Multiple SclerosisNCT06723444
Improving Learning and Memory in Portuguese Patients With Multiple Sclerosis
A study testing Learning and Memory Training in people with Multiple Sclerosis, run by Centro Hospitalar De São João, E.P.E. at 1 site in Portugal.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Learning and Memory Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePortugal
- Study dates
- 5 Dec 2024to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar Universitário de São João
Porto, 4200-319
Márcia França, Master's Degree, +351965495454, marcia.franca.mf@gmail.com
Márcia França, Master's Degree
About this study
Official title: Testing the Efficacy of a Memory Training Program to Improve New Learning and Memory in Portuguese Patients With Multiple Sclerosis: A Randomized Clinical Trial
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.
Read the detailed description
Cognitive impairment in Multiple Sclerosis (MS) can manifest insidiously even before other neurological symptoms, with 40% to 65% of patients experiencing deficits. Long-term memory is consistently affected, with weak initial learning tending to lead to poor retrieval. Despite being invisible, cognitive problems in MS present significant challenges, as pharmacological treatments have shown limited efficacy in improving cognitive functions. Meanwhile, cognitive rehabilitation proves beneficial and meaningful among MS patients, with optimal outcomes observed at early stages.
The modified Story Memory Technique (mSMT) aims to ameliorate learning and memory deficits and has proven to be effective throughout three realms of assessment: objective cognitive abilities, daily life functioning, and neuroimaging. Its efficacy was already tested in different populations namely MS, progressive MS only, and traumatic brain injury. The mSMT involves ten individual sessions conducted twice weekly over five weeks, incorporating techniques such as imagery, context, and generalization. In the first four sessions, participants read stories for which they must create visual imagery to aid memory - imagery. In sessions 5 to 8, participants have word lists that they embed in a story and then visualize it - context. Sessions 9 and 10 apply mSMT to real-world situations (e.g., directions, to-do lists, and shopping) - generalization. Booster sessions may also be administered to maintain treatment effects over time. Previous studies have shown that memory improvements were sustained even six months after completion, highlighting its efficacy in MS. Neuroimaging studies proved the clinical utility of this intervention with significant changes in cerebral activation in regions associated with imagery and verbal learning, results considered extremely promising for the field of neurorehabilitation. Recognizing the need for cognitive rehabilitation programs adapted to Portuguese MS patients, the main objective of this project is to develop and test the efficacy of the Portuguese version of mSMT on MS patients in a hospital setting. This will be done through a Randomized Clinical Trial (RCT) throughout three realms of assessment: behavioral, neuropsychological, and neuroimaging.
Aim 1. Test the efficacy and the clinical utility of the Portuguese version of mSMT through objective measures of cognitive function and self-reported questionnaires regarding symptoms of anxiety, depression, fatigue, quality of life, and sleep. For this purpose, we will conduct a randomized double-blind, placebo-control, clinical trial in a hospital setting.
Aim 2. Assess the efficacy of this memory retraining protocol in a mildly impaired group and a moderate to severely impaired group.
Aim 3. Examine the maintenance of treatment effects longitudinally, through the inclusion of 6-month and 18-month follow-up assessments.
Aim 4. Examine the mSMT efficacy considering variables such as the previous neuropsychological profile and neuroimaging data.
- Conditions
- Multiple Sclerosis
- Being tested
- Learning and Memory Training, Placebo Comparator
- Keywords
- Multiple Sclerosis, Memory, Cognitive Rehabilitation, Randomized Controlled Trial
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning and Memory TrainingBehavioural
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).
Placebo ComparatorBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal memory
Selective Reminding Test from Brief Repeatable Battery of Neuropsychological Tests (BRBN-T), with higher scores mean better outcome performance.
Measured: 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.
Measured: Four points in time: pre-treatment, immediately following treatment, 6 months and 18 months after treatment is completed.
Secondary outcomes (2)
Self-reported Questionnaires
Hospital Anxiety and Depression Scale (HADS), a self-assessed questionnaire consisting of 14 items (0-3 Likert scale) assessing symptoms of depression (HADS-D subscale) and anxiety (HADS-A subscale).
Measured: Four points in time: pre-treatment, immediately following treatment, 6 months and 18 months after treatment is completed.
Self-reported Questionnaires
Modified Fatigue Impact Scale (MFIS), with a score range of 0-84 for each item, with the highest score indicating greater fatigue severity.
Measured: Four points in time: pre-treatment, immediately following treatment, 6 months and 18 months after treatment is completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start5 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Saude Publica da Universidade do Porto, Universidade do Porto
- Responsible party
- Principal investigator, Márcia Inês Teixeira França, Centro Hospitalar De São João, E.P.E.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723444
- Sponsor's protocol ID
- CE-54-2024
- Other IDs
- 2024.05693.BDANA
- Status last verified
- Feb 2025
- First submitted
- 15 Nov 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of a Memory Training Program to Improve New Learning and Memory in Portuguese Patients With Multiple Sclerosis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06723444
- Acronym / sponsor ID
- CE-54-2024
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Memory, Cognitive Rehabilitation, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.University, hospital or other
- Collaborators
- Instituto de Saude Publica da Universidade do Porto, Universidade do Porto
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cognitive impairment in Multiple Sclerosis (MS) can manifest insidiously even before other neurological symptoms, with 40% to 65% of patients experiencing deficits. Long-term memory is consistently affected, with weak initial learning tending to lead to poor retrieval. Despite being invisible, cognitive problems in MS present significant challenges, as pharmacological treatments have shown limited efficacy in improving cognitive functions. Meanwhile, cognitive rehabilitation proves beneficial and meaningful among MS patients, with optimal outcomes observed at early stages.
The modified Story Memory Technique (mSMT) aims to ameliorate learning and memory deficits and has proven to be effective throughout three realms of assessment: objective cognitive abilities, daily life functioning, and neuroimaging. Its efficacy was already tested in different populations namely MS, progressive MS only, and traumatic brain injury. The mSMT involves ten individual sessions conducted twice weekly over five weeks, incorporating techniques such as imagery, context, and generalization. In the first four sessions, participants read stories for which they must create visual imagery to aid memory - imagery. In sessions 5 to 8, participants have word lists that they embed in a story and then visualize it - context. Sessions 9 and 10 apply mSMT to real-world situations (e.g., directions, to-do lists, and shopping) - generalization. Booster sessions may also be administered to maintain treatment effects over time. Previous studies have shown that memory improvements were sustained even six months after completion, highlighting its efficacy in MS. Neuroimaging studies proved the clinical utility of this intervention with significant changes in cerebral activation in regions associated with imagery and verbal learning, results considered extremely promising for the field of neurorehabilitation. Recognizing the need for cognitive rehabilitation programs adapted to Portuguese MS patients, the main objective of this project is to develop and test the efficacy of the Portuguese version of mSMT on MS patients in a hospital setting. This will be done through a Randomized Clinical Trial (RCT) throughout three realms of assessment: behavioral, neuropsychological, and neuroimaging.
Aim 1. Test the efficacy and the clinical utility of the Portuguese version of mSMT through objective measures of cognitive function and self-reported questionnaires regarding symptoms of anxiety, depression, fatigue, quality of life, and sleep. For this purpose, we will conduct a randomized double-blind, placebo-control, clinical trial in a hospital setting.
Aim 2. Assess the efficacy of this memory retraining protocol in a mildly impaired group and a moderate to severely impaired group.
Aim 3. Examine the maintenance of treatment effects longitudinally, through the inclusion of 6-month and 18-month follow-up assessments.
Aim 4. Examine the mSMT efficacy considering variables such as the previous neuropsychological profile and neuroimaging data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Learning and Memory TrainingThe intervention group will receive paper and pencil learning and memory training exercises, administered twice a week for five weeks (10 training sessions). |
| Placebo Control Group | Placebo comparator | Behavioral: Placebo ComparatorThe placebo control group will receive paper and pencil placebo memory exercises administered twice a week for five weeks (10 placebo control sessions). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Learning and Memory TrainingThe 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). | Behavioural | Intervention Group |
| Placebo ComparatorThe 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). | Behavioural | Placebo Control Group |
Primary outcome
Verbal memory
Time frame: Four points in time: pre-treatment, immediately following treatment, 6 months and 18 months after treatment is completed.
Selective Reminding Test from Brief Repeatable Battery of Neuropsychological Tests (BRBN-T), with higher scores mean better outcome performance.
Verbal memory
Time frame: Four points in time: pre-treatment, immediately following treatment, 6 months and 18 months after treatment is completed.
California Verbal Learning Test II from Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS), with higher scores mean better outcome performance.
2 secondary outcomes
Self-reported Questionnaires
Time frame: Four points in time: pre-treatment, immediately following treatment, 6 months and 18 months after treatment is completed.
Self-reported Questionnaires
Time frame: Four points in time: pre-treatment, immediately following treatment, 6 months and 18 months after treatment is completed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learning and Memory Training in people with Multiple Sclerosis, run by Centro Hospitalar De São João, E.P.E. at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Márcia França, Master's Degree (+351965495454, marcia.franca.mf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal memory (time frame: Four points in time: pre-treatment, immediately following treatment, 6 months and 18 months after treatment is completed.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.