Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID04694534

e-SEP Cognition: Effectiveness of a Remediation Program Via a "Serious Game" on the Cognitive Functions of Multiple Sclerosis Patients: Controlled, Randomized, Multicentric Trial

Led by Lille Catholic University · Updated on 2025-09-04

150

Participants Needed

6

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effectiveness of a cognitive remediation program using a "serious game" to improve information processing speed and episodic memory learning in adults with multiple sclerosis. Cognitive impairment affects 40 to 70% of these patients and leads to slower processing, memory, attention, and executive function difficulties, impacting their daily and work life. The study addresses the need for practical, adaptable remediation strategies, as current training methods show limited lasting benefits and are time-consuming. Participants will be randomly assigned to one of two groups: one receiving classic care recommended by French health authorities plus cognitive remediation through a serious game accessed via an online tablet platform, involving four 20-minute activity sessions per week; the other group will receive classic care alone with non-specific cognitive activity notebooks and similar session instructions. The serious game format targets multiple cognitive functions simultaneously, and the intervention period lasts four months. During the study, participants will undergo neuropsychological evaluations at baseline, 4 months, and 10 months to measure changes in several cognitive tests including verbal learning, visuospatial memory, and processing speed. Researchers will also monitor game play frequency, session length, performance, and various secondary cognitive and quality of life measures. Participants will be followed to assess the durability of cognitive changes and overall impact on autonomy and mood throughout the study period.

CONDITIONS

Brief Title

Remediation Program Via a "Serious Game" for the Cognitive Functions of Multiple Sclerosis Patients

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Diagnosed with relapsing-remitting or progressive multiple sclerosis according to Mc Donald's 2005 criteria
  • Cognitive complaints with at least one deficient score on initial neuropsychological testing, including at least one BICAMS test
  • No definite relapse in the last 6 weeks
  • At least 4 weeks since last corticosteroid bolus
  • No neuroleptic treatment
  • Access to an internet connection
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Severe cognitive deficit with more than six deficient cognitive process scores at initial assessment
  • Receiving neuropsychological care
  • Unable to understand or receive oral and written information
  • Unable to use the software due to motor or sensory difficulties
  • Neurological or psychiatric conditions other than multiple sclerosis and anxiodepressive syndrome
  • Severe anxiodepressive syndrome (BDI > 27)
  • Participation in another interventional cognitive function study
  • Under legal protection, guardianship, or curatorship
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 4 months

Participants undergo cognitive testing and assessments to evaluate their cognitive functions before starting the remediation program.

Weekly visits for up to 4 months

Long-term Monitoring

Duration - 6 months after initial 4 months

Participants are monitored for changes in cognitive function and other outcomes through assessments at 4 and 10 months after baseline.

2 visits (at 4 and 10 months)

Trial Site Locations

Total: 6 locations

1

CH Arras

Arras, Hauts-de-France, France, 62000

Actively Recruiting

2

CH LENS

Lens, Hauts-de-France, France, 62300

Actively Recruiting

3

CHRU

Lille, Hauts-de-France, France, 59000

Actively Recruiting

4

Saint Vincent hospital

Lille, Hauts-de-France, France, 59000

Actively Recruiting

5

Saint-Philibert hospital

Lomme, Nord, France, 59462

Actively Recruiting

6

Charles Nicolle Hospital

Rouen, Normandy, France, 76000

Actively Recruiting

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Research Team

A

Amélie Lausiaux, MD, PhD

E

Elodie Moutailler

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Published Research Related To This Trial

Improving cognition in people with multiple sclerosis: study protocol for a multiarm, randomised, blinded trial of multidomain cognitive rehabilitation using a video-serious game (E-SEP cognition).

Bruno Lenne, Béatrice Degraeve, Jessy Davroux...

https://pubmed.ncbi.nlm.nih.gov/38033375