Improving Learning and Memory in Portuguese Patients With Multiple Sclerosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCentro Hospitalar De São João, E.P.E.

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Learning and Memory Training
  • Placebo Comparator

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Centro Hospitalar De São João, E.P.E.

Lead sponsor

Instituto de Saude Publica da Universidade do Porto

Collaborator

Universidade do Porto

Collaborator