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P0820 - Phase II trial of cognitive rehabilitation in patients with multiple sclerosis: preliminary results (ID 847)
Around 50% of patients with multiple sclerosis (MS) present a decline in cognitive behavior that impacts negatively on their autonomy, social and working skills. The benefits of cognitive rehabilitation on cognition and brain plasticity are not well understood due to methodological limitations of most studies, such the use of an inappropriate control group or the small number of patients included.
To study the efficacy on attention, processing speed and working memory of a cognitive training program in patients with MS.
Multi-center, phase II, double-blind and randomized clinical trial to a treatment group (upward intensity training) or control group (low intensity static training). Patients were assessed using Rao's battery before and after 12 weeks of online training with the Guttmann, NeuroPersonalTrainer® (GNPT). The main objective was to demonstrate an improvement in attention and working memory tests (Pasat Auditory Serial Addition Test, PASAT, and Symbol Digit Modalities Test, SDMT) in the treatment group.
The recruitment is still active. In an interim analysis on May 2020, 61 patients had been evaluated, of whom 35 fulfilled the inclusion criteria, and 23 had completed the follow-up period (age 48.8±7.4, disease duration 19.2±9.3 years). Ten patients had been assigned to the treatment group and 13 to the control group. The treatment group showed a significant reduction in z-scores of attention and working memory tests (z-score=-1.68±0.90 at baseline and -1.26±1.05 at follow up) compared to the control group (-1.78±0.63 at baseline and -1.45±1.06 at follow up), p corrected=0.003, and a trend for verbal memory (treatment group z-score -2.19±1.14 and -1.61±1.68 and sham group z-score -1.38±1.32 and -1.34±1.5 at baseline and follow up respectively, corrected p=0.074). There were no significant changes in other cognitive domains (verbal, visual, and fluency memory).
This preliminary analysis shows that intensive rehabilitation focused on attention, information processing speed and working memory can improve these cognitive functions.