RecruitingNot ApplicableNCT04694534

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

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


Sponsor

Lille Catholic University

Enrollment

150 participants

Start Date

Oct 8, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The main goal of this study is to assess the effectiveness of a cognitive remediation program based on a "serious game" on the information processing speed evolution and the process of learning via episodic memory in multiple sclerosis patients.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria8

  • Relapsing-remitting or progressive multiple sclerosis people defined according to Mc Donald's criteria revised in 2005
  • Age between ≥ 18 and ≤ 65 years old
  • Cognitive complaint, with at least one deficient score at the initial neuropsychological examination (\<5th percentile of the reference group), one of the scores of which concerns at least one BICAMS test
  • Have not had a definite relapse for at least 6 weeks
  • Be at least 4 weeks away from a corticosteroid bolus
  • Lack of neuroleptic treatment
  • Patient with an Internet connection
  • Signed informed consent

Exclusion Criteria9

  • Severe cognitive deficit defined by obtaining a deficit score in more than six cognitive processes at the initial neuropsychological assessment.
  • Neuropsychological care
  • Inability to receive oral and written information
  • Inability to use the software (due in particular to motor and / or sensory difficulties),
  • Neurological or psychiatric comorbidity, other than MS and anxiodepressive syndrome
  • Patient with severe anxiodepressive syndrome (BDI\> 27)
  • Participation in an interventional study on cognitive functions
  • Patient under legal protection, guardianship or curatorship
  • Pregnant or breastfeeding women

Interventions

DIAGNOSTIC_TESTSerious game

The serious game is accessible via an online platform, on a tablet: 4 20-minutes activities sessions per week must be carried out. The program format in the serious game form makes possible to simultaneously understand a large number of cognitive functions.

DIAGNOSTIC_TESTUsual HAS care

The control group patients will follow the care they need, according to the HAS recommendations. Non-specific cognitive activities notebooks will be provided to them. They will be instructed to perform the 4 20-minutes sessions per week for 4 months.


Locations(6)

CH Arras

Arras, Hauts-de-France, France

CH LENS

Lens, Hauts-de-France, France

CHRU

Lille, Hauts-de-France, France

Saint Vincent hospital

Lille, Hauts-de-France, France

Saint-Philibert hospital

Lomme, Nord, France

Charles Nicolle Hospital

Rouen, Normandy, France

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NCT04694534


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