Multiple SclerosisPhase 2CRAMSNCT05691192
Cognitive Reserve-building Activities in Multiple Sclerosis
A Phase 2 study testing Cognitive Leisure Activities in people with Multiple Sclerosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The study is a crossover randomized controlled trial investigating the effect of increasing engagement in cognitive leisure activities for individuals with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Cognitive Leisure Activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2022to 12 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Danish Multiple Sclerosis Center, Copenhagen University Hospital, Rigshospitalet-Glostrup
Glostrup Municipality, 2600
About this study
Official 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
The study is a crossover randomized controlled trial investigating the effect of increasing engagement in cognitive leisure activities for individuals with multiple sclerosis.
Read the 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
- Being tested
- Cognitive Leisure Activities
- Keywords
- Cognition, Multiple Sclerosis, Cognitive Rehabilitation, Cognitive Reserve, Cognitive Leisure Activities, Leisure Activities, Intellectual Enrichment, Relapsing-remitting multiple sclerosis, Secondary progressive multiple sclerosis, Progressive multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Leisure ActivitiesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Leisure Activities | Experimental | 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. Receives: Behavioral: Cognitive Leisure Activities |
| Passive control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in score on the Symbol Digit Modality Test (SDMT)
An objective measure of cognitive efficiency
Measured: Baseline, week 12, week 24
Change in score on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)
A subjective measure of cognitive symptoms for patients with MS
Measured: Baseline, week 12, week 24
Secondary outcomes (5)
Change in score on the California Verbal Learning Test II (CVLT II)
A test of verbal memory
Measured: Baseline, week 12, week 24
Change in score on the Brief Visuospatial Memory Test Revised (BVMT-R)
A test of visuospatial memory
Measured: Baseline, week 12, week 24
Change in score on the Word Fluency Test (phonological)
A test of executive functioning and verbal fluency
Measured: Baseline, week 12, week 24
Change in score on the Five-point Test
A test of executive functioning
Measured: Baseline, week 12, week 24
Change in score on the Cognitive Leisure and Activity Scale (CLAS)
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.
Measured: Baseline, week 12, week 24, week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Dec 2022
- Primary completion27 Nov 2024
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study will use a randomized, controlled crossover design to investigate the impact of cognitive leisure activities on cognitive function in individuals with multiple sclerosis (MS). 60 participants with RRMS or progressive MS (30 RRMS, 30 PPMS/SPMS) will be randomly assigned to either an intervention group (Group A) or a passive control group (Group B) for 12 weeks. Participants will be randomized using a computer-based random number generator in blocks of 6 based on MS subtype (RRMS/progressive MS). After the initial 12 weeks, the groups will be crossed over and followed for an additional 12 weeks. The passive control group will also receive an additional follow-up after 36 weeks. The total time from enrollment to last follow-up will be 24 weeks for Group A and 36 weeks for Group B.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Andreas Kirknæs Færk, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Andreas Kirknæs Færk, Principal investigator, Danish Multiple Sclerosis Center, Copenhagen University Hospital, Rigshospitalet-Glostrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691192
- Sponsor's protocol ID
- H-20075846
- Acronym
- CRAMS
- Status last verified
- Dec 2024
- First submitted
- 6 Jan 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05691192
- Acronym / sponsor ID
- CRAMS / H-20075846
- Conditions
- Multiple Sclerosis
- Keywords
- Cognition, Multiple Sclerosis, Cognitive Rehabilitation, Cognitive Reserve, Cognitive Leisure Activities, Leisure Activities, Intellectual Enrichment, Relapsing-remitting multiple sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will use a randomized, controlled crossover design to investigate the impact of cognitive leisure activities on cognitive function in individuals with multiple sclerosis (MS). 60 participants with RRMS or progressive MS (30 RRMS, 30 PPMS/SPMS) will be randomly assigned to either an intervention group (Group A) or a passive control group (Group B) for 12 weeks. Participants will be randomized using a computer-based random number generator in blocks of 6 based on MS subtype (RRMS/progressive MS). After the initial 12 weeks, the groups will be crossed over and followed for an additional 12 weeks. The passive control group will also receive an additional follow-up after 36 weeks. The total time from enrollment to last follow-up will be 24 weeks for Group A and 36 weeks for Group B.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Leisure Activities | Experimental | Behavioral: Cognitive Leisure ActivitiesParticipants 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. |
| Passive control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- RRMS, SPMS or PPMS
- Age 18-65
- EDSS score ≤ 6.5
- SDMT (or PASAT) score below -1 SD
- No depression based on the MDI
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Leisure ActivitiesParticipants 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. | Behavioural | Cognitive Leisure Activities |
Primary outcome
Change in score on the Symbol Digit Modality Test (SDMT)
Time frame: Baseline, week 12, week 24
An objective measure of cognitive efficiency
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
5 secondary outcomes
Change in score on the California Verbal Learning Test II (CVLT II)
Time frame: Baseline, week 12, week 24
Change in score on the Brief Visuospatial Memory Test Revised (BVMT-R)
Time frame: Baseline, week 12, week 24
Change in score on the Word Fluency Test (phonological)
Time frame: Baseline, week 12, week 24
Change in score on the Five-point Test
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Full study protocol with all referencesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Kirknæs Færk principal investigator
Danish Multiple Sclerosis Center, Copenhagen University Hospital, Rigshospitalet-Glostrup
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive Leisure Activities in people with Multiple Sclerosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in score on the Symbol Digit Modality Test (SDMT) (time frame: Baseline, week 12, week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.