Abstract
BackgroundCognitive and mood disorders negatively impact daily life in patients with multiple sclerosis (MS). Pharmacological treatments did not demonstrate any effect on cognition compared with cognitive rehabilitation (CR). However, if CR programs offer promising results on cognition, they are less consistent concerning mood and quality of life (QoL). In this context, we designed a randomized controlled trial to evaluate the efficacy of an innovative computerized CR program, conducted at home, on QoL. Secondary objectives will estimate the improvement, or the stabilization over time, of patients’ cognitive performances and their emotional affects.MethodsForty MS patients (relapsing-remitting or secondary progressive forms) who have cognitive impairment will be recruited for the trial (called SEPIA-NCT03471338) and randomly assigned to either the experimental group or the control group. Patients randomly assigned in the experimental group will perform a home-based CR program with psychological support during eight consecutive weeks. CR will be based on computerized cognitive exercises from the PRESCO® software developed by HAPPYneuron©. Training sessions (three sessions of 45 min per week) will consist of short exercises evaluating a broad range of cognitive domains and will be personalized for each patient (tracking tool and supervised guidance). The control group, designed to control for non-specific elements of the intervention, will receive only psychological support consisting of various issues related to MS, such as everyday cognitive-related difficulties or management of emotions. QoL, assessed by the MUSIQOL (Multiple Sclerosis International Quality Of Life) questionnaire, will be evaluated three times (at baseline and after 1 week and 25 weeks after home-based intervention) as well as secondary outcomes measuring self-esteem, cognition, depression, anxiety, metacognition, fatigue, and sleep quality. Given the expected MUSIQOL variation, the inclusion of 20 patients per group (alpha risk 5% and power 80%) will be required.DiscussionEvidence suggests that computerized programs may be a practice option for CR for people with MS, but there is a paucity of studies evaluating QoL. We hope that this innovative program will highlight such benefits over time in patients’ daily life. In the future, such programs will allow a wider range of available therapeutic options for MS patients with cognitive impairment and for practitioners in charge of their care.Trial registrationClinicalTrials.gov identifier: NCT03471338. Retrospectively registered on 25 April 2018. https://clinicaltrials.gov/ct2/show/NCT03471338?term=NCT03471338&cond=Multiple+Sclerosis&draw=2&rank=1.
Highlights
Cognitive and mood disorders negatively impact daily life in patients with multiple sclerosis (MS)
Evidence suggests that computerized programs may be a practice option for cognitive rehabilitation (CR) for people with MS, but there is a paucity of studies evaluating quality of life (QoL)
We hope that this innovative program will highlight such benefits over time in patients’ daily life
Summary
Design This study is a randomized controlled trial with three data collection points (Fig. 1): baseline (week 0), shortterm retest (week 10) one week after the end of the home-based intervention (8 consecutive weeks), and long-term retest at week 34. The neuropsychologist in charge of clinical scales and cognitive evaluation for screening, baseline, and shortor long-term visits will be blinded. All of these outcomes will be evaluated at all three time points: baseline (week 0), short-term retest (week 10) one week after the end of the home-based intervention, and long-term retest at week 34. The second neuropsychologist will be in charge of clinical scales and cognitive assessment for screening, baseline, and short- and long-term visits. All participants will undergo the same neuropsychological assessment as baseline assessment consisting of the BICAMS battery (SDMT, CVLT, and BVMT-R) They will complete previously proposed scales and questionnaires (MUSIQOL, SEI, MADRS, HAMA, MCQ30, EMIFSEP, and PSQI). Statistical analyses will be performed by using IBM SPSS software (IBM, Armonk, NY, USA) [39]
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