Multiple SclerosisREALISE-MSNCT07086950
Neurorehabilitation of Cognitive Deficits in Multiple Sclerosis Using an Adaptive Cognitive Exergame
A study testing Body Brain Trainer software and RehaCom software in people with Multiple Sclerosis and Neurorehabilitation, run by Prof. Arseny Sokolov, MD, PhD at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Neurorehabilitation
- What is being tested?
- Body Brain Trainer software and RehaCom software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Feb 2026to 30 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)),
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Service universitaire de neuroréhabilitation
Lausanne, Canton of Vaud, 1011
Arseny Sokolov, Prof., +41213142390, aresny.sokolov@chuv.ch
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis, Neurorehabilitation
- Being tested
- Body Brain Trainer software, RehaCom software
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Brain Trainer softwareDevice
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 softwareDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Body Brain Trainer software | Experimental | Not described Receives: Device: Body Brain Trainer software |
| RehaCom software | Active comparator | Not described Receives: Device: RehaCom software |
What is being measured
The primary outcome is the main question the study is designed to answer.
PDQ-20, Perceived Deficits Questionnaire Scores: 0 - 80 Higher Scores = More Deficits
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.
Measured: End of training period (4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start5 Feb 2026
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Arseny Sokolov, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Arseny Sokolov, MD, PhD, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086950
- Sponsor's protocol ID
- REALISE-MS
- Acronym
- REALISE-MS
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurorehabilitation of Cognitive Deficits in Multiple Sclerosis Using an Adaptive Cognitive Exergame - Randomized, Controlled, Multi-center Clinical Trial
- ClinicalTrials.gov ID
- NCT07086950
- Acronym / sponsor ID
- REALISE-MS / REALISE-MS
- Conditions
- Multiple Sclerosis, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Prof. Arseny Sokolov, MD, PhDUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body Brain Trainer software | Experimental | Device: Body Brain Trainer software |
| RehaCom software | Active comparator | Device: RehaCom software |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Brain Trainer softwarePatients 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 | Body Brain Trainer software |
| RehaCom softwarePatients 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. | Device | RehaCom software |
Primary outcome
PDQ-20, Perceived Deficits Questionnaire Scores: 0 - 80 Higher Scores = More Deficits
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Brain Trainer software and RehaCom software in people with Multiple Sclerosis and Neurorehabilitation, run by Prof. Arseny Sokolov, MD, PhD at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arseny Sokolov, Prof (+41213142390, aresny.sokolov@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PDQ-20, Perceived Deficits Questionnaire Scores: 0 - 80 Higher Scores = More Deficits (time frame: End of training period (4 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.