e-SEP Cognition: Effectiveness of a Remediation Program Via a "Serious Game" on the Cognitive Functions of Multiple Sclerosis Patients: Controlled, Randomized, Multicentric Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Lille Catholic University
- Enrollment
- 150
- Locations
- 6
- Primary Endpoint
- Change in the California Verbal Learning Test (CVLT)
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
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.
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
- Change in the Stroop Color-Word Test(Change from baseline at 4 and 10 months)
- Change in the IPA (Participation and Autonomy Impact) Form(Change from baseline at 4 and 10 months)
- Change in the Trail Making Test(Change from baseline at 4 and 10 months)
- Change in the Concentrated Attention Test(Change from baseline at 4 and 10 months)
- Change in the Paced Auditory Serial Addition Task (PASAT)(Change from baseline at 4 and 10 months)
- Change in the State-Trait Anxiety Inventory (STAI Y)(Change from baseline at 4 and 10 months)
- Change in the Auditory-verbal spans in direct or reverse order(Change from baseline at 4 and 10 months)
- Change in the Apparent validity(Change from baseline at 4 and 10 months)
- Change in the EDSS score (Expanded disability status scale)(Change from baseline at 4 and 10 months)
- Game session lenght(Observance at 4 months)
- Change in the BDI-II Scale (Beck Depression Inventory II)(Change from baseline at 4 and 10 months)
- Change in the Categorical and phonemic verbal fluency test(Change from baseline at 4 and 10 months)
- Change in the Tower of London test(Change from baseline at 4 and 10 months)
- Change in the Commission test(Change from baseline at 4 and 10 months)
- Change in the Mac Nair Scale(Change from baseline at 4 and 10 months)
- Change in the Visual Analogue Scale for Fatigue(Change from baseline at 4 and 10 months)
- Frequency of game play per Week (in days)(Observance at 4 months)
- Time spent gaming(Observance at 4 months)
- Game performance : difficulty levels(Observance at 4 months)
- Game performance : tests number per exercise(Observance at 4 months)