Deficits in memory and learning are common in Multiple Sclerosis, posing significant challenges in patients' daily lives. Cognitive rehabilitation has been shown to be effective in ameliorating these deficits, with programs such as the Modified Story Memory Technique (mSMT). In Portugal, no studies tested the efficacy of memory training programs. We aim to fill that gap by translating and developing mSMT, conducting a randomized double-blind, placebo-control, clinical trial, and, therefore, testing its efficacy through objective measures of cognitive function, and the maintenance of its benefits longitudinally. Patients with documented impairment in new learning abilities will be recruited at Centro Hospitalar Universitario São João, and randomly assigned to a memory retraining group or an active control group. Both groups will undergo baseline, immediate, and long-term follow-up assessments consisting of (1) a neuropsychological comprehensive assessment and (2) self-reported questionnaires regarding symptoms of anxiety, depression, fatigue, quality of life, and sleep. Optional enrollment in pre-post neuroimaging will also allow us to look at changes in the brain.
established diagnosis of MS, according to McDonald criteria;
adult native Portuguese speakers;
at least four years of education;
free of exacerbations and use of steroids for at least one month, and no neurologic history other than MS;
an exacerbation within one month;
neurological history of head injury, stroke, seizures, or any other significant neurological history;
patients on steroids, benzodiazepines, and/or neuroleptics;
patients with an active diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder;
Parallel
Learning and Memory Training
BehavioralThe intervention group will receive learning and memory retraining exercises, in order to learn how to apply two techniques: imagery and context. Paper and pencil memory retraining exercises will be administered twice a week for five weeks (10 training sessions).
Placebo Comparator
BehavioralThe placebo control group will receive paper and pencil placebo memory exercises, without learning techniques, administered twice a week for five weeks (10 placebo control sessions).
Verbal memory
Selective Reminding Test from Brief Repeatable Battery of Neuropsychological Tests (BRBN-T), with higher scores mean better outcome performance.
Verbal memory
California Verbal Learning Test II from Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS), with higher scores mean better outcome performance.
Self-reported Questionnaires
Hospital Anxiety and Depression Scale (HADS), a self-assessed questionnaire consisting of 14 items (0-3 Likert scale) assessing symptoms of depression (HADS-D subscale) and anxiety (HADS-A subscale).
Self-reported Questionnaires
Modified Fatigue Impact Scale (MFIS), with a score range of 0-84 for each item, with the highest score indicating greater fatigue severity.
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Centro Hospitalar De São João, E.P.E.
Lead sponsor
Instituto de Saude Publica da Universidade do Porto
Collaborator
Universidade do Porto
Collaborator
