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

RecruitingNot a drug-phase studyRelapsing and progressiveNCT04694534

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Serious game

Placebo

  • Usual HAS care

What it measured

Main measures

  • Change in the California Verbal Learning Test (CVLT)

    Change from baseline at 4 and 10 months

  • Change in the Brief Visuo-spatial Memory Test (BVMT)

    Change from baseline at 4 and 10 months

    Thinking and memory
  • Change in the Symbol Digit Modalities Test (SDMT)

    Change from baseline at 4 and 10 months

    Thinking and memory

Other measures (20)

  • Change in the Auditory-verbal spans in direct or reverse order

    Change from baseline at 4 and 10 months

    Thinking and memory
  • Change in the Stroop Color-Word Test

    Change from baseline at 4 and 10 months

  • Change in the Trail Making Test

    Change from baseline at 4 and 10 months

    Thinking and memory
  • Change in the Categorical and phonemic verbal fluency test

    Change from baseline at 4 and 10 months

  • Change in the Tower of London test

    Change from baseline at 4 and 10 months

  • Change in the Commission test

    Change from baseline at 4 and 10 months

  • Change in the Concentrated Attention Test

    Change from baseline at 4 and 10 months

    Thinking and memory
  • Change in the Paced Auditory Serial Addition Task (PASAT)

    Change from baseline at 4 and 10 months

    Thinking and memory
  • Change in the Mac Nair Scale

    Change from baseline at 4 and 10 months

    Thinking and memory
  • Change in the IPA (Participation and Autonomy Impact) Form

    Change from baseline at 4 and 10 months

    Mood and sleep

Who could take part

Relapsing and progressive · 18 to 65

Show the full criteria

Inclusion criteria

* 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 criteria

* 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

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Oct 2021

    2. Main results due

      Apr 2026

    3. Finished

      Mar 2027

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