NCT04694534

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Lille Catholic University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Multiple Sclerosis
• Memory
• Learning

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2021-10-08
• Primary completion: 2026-04-04
• Completion: 2027-03-01
• First posted: 2021-01-05
• Last updated: 2025-09-04

Locations

6 sites across 1 country: France