Remediation Program Via a "Serious Game" for the Cognitive Functions of Multiple Sclerosis Patients (E-SEP)

Lille Catholic University

Status: Enrolling

Conditions: Learning; Multiple Sclerosis; Memory

Treatments: Diagnostic Test: Serious game; Diagnostic Test: Usual HAS care

Study type: Interventional

Funder types: Other

Identifiers

NCT04694534

RC-P0066

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups, including a placebo group

Remediation program via a "serious game"

Experimental group

Description:

Classic care (recommended by the French Haute Autorité de Santé) accompanied by cognitive remediation by "serious game"

Treatment:

Diagnostic Test: Serious game

Classic care (French Haute Autorité de Santé)

Placebo Comparator group

Description:

Classic care (recommended by French Haute Autorité de Santé)

Treatment:

Diagnostic Test: Usual HAS care