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

Prof. Arseny Sokolov, MD, PhD

Status and phase: Begins enrollment this month; Early Phase 1

Conditions: Multiple Sclerosis; Neurorehabilitation

Treatments: Device: RehaCom software; Device: Body Brain Trainer software

Study type: Interventional

Funder types: Other

Identifiers

NCT07086950

REALISE-MS

Details and patient eligibility

About

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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Informed Consent signed by the participant,
2. Adults 18+ years,
3. 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),
4. Presence of cognitive complaint,
5. Z-Score ≤ -0.5 in the Symbol Digit Modalities Test (SDMT)

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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190 participants in 2 patient groups

Body Brain Trainer software

Experimental group

Treatment:

Device: Body Brain Trainer software

RehaCom software

Active Comparator group

Treatment:

Device: RehaCom software