Cognitive Reserve-building Activities in Multiple Sclerosis

NCT05691192 | Completed Phase 2

• 1 other identifier: H-20075846
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

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

  An objective measure of cognitive efficiency

  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

  Baseline, week 12, week 24

Secondary Outcomes (5)

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

  Baseline, week 12, week 24

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

  Baseline, week 12, week 24

• Change in score on the Word Fluency Test (phonological)

  Baseline, week 12, week 24

• Change in score on the Five-point Test

  Baseline, week 12, week 24

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

  Baseline, week 12, week 24, week 36

Study Arms (2)

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.

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.

Interventions

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.

Cognitive Leisure Activities

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• University of Copenhagen: collaborator

Study Sites (1)

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

Glostrup Municipality, 2600, Denmark

Location

Related Links

• Full study protocol with all references

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Kirknæs Færk

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded as to the participant's assigned intervention.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neuropsychologist, PhD student

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 19, 2023
• Study Start: December 1, 2022
• Primary Completion: November 27, 2024
• Study Completion: February 12, 2025
• Last Updated: February 18, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)