NCT07086950

Neurorehabilitation of Cognitive Deficits in Multiple Sclerosis Using an Adaptive Cognitive Exergame - Randomized, Controlled, Multi-center Clinical Trial

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Prof. Arseny Sokolov, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Multiple Sclerosis
• Neurorehabilitation

Interventions

Type	Name	Description
DEVICE	Body Brain Trainer software	Patients will engage in cognitive and physical exercises with the training software Body Brain Training (BBT) for 4 consecutive weeks. Participants will be asked to complete 3 sessions per week for a length of \~1h per session.
DEVICE	RehaCom software	Patients will engage in exercises with the cognitive training software RehaCom (Hasomed®), which is a proxy to the standard of care, for 4 consecutive weeks. Participants will be asked to complete 3 sessions per week for a length of \~1h per session.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2025-07-25
• Last updated: 2025-07-25