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

CompletedPhase 2Relapsing and progressiveNCT05691192

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Cognitive Leisure Activities

What it measured

Main measures

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

    Baseline, week 12, week 24

    Thinking and memory
  • Change in score on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)

    Baseline, week 12, week 24

    Thinking and memory

Other measures (5)

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

    Baseline, week 12, week 24

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

    Baseline, week 12, week 24

    Thinking and memory
  • 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

    Thinking and memory

Who could take part

Relapsing and progressive · 18 to 65

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

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History

    1. Started

      Dec 2022

    2. Main results due

      Nov 2024

    3. Finished

      Feb 2025

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