Sponsor: Rigshospitalet, Denmark

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

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-19
• Primary Completion: 2024-11-27
• Status Verified: 2024-12
• Study Completion: 2025-02-12
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cognitive Leisure Activities	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.

Primary Outcome Measures

Name	Time	Method
Change in score on the Symbol Digit Modality Test (SDMT)	Baseline, week 12, week 24	An objective measure of cognitive efficiency
Change in score on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)	Baseline, week 12, week 24	A subjective measure of cognitive symptoms for patients with MS

Secondary Outcome Measures

Name	Time	Method
Change in score on the California Verbal Learning Test II (CVLT II)	Baseline, week 12, week 24	A test of verbal memory
Change in score on the Brief Visuospatial Memory Test Revised (BVMT-R)	Baseline, week 12, week 24	A test of visuospatial memory
Change in score on the Cognitive Leisure and Activity Scale (CLAS)	Baseline, week 12, week 24, week 36	A questionnaire assessing the participant's degree of participation in cognitive leisure activities. The scale consists of 16 items (leisure activities) on which participants rate their activity level on a scale from 0-5, with 0 indicating no participation and 5 indicating daily participation in the activity. Scores are summed, yielding a total score ranging from 0 - 80 with lower scores indicating less participation in cognitive leisure activities and higher scores indicating a higher degree of participation.
Change in score on the Word Fluency Test (phonological)	Baseline, week 12, week 24	A test of executive functioning and verbal fluency
Change in score on the Five-point Test	Baseline, week 12, week 24	A test of executive functioning

Trial Locations

Locations (1)

Danish Multiple Sclerosis Center, Copenhagen University Hospital, Rigshospitalet-Glostrup; 🇩🇰 Glostrup, Denmark