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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Change in the California Verbal Learning Test (CVLT) [Time frame: Change from baseline at 4 and 10 months]
• Change in the Brief Visuo-spatial Memory Test (BVMT) [Time frame: Change from baseline at 4 and 10 months]
• Change in the Symbol Digit Modalities Test (SDMT) [Time frame: Change from baseline at 4 and 10 months]

Secondary outcome measures (12)

• Change in the Auditory-verbal spans in direct or reverse order [Time frame: Change from baseline at 4 and 10 months]
• Change in the Stroop Color-Word Test [Time frame: Change from baseline at 4 and 10 months]
• Change in the Trail Making Test [Time frame: Change from baseline at 4 and 10 months]
• Change in the Categorical and phonemic verbal fluency test [Time frame: Change from baseline at 4 and 10 months]
• Change in the Tower of London test [Time frame: Change from baseline at 4 and 10 months]
• Change in the Commission test [Time frame: Change from baseline at 4 and 10 months]
• Change in the Concentrated Attention Test [Time frame: Change from baseline at 4 and 10 months]
• Change in the Paced Auditory Serial Addition Task (PASAT) [Time frame: Change from baseline at 4 and 10 months]
• Change in the Mac Nair Scale [Time frame: Change from baseline at 4 and 10 months]
• Change in the IPA (Participation and Autonomy Impact) Form [Time frame: Change from baseline at 4 and 10 months]
• Change in the BDI-II Scale (Beck Depression Inventory II) [Time frame: Change from baseline at 4 and 10 months]
• Change in the State-Trait Anxiety Inventory (STAI Y) [Time frame: Change from baseline at 4 and 10 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Diagnostic

Study locations

France · 6 centers

• CH Arras — Arras
• CH LENS — Lens
• CHRU — Lille
• Saint Vincent hospital — Lille
• Saint-Philibert hospital — Lomme
• Charles Nicolle Hospital — Rouen

Publications

• 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. PMID 38033375

Identifiers

NCT: NCT04694534 · RC-P0066

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗