Serious Game Rehabilitation and Brain Plasticity in MS
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: Serious Game.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis (MS). Basic parameters: 18 years — 65 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 →
Unsure about the terms? Read our patient guide →
Official title
Brain Reorganization After Serious Game -Based Cognitive Rehabilitation in Multiple Sclerosis
Overview
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.
Interventions
- Other Serious Game
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 outcome measures
- Mean activation of the brain region involved in the functional network [Time frame: 5 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07474129 · RC-P00132