{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T19:48:47Z","timestamp":1790797727237,"version":"4.1.0"},"reference-count":42,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2019,10,29]],"date-time":"2019-10-29T00:00:00Z","timestamp":1572307200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2019,10,29]],"date-time":"2019-10-29T00:00:00Z","timestamp":1572307200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Merck Serono"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2019,12]]},"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n Cognitive 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\u2019 cognitive performances and their emotional affects.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n Forty 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\u00ae software developed by HAPPYneuron\u00a9<\/jats:sup>. Training sessions (three sessions of 45\u2009min 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\u2009week and 25\u2009weeks 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.<\/jats:p>\n <\/jats:sec>\n \n Discussion<\/jats:title>\n Evidence 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\u2019 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.<\/jats:p>\n <\/jats:sec>\n \n Trial registration<\/jats:title>\n ClinicalTrials.gov identifier: NCT03471338. Retrospectively registered on 25 April 2018. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03471338?term=NCT03471338&cond=Multiple+Sclerosis&draw=2&rank=1<\/jats:ext-link>.<\/jats:p>\n <\/jats:sec>","DOI":"10.1186\/s13063-019-3715-7","type":"journal-article","created":{"date-parts":[[2019,10,30]],"date-time":"2019-10-30T20:44:07Z","timestamp":1572468247000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Neuropsychological management of multiple sclerosis: evaluation of a supervised and customized cognitive rehabilitation program for self-used at home (SEPIA): protocol for a randomized controlled trial"],"prefix":"10.1186","volume":"20","author":[{"given":"Caroline","family":"Harand","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"France","family":"Daniel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Audrey","family":"Mondou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Damien","family":"Chevanne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Creveuil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gilles","family":"Defer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2019,10,29]]},"reference":[{"key":"3715_CR1","doi-asserted-by":"publisher","unstructured":"Chiaravalloti ND, DeLuca J. 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Ethical approval was granted by the French Regional Ethics Committee (CPP Nord Ouest II; trial reference 2017\/53) on September 7, 2017 (ID RCB 20 17-A017 36\u201347). Informed consent will be obtained for all participants.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"The authors consent to publication of this article.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The funders had no involvement in the collection, management, analysis, or interpretation of data. GD received personal compensation for serving on scientific advisory boards of Biogen Idec, Novartis, Genzyme, Merck Serono, and Teva and received funding for travel and\/or speaker honoraria from Merck Serono, Biogen Idec, Sanofi-Genzyme, Novartis, and Teva. The other authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"614"}}