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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Portugal
Centro Hospitalar Universitário de São João
RECRUITING
Porto
Contact Information
Primary
Márcia França, Master's Degree
marcia.franca.mf@gmail.com
+351965495454
Time Frame
Start Date: 2024-12-05
Estimated Completion Date: 2028-08
Participants
Target number of participants: 80
Treatments
Experimental: Intervention Group
The intervention group will receive paper and pencil learning and memory training exercises, administered twice a week for five weeks (10 training sessions).
Placebo_comparator: Placebo Control Group
The placebo control group will receive paper and pencil placebo memory exercises administered twice a week for five weeks (10 placebo control sessions).
Related Therapeutic Areas
Sponsors
Collaborators: Center of Psychology at University of Porto, Instituto de Saude Publica da Universidade do Porto
Leads: Centro Hospitalar De São João, E.P.E.

This content was sourced from clinicaltrials.gov