Neurorehabilitation of Cognitive Deficits in Multiple Sclerosis Using an Adaptive Cognitive Exergame

Study acronym: REALISE-MS
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 4 months later Jun 30, 2028 → Oct 30, 2028
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Prof. Arseny Sokolov, MD, PhD

Record History

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  1. Primary endpoint(s) modified Show 6 more changesShow less
    • Phase changed: Early Phase 1 → not applicable
    • Recruitment opened
    • Start date changed from estimate of Sep 1, 2025 to Feb 5, 2026
    • Primary and study completion pushed from Jun 30, 2028 to Oct 30, 2028
    • Eligibility criteria expanded, about 14 words
    • Study title shortened, about 6 words
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Approximately 2.8 million people worldwide suffer from multiple sclerosis (MS). In 40 to 70% of cases, individuals with MS experience cognitive impairments that significantly interfere with their personal lives, careers, and quality of life. Current pharmacological and neurorehabilitation treatment options do not adequately reduce cognitive deficits. The absence of standards of care in Switzerland or internationally regarding cognitive neurorehabilitation in MS highlights the need for effective interventions with lasting effects. To address this need, we are exploring different approaches to support and improve cognitive impairments through training exercises using computerized tools. Traditionally, these exercises are in paper-and-pencil format, consisting of tests, puzzles, and memory tasks. While this approach is useful, computerized tools now allow us to offer more playful, interactive, and engaging approaches. In this study, we are examining the effect of serious video games (a medical device) on cognitive deficits related to MS. The serious video games we are testing have already been evaluated at CHUV in individuals with MS and cognitive impairments. This recent study demonstrated the feasibility and safety of using these games in people with MS. With the current study, we aim to test these tools on a larger scale in order to better understand their effects on cognitive functions. More specifically, we seek to determine which of the two proposed interventions provides the greatest cognitive benefits.
Trial Details
NCT Number NCT07086950
Lead Sponsor Prof. Arseny Sokolov, MD, PhD
Conditions
(from sponsor)		 Multiple Sclerosis, Neurorehabilitation
Related terms Multiple Sclerosis
Enrollment 190 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov