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Completed

NCT Number: NCT05691192

Cognitive Reserve-building Activities in Multiple Sclerosis

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Glostrup Municipality, 2600, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Leisure Activities

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.

Primary outcomes

  1. Change in score on the Symbol Digit Modality Test (SDMT)

    Time frame: Baseline, week 12, week 24

    An objective measure of cognitive efficiency

  2. Change in score on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)

    Time frame: Baseline, week 12, week 24

    A subjective measure of cognitive symptoms for patients with MS

Secondary outcomes

  1. Change in score on the California Verbal Learning Test II (CVLT II)

    Time frame: Baseline, week 12, week 24

    A test of verbal memory

  2. Change in score on the Brief Visuospatial Memory Test Revised (BVMT-R)

    Time frame: Baseline, week 12, week 24

    A test of visuospatial memory

  3. Change in score on the Word Fluency Test (phonological)

    Time frame: Baseline, week 12, week 24

    A test of executive functioning and verbal fluency

  4. Change in score on the Five-point Test

    Time frame: Baseline, week 12, week 24

    A test of executive functioning

  5. Change in score on the Cognitive Leisure and Activity Scale (CLAS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

Cognitive Reserve-building Activities in Multiple Sclerosis: a Randomized Controlled Trial of the Effect of Cognitive Leisure Activities on Objective and Subjective Measures of Cognition

Acronym: CRAMS

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jan 19, 2023
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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