Improving Learning and Memory in Portuguese Patients With Multiple Sclerosis
Recruiting · NCT06723444 · Interventional (participants receive a specific treatment) · Lead sponsor: Centro Hospitalar De São João, E.P.E.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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;
- no history of major depressive disorder, schizophrenia, bipolar disorder, and no history of substance use/dependence;
- no significant visual impairment that impacts the ability to see testing materials and language comprehension as measured by the Token Test;
- impaired verbal new learning as documented by a performance of -1.0 or worse standard deviations below the mean, using age, sex and education-adjusted Portuguese norms on the Selective Reminding Test from the Brief Repeatable Battery of Neuropsychological Tests.
Exclusion criteria
- 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;
- poor visual acuity, diplopia, or nystagmus;
- inability to understand directions and following one, two, and three step commands;
- and intact new learning and memory.
Where it is running
1 location listed.
- Centro Hospitalar Universitário de São João - Porto, Portugal