Cognitive Reserve-building Activities in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— CRAMS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05691192
• Other study ID #: H-20075846
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: Andreas K Færk
• Phone: +4538633205
• Email: andreas.kirknaes.faerk.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Denmark	Danish Multiple Sclerosis Center, Copenhagen University Hospital, Rigshospitalet-Glostrup	Glostrup

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in score on the Symbol Digit Modality Test (SDMT)	An objective measure of cognitive efficiency	Baseline, week 12, week 24
Primary	Change in score on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)	A subjective measure of cognitive symptoms for patients with MS	Baseline, week 12, week 24
Secondary	Change in score on the California Verbal Learning Test II (CVLT II)	A test of verbal memory	Baseline, week 12, week 24
Secondary	Change in score on the Brief Visuospatial Memory Test Revised (BVMT-R)	A test of visuospatial memory	Baseline, week 12, week 24
Secondary	Change in score on the Word Fluency Test (phonological)	A test of executive functioning and verbal fluency	Baseline, week 12, week 24
Secondary	Change in score on the Five-point Test	A test of executive functioning	Baseline, week 12, week 24
Secondary	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.	Baseline, week 12, week 24, week 36

External Links

•   Full study protocol with all references