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Not yet recruitingNCT07474129REVEILLEUpdated Mar 16, 2026

Serious Game Rehabilitation and Brain Plasticity in MS

An interventional study of Serious Game in Multiple Sclerosis (MS), sponsored by Lille Catholic University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by Lille Catholic University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Multiple Sclerosis (MS)

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Keywords

  • Multiple sclerosis
  • Serious Game
  • Cognitive rehabilitation
  • Magnetic resonance imaging
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Serious Game-based cognitive rehabilitation in multiple sclerosis patients

    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.

    Other: Serious Game

Interventions

  • OtherSerious 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.

05

What researchers measure

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 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07474129
Lead sponsor
Lille Catholic University
Responsible party
Sponsor
First posted
Mar 16, 2026
Start date
Jun 2026 (estimated)
Primary completion
Mar 2030 (estimated)
Completion
Mar 2030 (estimated)
Last update
Mar 16, 2026

Study contacts

Marie Paule LEBITASY
Contact
urm@ghicl.net
+33320225741
Lucile POISSON
Contact
poisson.lucile@ghicl.net
+33320225902
Bruno LENNE
principal investigator · Hôpital Saint Philibert, GHICL

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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