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.
Cognitive rehabilitation
Multiple sclerosis
Quality of life
Randomized controlled trial
Self-esteem
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
29 Oct 2019
29 Oct 2019
Historique:
received:
10
10
2018
accepted:
10
09
2019
entrez:
31
10
2019
pubmed:
31
10
2019
medline:
28
4
2020
Statut:
epublish
Résumé
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' cognitive performances and their emotional affects. 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® software developed by HAPPYneuron 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' 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. 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 .
Sections du résumé
BACKGROUND
BACKGROUND
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' cognitive performances and their emotional affects.
METHODS
METHODS
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® software developed by HAPPYneuron
DISCUSSION
CONCLUSIONS
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' 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 REGISTRATION
BACKGROUND
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 .
Identifiants
pubmed: 31665039
doi: 10.1186/s13063-019-3715-7
pii: 10.1186/s13063-019-3715-7
pmc: PMC6819362
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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