Clinical trial NCT05691192: Cognitive Reserve-building Activities in Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
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
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2023-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in score on the Symbol Digit Modality Test (SDMT)
timeFrame: Baseline, week 12, week 24
measure: Change in score on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)
timeFrame: Baseline, week 12, week 24
Secondary outcomes:
measure: Change in score on the California Verbal Learning Test II (CVLT II)
timeFrame: Baseline, week 12, week 24
measure: Change in score on the Brief Visuospatial Memory Test Revised (BVMT-R)
timeFrame: Baseline, week 12, week 24
measure: Change in score on the Word Fluency Test (phonological)
timeFrame: Baseline, week 12, week 24
measure: Change in score on the Five-point Test
timeFrame: Baseline, week 12, week 24
measure: Change in score on the Cognitive Leisure and Activity Scale (CLAS)
timeFrame: Baseline, week 12, week 24, week 36
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Multiple Sclerosis Center, Copenhagen University Hospital, Rigshospitalet-Glostrup
Study officials:
affiliation: Danish Multiple Sclerosis Center, Copenhagen University Hospital, Rigshospitalet-Glostrup
name: Andreas Kirknæs Færk
role: PRINCIPAL_INVESTIGATOR
References: