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

NCT07086950 | Not Yet Recruiting Early Phase 1

• 1 other identifier: REALISE-MS
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• PDQ-20

  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.

  End of training period (4 weeks).

Study Arms (2)

Body Brain Trainer software

EXPERIMENTAL

Device: Body Brain Trainer software

RehaCom software

ACTIVE COMPARATOR

Device: RehaCom software

Interventions

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.

Body Brain Trainer software

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.

RehaCom software

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Prof. Arseny Sokolov, MD, PhD: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair and Full Professor of Neurorehabilitation

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share