Serious Game Rehabilitation and Brain Plasticity in MS

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.

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Key information

Conditions

Multiple Sclerosis (MS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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,
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

Treatment and study plan

Serious game

Other

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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lucile POISSON

CONTACT

[email protected]

+33320225902

Marie Paule LEBITASY

CONTACT

[email protected]

+33320225741

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

Brain Reorganization After Serious Game -Based Cognitive Rehabilitation in Multiple Sclerosis

Acronym: REVEILLE

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2030
First posted: Mar 16, 2026
Registry last updated: Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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