Actively Recruiting
Testing the Efficacy of a Memory Training Program to Improve New Learning and Memory in Portuguese Patients With Multiple Sclerosis: A Randomized Clinical Trial
Led by Centro Hospitalar De São João, E.P.E. · Updated on 2025-02-12
80
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
Sponsors
C
Centro Hospitalar De São João, E.P.E.
Lead Sponsor
I
Instituto de Saude Publica da Universidade do Porto
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effectiveness of a memory training program called the Modified Story Memory Technique (mSMT) for people with Multiple Sclerosis (MS) in Portugal. Memory and learning problems are common in MS, creating difficulties in daily life, and cognitive rehabilitation like mSMT has shown promise in improving these issues. This trial aims to test the Portuguese version of mSMT through a randomized, placebo-controlled clinical trial, assessing cognitive function and maintaining benefits over time. Participants will be randomly assigned to either the intervention group, which receives paper and pencil memory training exercises twice a week for five weeks, or the placebo control group, which completes similar exercises without the learning techniques on the same schedule. The mSMT sessions focus on imagery, context, and applying memory skills to real-life situations. Booster sessions may also be used to maintain improvements. An optional neuroimaging component will examine brain changes related to the training. Throughout the study, participants will undergo assessments before treatment, immediately after, and at 6 and 18 months follow-up. These evaluations include neuropsychological tests and questionnaires about anxiety, depression, fatigue, quality of life, and sleep. The research team will primarily measure verbal memory performance at these four time points to understand treatment effects and their persistence. Safety and adherence will be monitored during the trial, which is expected to continue until August 2028.
CONDITIONS
Brief Title
Improving Learning and Memory in Portuguese Patients With Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established diagnosis of Multiple Sclerosis according to McDonald criteria
- Adult native Portuguese speakers
- At least four years of education
- No exacerbations or steroid use for at least one month
- No neurological history other than Multiple Sclerosis
- No history of major depressive disorder, schizophrenia, bipolar disorder, or substance use/dependence
- No significant visual impairment affecting testing or language comprehension
- Impaired verbal new learning based on specific neuropsychological testing
You will not qualify if you...
- Exacerbation within the past month
- History of head injury, stroke, seizures, or other significant neurological conditions
- Current use of steroids, benzodiazepines, or neuroleptics
- Active diagnosis of major depressive disorder, schizophrenia, or bipolar disorder
- Poor visual acuity, double vision, or eye movement disorders
- Inability to understand and follow one, two, or three-step commands
- Normal new learning and memory abilities without impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants receive paper and pencil memory exercises twice a week for five weeks, either learning and memory training techniques or placebo exercises without learning techniques.
10 sessions (in-person) over 5 weeks
Duration - 18 months
Participants are assessed on verbal memory and complete self-reported questionnaires immediately after treatment, and again at 6 months and 18 months to examine maintenance of treatment effects.
3 follow-up visits (in-person) post-treatment
Trial Site Locations
Total: 1 location
1
Centro Hospitalar Universitário de São João
Porto, Portugal, 4200-319
Actively Recruiting
Research Team
M
Márcia França, Master's Degree
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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