Serious Game Rehabilitation and Brain Plasticity in MS

N/ANot Yet RecruitingNCT07474129

Lille Catholic University40 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis (MS)

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 5 months

Central Contacts

Marie Paule LEBITASY

CONTACT

+33320225741 urm@ghicl.net

Lucile POISSON

CONTACT

+33320225902 poisson.lucile@ghicl.net

Data from ClinicalTrials.gov

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