Serious Game Rehabilitation and Brain Plasticity in MS
ConditionMultiple Sclerosis (MS)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLille Catholic University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Claustrophobia preventing MRI;
Contraindication to MRI;
Wearing fixed dental braces;
Unable to receive oral and written information;
Trial design
Design model
Single group
Treatments tested in this trial
Serious Game
Other interventionSpecifically 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 groups
40 Participants
are divided into 1 treatment groupGroup A: Serious Game-based cognitive rehabilitation in multiple sclerosis patientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: