Cognitive Reserve-building Activities in Multiple Sclerosis (CRAMS)

April 8, 2024 updated by: Andreas Kirknæs Færk, Rigshospitalet, Denmark

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in score on the Symbol Digit Modality Test (SDMT)
Time Frame: Baseline, week 12, week 24
An objective measure of cognitive efficiency
Baseline, week 12, week 24
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
Baseline, week 12, week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in score on the California Verbal Learning Test II (CVLT II)
Time Frame: Baseline, week 12, week 24
A test of verbal memory
Baseline, week 12, week 24
Change in score on the Brief Visuospatial Memory Test Revised (BVMT-R)
Time Frame: Baseline, week 12, week 24
A test of visuospatial memory
Baseline, week 12, week 24
Change in score on the Word Fluency Test (phonological)
Time Frame: Baseline, week 12, week 24
A test of executive functioning and verbal fluency
Baseline, week 12, week 24
Change in score on the Five-point Test
Time Frame: Baseline, week 12, week 24
A test of executive functioning
Baseline, week 12, week 24
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.
Baseline, week 12, week 24, week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

University of Copenhagen

Investigators

  • Principal Investigator: Andreas Kirknæs Færk, Danish Multiple Sclerosis Center, Copenhagen University Hospital, Rigshospitalet-Glostrup

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20075846

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on Cognitive Leisure Activities

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe