Serious Game Rehabilitation and Brain Plasticity in MS (REVEILLE)

Lille Catholic University

Status: Begins enrollment in 1 month

Conditions: Multiple Sclerosis (MS)

Treatments: Other: Serious Game

Study type: Interventional

Funder types: Other

Identifiers

NCT07474129

RC-P00132

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Serious Game-based cognitive rehabilitation in multiple sclerosis patients

Experimental group

Description:

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.

Treatment:

Other: Serious Game