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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Neurorehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Informed Consent signed by the participant,
Adults 18+ years,
Patients with a diagnosis of relapsing multiple sclerosis according to the most recent internationally recognized criteria, as evaluated by their treating physicians (Thompson et al., 2018) or secondary progressive MS (diagnosis ≤ 30 months),
Presence of cognitive complaint,
Z-Score ≤ -0.5 in the Symbol Digit Modalities Test (SDMT)

Exclusion criteria

Clinically or radiologically confirmed MS relapses within 3 months prior to enrollment,
Change in disease modifying treatments (DMT), antidepressant or anxiolytic medication within 1 month prior to enrollment,
High risk of falls based on a completion time of more than 15 seconds in the Four Square Step Test (FSST) (Dite & Temple, 2002),
Assisted locomotion or falls in the past 3 months as evaluated in the enrollment interview (Hopkins Falls Grading Scale (Grade > 1)),
Major psychiatric and/or neurocognitive disorders according to the DSM-5 (APA, 2013),
Incapacity to discriminate colors (Ishihara test; (Clark, 1924)),
Insufficient language knowledge to understand instructions or questionnaires,
High-risk pregnancy as evaluated by the appointed gynecologist.
Z-Score ≤ -3.5 in the Symbol Digit Modalities Test (SDMT).

Treatment and study plan

Body Brain Trainer software

Device

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.

RehaCom software

Device

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.

Primary outcomes

PDQ-20

Time frame: End of training period (4 weeks).

The primary endpoint of this clinical trial is the change in subjective cognitive dysfunction, as measured by the Perceived Deficits Questionnaire-20 (PDQ-20) total score, in people with multiple sclerosis using exergame (BBT) compared to RehaCom (control) from baseline to end-of-training.

Sponsors and collaborators

Lead sponsor

Prof. Arseny Sokolov, MD, PhD

Other

Registry information

Acronym: REALISE-MS

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Jul 25, 2025
Registry last updated: Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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