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NCT Number: NCT04694534

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Learning Memory Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Arras, Arras, Hauts-de-France, France

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About this study

Cognitive impairment affects 40 to 70% multiple sclerosis patients. This condition is characterized by slower information processing, associated with deficits in episodic memory, attention and executive functions. These disorders appear early, regardless of functional impairment, in "benign" forms and in clinically isolated syndromes of multiple sclerosis. These disruptions can have a significant impact in the socio-professional and personal life of patients and also in the quality of life (job loss risks, daily activities limitations).

Even if these disorders are now well documented, remediation strategies remain less studied. Some studies show that the "training" methods, often used, do not seem suitable for clinical monitoring, with benefits that do not persist over time. Despite their impact on daily life, no specific care for planning abilities, mental inhibition and flexibility, or even social cognition, have been well studied until today. The same is true concerning metacognitive abilities. Finally, remedial techniques are time consuming and difficult to adapt to patients still in professional activity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serious game

Diagnostic Test

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.

Usual HAS care

Diagnostic Test

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.

Primary outcomes

  1. Change in the California Verbal Learning Test (CVLT)

    Time frame: Change from baseline at 4 and 10 months

    The California Verbal Learning Test (CVLT) begins with the examiner reading a list of 16 words. Patients listen to the list and report as many of the items as possible.

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

    Time frame: Change from baseline at 4 and 10 months

    In the Brief Visuospatial/lMemory Test six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. Thus, scores range from 0 to 12.

  3. Change in the Symbol Digit Modalities Test (SDMT)

    Time frame: Change from baseline at 4 and 10 months

    The Symbol Digit Modalities Test (SDMT) presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Patients are asked to voice the digit associated with each symbol as rapidly as possible for 90 sec. There is a single outcome measure: the number correct.

Secondary outcomes

  1. Change in the Auditory-verbal spans in direct or reverse order

    Time frame: Change from baseline at 4 and 10 months

    This assessment is required to evaluate short time memory and working memory.

  2. Change in the Stroop Color-Word Test

    Time frame: Change from baseline at 4 and 10 months

    This assessment is required to evaluate inhibition capacities and sensitivity to interference.

  3. Change in the Trail Making Test

    Time frame: Change from baseline at 4 and 10 months

    This assessment is required to evaluate cognitive flexibility abilities.

  4. Change in the Categorical and phonemic verbal fluency test

    Time frame: Change from baseline at 4 and 10 months

    This test is required to evaluate the spontaneous flexibility abilities.

  5. Change in the Tower of London test

    Time frame: Change from baseline at 4 and 10 months

    This test is required to assess planning capacities.

  6. Change in the Commission test

    Time frame: Change from baseline at 4 and 10 months

    This test assesses planning skills in a greener context than the Tower of London test.

  7. Change in the Concentrated Attention Test

    Time frame: Change from baseline at 4 and 10 months

    This assessment is required to evaluate selective attention.

  8. Change in the Paced Auditory Serial Addition Task (PASAT)

    Time frame: Change from baseline at 4 and 10 months

    This assessment is required to evaluate information processing speed and sustained attention.

  9. Change in the Mac Nair Scale

    Time frame: Change from baseline at 4 and 10 months

    This self-evaluation is required to assess cognitive complaint. It is a 39-items questionnaire corresponding to symptoms. Every symptom is noted on an ordinal scale in 5 steps.It is a scale with 5 degrees of severity measuring the frequency of disorders as follows: 4 = very often, 3 = often, 2 = sometimes, 1 = rarely, 0 = never.

  10. Change in the IPA (Participation and Autonomy Impact) Form

    Time frame: Change from baseline at 4 and 10 months

    This test is focused on the subject social participation and autonomy. is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. The standard cut-off scores are as follows:

    0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.

  11. Change in the BDI-II Scale (Beck Depression Inventory II)

    Time frame: Change from baseline at 4 and 10 months

    This scale is required to assess participants depressive orders. This is a 21-items self-questionnaire. Every item is rated from 0 (no problem) to 3 (maximum symptom severity). The depressive syndrome severity total score presents 4 intensity levels : 0-11 (no depression), 12-19 (mild depression), 20-27 (medium depression), 27 (severe depression).

  12. Change in the State-Trait Anxiety Inventory (STAI Y)

    Time frame: Change from baseline at 4 and 10 months

    This scale is used to evaluate the participants level anxiety. It is a 20-items questionnaire. The patients identifie the frequency with which they usually feel the symptoms listed on a four-point Likert-type scale variant from 1: "never" on the 1 point side to 4: "always" on the 4 point side.

    The overall score varies between 20 and 80.

  13. Change in the Visual Analogue Scale for Fatigue

    Time frame: Change from baseline at 4 and 10 months

    This scale allows patients to assess their fatigue. The patients locate their fatigue intensity on a 100-millimeters horizontal line.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

  14. Change in the Apparent validity

    Time frame: Change from baseline at 4 and 10 months

    Face validity is based on a subjective assessment of the instrument's validity to assess the patient's attitude towards the tool, its degree of involvement and its acceptability.

  15. Change in the EDSS score (Expanded disability status scale)

    Time frame: Change from baseline at 4 and 10 months

    This score is required to assess the patients functional and neurological level disability. This scale stretchs from 0 (no complaint and normal examen) to 10 (death caused by MS). The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.

  16. Frequency of game play per Week (in days)

    Time frame: Observance at 4 months

    This outcome is required to evaluate the instructions observance and play practices.

  17. Game session lenght

    Time frame: Observance at 4 months

    This outcome is required to evaluate the instructions observance and play practices.

  18. Time spent gaming

    Time frame: Observance at 4 months

    This outcome is required to evaluate the instructions observance and play practices.

  19. Game performance : tests number per exercise

    Time frame: Observance at 4 months

    This outcome is required to evaluate the instructions observance and play practices. The performance will be evaluated by the tests number per exercise.

  20. Game performance : difficulty levels

    Time frame: Observance at 4 months

    This outcome is required to evaluate the instructions observance and play practices. The performance will be evaluated by the difficulty levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Amélie Lausiaux, MD, PhD

CONTACT

[email protected]

03.20.22.52.69

Elodie Moutailler

CONTACT

[email protected]

03.20.22.52.69

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

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

Acronym: E-SEP

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jan 5, 2021
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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