NCT06723444Recruiting

Improving Learning and Memory in Portuguese Patients With Multiple Sclerosis

Testing the Efficacy of a Memory Training Program to Improve New Learning and Memory in Portuguese Patients With Multiple Sclerosis: A Randomized Clinical Trial

Source: ClinicalTrials.gov · Last updated 12 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 80 (estimated)
First submitted: 15 Nov 2024
Start date: 5 Dec 2024
Primary completion date: Dec 2026
Lead sponsor: Centro Hospitalar De São João, E.P.E.
Diseases: Multiple sclerosis
NCT number: NCT06723444

What you commit to

Study type: Interventional
Planned participants: 80
From 5 Dec 2024 to the primary completion date, Dec 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

patients on steroids, benzodiazepines, and/or neuroleptics;

Other illness

neurological history of head injury, stroke, seizures, or any other significant neurological history;
patients with an active diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder;

Other

an exacerbation within one month;
poor visual acuity, diplopia, or nystagmus;
inability to understand directions and following one, two, and three step commands;
and intact new learning and memory.

Who the study is looking for

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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Centro Hospitalar Universitário de São João Coordinator of this site? Confirm its status	Porto	Portugal	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.