Neurorehabilitation of Cognitive Deficits in Multiple Sclerosis Using an Adaptive Cognitive Exergame - Randomized, Controlled, Multi-center Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Body Brain Trainer software, RehaCom software.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Neurorehabilitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- PDQ-20 [Time frame: End of training period (4 weeks).]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07086950 · REALISE-MS