Multiple Sclerosis (MS)REVEILLENCT07474129
Serious Game Rehabilitation and Brain Plasticity in MS
A study testing Serious Game in people with Multiple Sclerosis (MS), run by Lille Catholic University.
Trial summary
This prospective, interventional, longitudinal, multicentre study aims to evaluate the impact of the "Serious game", an innovative cognitive remediation tool on brain reorganization in Multiple sclerosis patients, using functional Magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis (MS)
- What is being tested?
- Serious Game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Mar 2030
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with relapsing-remitting or progressive MS defined according to the 2010 revised McDonald criteria [56]
- Cognitive complaints and deficits in at least one score on the initial neuropsychological examination (<5th percentile of the reference group)
- Aged between ≥ 18 and ≤ 65 years
- No defined relapse for at least 6 weeks
- At least 4 weeks since a corticosteroid bolus
- Patient with an internet connection
- Patient covered by social security
- Signed informed consent
Who cannot join
- Claustrophobia preventing MRI;
- Contraindication to MRI;
- Wearing fixed dental braces;
- Unable to receive oral and written information;
- Unable to use the software (due in particular to motor and/or sensory difficulties);
- Neurological or psychiatric comorbidity, other than MS and anxiety-depression syndrome,
Show all 11Show fewer
- Patient with severe anxiety-depression syndrome (BDI-FS > 10),
- Pregnant or breastfeeding women
- Taking neuroleptic treatment
- Person under guardianship or curatorship
- Person deprived of liberty
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Brain Reorganization After Serious Game -Based Cognitive Rehabilitation in Multiple Sclerosis
This prospective, interventional, longitudinal, multicentre study aims to evaluate the impact of the "Serious game", an innovative cognitive remediation tool on brain reorganization in Multiple sclerosis patients, using functional Magnetic resonance imaging (MRI). The serious game is a tool combining the motivational mechanisms of video games with cognitive remediation techniques.
- Conditions
- Multiple Sclerosis (MS)
- Being tested
- Serious Game
- Keywords
- Multiple sclerosis, Serious Game, Cognitive rehabilitation, Magnetic resonance imaging
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious GameOther
Specifically for the study, patients will undergo two morphological and functional MRI scans (at rest and during activation) on the 3T MRI scanner at St Philibert Hospital at M0 and M4. In addition, two neuropsychological assessments will be carried out specifically at M0 and M4. The additional time required to complete these examinations is approximately 2½ hours.
| Study group | Role | What they receive |
|---|---|---|
| Serious Game-based cognitive rehabilitation in multiple sclerosis patients | Experimental | Specifically for the study, patients will undergo two morphological and functional MRI scans (at rest and during activation) on the 3T MRI scanner at St Philibert Hospital at M0 and M4.
In addition, two neuropsychological assessments will be carried out specifically at M0 and M4. The additional time required to complete these examinations is approximately 2½ hours. Receives: Other: Serious Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean activation of the brain region involved in the functional network
The mean activation of each brain region involved in the functional network, will be measured using by functional MRI (fMRI) in patients with relapsing-remitting or progressive MS before and after Serious game. For each participant, a generalized linear model will be applied with the activation paradigm as a regressor to generate individual brain activation maps related to the functional task. The average activation values extracted from the regions of interest within the functional network will serve as the quantitative measure for statistical analyses.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startJun 2026 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The patients will be their own witness, with the reference state being that at the time of inclusion, before the start of treatment with the Serious Game.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno LENNE, Principal investigator, Hôpital Saint Philibert, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474129
- Sponsor's protocol ID
- RC-P00132
- Acronym
- REVEILLE
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Reorganization After Serious Game -Based Cognitive Rehabilitation in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07474129
- Acronym / sponsor ID
- REVEILLE / RC-P00132
- Conditions
- Multiple Sclerosis (MS)
- Keywords
- Multiple sclerosis, Serious Game, Cognitive rehabilitation, Magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 16 Mar 2026 (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.
This prospective, interventional, longitudinal, multicentre study aims to evaluate the impact of the "Serious game", an innovative cognitive remediation tool on brain reorganization in Multiple sclerosis patients, using functional Magnetic resonance imaging (MRI). The serious game is a tool combining the motivational mechanisms of video games with cognitive remediation techniques.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patients will be their own witness, with the reference state being that at the time of inclusion, before the start of treatment with the Serious Game.
| Arm | Type | Receives |
|---|---|---|
| Serious Game-based cognitive rehabilitation in multiple sclerosis patients | Experimental | Other: Serious GameSpecifically for the study, patients will undergo two morphological and functional MRI scans (at rest and during activation) on the 3T MRI scanner at St Philibert Hospital at M0 and M4. In addition, two neuropsychological assessments will be carried out specifically at M0 and M4. The additional time required to complete these examinations is approximately 2½ hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- People with relapsing-remitting or progressive MS defined according to the 2010 revised McDonald criteria [56]
- Cognitive complaints and deficits in at least one score on the initial neuropsychological examination (<5th percentile of the reference group)
- Aged between ≥ 18 and ≤ 65 years
- No defined relapse for at least 6 weeks
- At least 4 weeks since a corticosteroid bolus
Key exclusion criteria (11 listed)
- Claustrophobia preventing MRI;
- Contraindication to MRI;
- Wearing fixed dental braces;
- Unable to receive oral and written information;
- Unable to use the software (due in particular to motor and/or sensory difficulties);
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 |
|---|---|---|
| Serious GameSpecifically for the study, patients will undergo two morphological and functional MRI scans (at rest and during activation) on the 3T MRI scanner at St Philibert Hospital at M0 and M4. In addition, two neuropsychological assessments will be carried out specifically at M0 and M4. The additional time required to complete these examinations is approximately 2½ hours. | Other | Serious Game-based cognitive rehabilitation in multiple sclerosis patients |
Primary outcome
Mean activation of the brain region involved in the functional network
Time frame: 5 months
The mean activation of each brain region involved in the functional network, will be measured using by functional MRI (fMRI) in patients with relapsing-remitting or progressive MS before and after Serious game. For each participant, a generalized linear model will be applied with the activation paradigm as a regressor to generate individual brain activation maps related to the functional task. The average activation values extracted from the regions of interest within the functional network will serve as the quantitative measure for statistical analyses.
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 16 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis (MS)
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
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.
Bruno LENNE principal investigator
Hôpital Saint Philibert, GHICL
Questions about this trial
What is this clinical trial studying?
A study testing Serious Game in people with Multiple Sclerosis (MS), run by Lille Catholic University.
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 8 inclusion and 11 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: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Marie Paule LEBITASY (+33320225741, urm@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean activation of the brain region involved in the functional network (time frame: 5 months). 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 16 Mar 2026.