Remediation Program Via a "Serious Game" for the Cognitive Functions of Multiple Sclerosis Patients
NCT ID: NCT04694534
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2021-10-08
2027-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
1 Experimental group
DIAGNOSTIC
SINGLE
Study Groups
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Remediation program via a "serious game"
Classic care (recommended by the French Haute Autorité de Santé) accompanied by cognitive remediation by "serious game"
Serious 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.
Classic care (French Haute Autorité de Santé)
Classic care (recommended by French Haute Autorité de Santé)
Usual 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.
Interventions
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Serious 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.
Usual 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Lille Catholic University
OTHER
Responsible Party
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Principal Investigators
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Bruno Lenne
Role: PRINCIPAL_INVESTIGATOR
Hôpital Saint-Vincent de Paul
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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Lenne B, Degraeve B, Davroux J, Norberciak L, Kwiatkowski A, Donze C. 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). BMJ Neurol Open. 2023 Nov 27;5(2):e000488. doi: 10.1136/bmjno-2023-000488. eCollection 2023.
Other Identifiers
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RC-P0066
Identifier Type: -
Identifier Source: org_study_id
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