Improving Learning and Memory in Portuguese Patients With Multiple Sclerosis

NCT06723444 | Recruiting DMC

• 2 other identifiers: CE-54-20242024.05693.BDANA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Memory; Cognitive Rehabilitation; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Verbal memory

  Selective Reminding Test from Brief Repeatable Battery of Neuropsychological Tests (BRBN-T), with higher scores mean better outcome performance.

  Four points in time: pre-treatment, immediately following treatment, 6 months and 18 months after treatment is completed.

• Verbal memory

  California Verbal Learning Test II from Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS), with higher scores mean better outcome performance.

  Four points in time: pre-treatment, immediately following treatment, 6 months and 18 months after treatment is completed.

Secondary Outcomes (2)

• Self-reported Questionnaires

  Four points in time: pre-treatment, immediately following treatment, 6 months and 18 months after treatment is completed.

• Self-reported Questionnaires

  Four points in time: pre-treatment, immediately following treatment, 6 months and 18 months after treatment is completed.

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will receive paper and pencil learning and memory training exercises, administered twice a week for five weeks (10 training sessions).

Behavioral: Learning and Memory Training

Placebo Control Group

PLACEBO COMPARATOR

The placebo control group will receive paper and pencil placebo memory exercises administered twice a week for five weeks (10 placebo control sessions).

Behavioral: Placebo Comparator

Interventions

Learning and Memory Training BEHAVIORAL

The intervention group will receive learning and memory retraining exercises, in order to learn how to apply two techniques: imagery and context. Paper and pencil memory retraining exercises will be administered twice a week for five weeks (10 training sessions).

Intervention Group

Placebo Comparator BEHAVIORAL

The placebo control group will receive paper and pencil placebo memory exercises, without learning techniques, administered twice a week for five weeks (10 placebo control sessions).

Placebo Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Hospitalar De São João, E.P.E.: lead
• Instituto de Saude Publica da Universidade do Porto: collaborator
• Center of Psychology at University of Porto: collaborator

Study Sites (1)

Centro Hospitalar Universitário de São João

Porto, 4200-319, Portugal

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Educational Status; Cognitive Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Márcia França, Master's Degree

CONTACT

+351965495454; marcia.franca.mf@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: December 9, 2024
• Study Start: December 5, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

PT (1)