NCT07474129

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
46mo left

Started Jun 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

March 11, 2026

Last Update Submit

March 11, 2026

Conditions

Multiple Sclerosis (MS)

Keywords

Multiple sclerosisSerious GameCognitive rehabilitationMagnetic resonance imaging

Outcome Measures

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.

    5 months

Study Arms (1)

Serious Game-based cognitive rehabilitation in multiple sclerosis patients

EXPERIMENTAL

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

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.

Serious Game-based cognitive rehabilitation in multiple sclerosis patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bruno LENNE

    Hôpital Saint Philibert, GHICL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Paule LEBITASY

CONTACT

+33320225741urm@ghicl.net

Lucile POISSON

CONTACT

+33320225902poisson.lucile@ghicl.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: The patients will be their own witness, with the reference state being that at the time of inclusion, before the start of treatment with the Serious Game.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share