Clinical trial NCT04694534: Remediation Program Via a "Serious Game" for the Cognitive Functions of Multiple Sclerosis Patients
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Memory
Learning
Keywords: Multiple sclerosis
Serious game
Episodic memory learning capacities
Information processing speed capacities
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1 Control group

1 Experimental group
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility 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

Primary outcomes:
measure: Change in the California Verbal Learning Test (CVLT)
timeFrame: Change from baseline at 4 and 10 months
measure: Change in the Brief Visuo-spatial Memory Test (BVMT)
timeFrame: Change from baseline at 4 and 10 months
measure: Change in the Symbol Digit Modalities Test (SDMT)
timeFrame: Change from baseline at 4 and 10 months
Secondary outcomes:
measure: Change in the Auditory-verbal spans in direct or reverse order
timeFrame: Change from baseline at 4 and 10 months
measure: Change in the Stroop Color-Word Test
timeFrame: Change from baseline at 4 and 10 months
measure: Change in the Trail Making Test
timeFrame: Change from baseline at 4 and 10 months
measure: Change in the Categorical and phonemic verbal fluency test
timeFrame: Change from baseline at 4 and 10 months
measure: Change in the Tower of London test
timeFrame: Change from baseline at 4 and 10 months
measure: Change in the Commission test
timeFrame: Change from baseline at 4 and 10 months
measure: Change in the Concentrated Attention Test
timeFrame: Change from baseline at 4 and 10 months
measure: Change in the Paced Auditory Serial Addition Task (PASAT)
timeFrame: Change from baseline at 4 and 10 months
measure: Change in the Mac Nair Scale
timeFrame: Change from baseline at 4 and 10 months
measure: Change in the IPA (Participation and Autonomy Impact) Form
timeFrame: Change from baseline at 4 and 10 months
measure: Change in the BDI-II Scale (Beck Depression Inventory II)
timeFrame: Change from baseline at 4 and 10 months
measure: Change in the State-Trait Anxiety Inventory (STAI Y)
timeFrame: Change from baseline at 4 and 10 months
measure: Change in the Visual Analogue Scale for Fatigue
timeFrame: Change from baseline at 4 and 10 months
measure: Change in the Apparent validity
timeFrame: Change from baseline at 4 and 10 months
measure: Change in the EDSS score (Expanded disability status scale)
timeFrame: Change from baseline at 4 and 10 months
measure: Frequency of game play per Week (in days)
timeFrame: Observance at 4 months
measure: Game session lenght
timeFrame: Observance at 4 months
measure: Time spent gaming
timeFrame: Observance at 4 months
measure: Game performance : tests number per exercise
timeFrame: Observance at 4 months
measure: Game performance : difficulty levels
timeFrame: Observance at 4 months
Other outcomes:
Locations:
city: Arras
country: France
facility: CH Arras
state: Nord Pas De Calais
city: Lens
country: France
facility: CH LENS
state: Nord Pas De Calais
city: Lille
country: France
facility: CHRU
state: Nord Pas De Calais
city: Lille
country: France
facility: Saint Vincent hospital
state: Nord Pas De Calais
city: Lomme
country: France
facility: Saint-Philibert hospital
state: Nord
city: Rouen
country: France
facility: Charles Nicolle Hospital
state: Normandie
Study officials:
affiliation: Hôpital Saint-Vincent de Paul
name: Bruno Lenne
role: PRINCIPAL_INVESTIGATOR
References: