Memory Enhancement Training for Multiple Sclerosis

(STEM Trial)

Not currently recruiting at 1 trial location

Overseen By Nancy D Chiaravalloti, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must not be taking: Exclusionary medication

Disqualifiers: Stroke, Neurological injury, Psychiatric illness, others

Compensation: Varies

Number of Visits: 10

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve memory for people with Multiple Sclerosis (MS). It tests whether a special memory training technique, Strategy-Based Training to Enhance Memory (STEM), can address the memory issues common in MS. Participants will either use this new technique or a placebo version to assess its effect. This trial may suit individuals diagnosed with MS who experience learning and memory challenges in daily life. As an unphased trial, it offers a unique opportunity to explore innovative memory improvement techniques for MS.

Will I have to stop taking my current medications?

The trial may require you to stop taking certain medications, as it mentions 'taking exclusionary medication' as part of the exclusion criteria. The study team will review your medications to determine if any need to be stopped.

What prior data suggests that this memory enhancement technique is safe for individuals with Multiple Sclerosis?

Research has shown that the Strategy-Based Training to Enhance Memory (STEM) is safe for people with Multiple Sclerosis (MS). Previous studies used an 8-session program and found that it improves memory and is well-tolerated by participants. Participants reported no major side effects, indicating the treatment's safety. This is encouraging news for those considering joining a clinical trial focused on memory improvement for MS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Memory Enhancement Training for Multiple Sclerosis is unique because it focuses on strategy-based techniques to boost memory, unlike current treatments that primarily address physical symptoms or use medications. While standard options like disease-modifying therapies and cognitive rehabilitation aim to slow disease progression and manage symptoms, this new approach directly targets cognitive function, offering a non-drug alternative. Researchers are excited about this training because it provides personalized memory strategies that could enhance daily functioning and quality of life for those with multiple sclerosis.

What evidence suggests that the Strategy-Based Training to Enhance Memory (STEM) is effective for Multiple Sclerosis?

Studies have shown that Strategy-Based Training to Enhance Memory (STEM), which participants in this trial may receive, can improve memory in people with Multiple Sclerosis (MS). In earlier research, participants in an 8-session memory training program demonstrated better memory skills than those who did not participate. This training teaches techniques such as creating personal examples and spreading out learning over time, which have proven effective in enhancing memory in both healthy individuals and those with learning difficulties. Initial results suggest these methods help participants remember information better. Overall, evidence indicates that STEM can be a promising way to boost memory in people with MS. ^{1 2 3 6 7}

Who Is on the Research Team?

Nancy D Chiaravalloti, PhD

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

This trial is for left-handed English speakers with Multiple Sclerosis who have learning and memory difficulties. They must not be on certain medications, have had a recent symptom flare-up, substance abuse issues, or significant psychiatric conditions like bipolar disorder or schizophrenia.

Inclusion Criteria

You are left-handed.

I have been diagnosed with Multiple Sclerosis.

You have a pacemaker, implanted electrical device, brain stimulator, aneurysm clip, metallic prostheses, permanent eyeliner, implanted delivery pumps, or shrapnel fragments in your body.

Exclusion Criteria

You currently have a serious problem with drinking alcohol or using drugs.

I have a history of significant mental health issues like bipolar disorder or schizophrenia.

My symptoms have worsened in the past month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive memory enhancement exercises or placebo exercises twice a week for 4 weeks

4 weeks

8 visits (in-person)

Follow-up

Participants are monitored for changes in cognitive functions and memory

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo control exercises
• Strategy-Based Training to Enhance Memory (STEM)

Trial Overview The study tests the effectiveness of Strategy-Based Training to Enhance Memory (STEM) compared to placebo exercises in improving memory in people with Multiple Sclerosis.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

The experimental group will receive memory enhancement exercises administered twice a week for 4 weeks (8 training sessions).

Group II: Control group Placebo Group 1 Intervention

The control group will receive placebo memory enhancement exercises administered twice a week for 4 weeks (8 training sessions).

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Published Research Related to This Trial

The Strategy-based Training to Enhance Memory (STEM) program showed significant improvements in daily functioning for participants with multiple sclerosis (MS), based on self-report measures from a pilot study involving 20 participants.

Objective neuropsychological tests indicated a medium-large effect on verbal new learning and memory (NLM) in the treatment group, suggesting that STEM could be an effective intervention for memory impairments in MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of Strategy-based Training to Enhance Memory (STEM) in multiple sclerosis: A pilot RCT. Chiaravalloti, ND., Moore, NB., Weber, E., et al.[2021]

In a study involving 62 participants with moderate-to-severe traumatic brain injury (TBI), the Kessler Foundation modified Story Memory Technique® (KF-mSMT®) did not show a significant treatment effect on learning slopes compared to a placebo, indicating that processing speed (PS) may not directly influence learning outcomes.

However, processing speed was found to be a significant predictor of post-treatment changes following KF-mSMT®, suggesting that cognitive dysfunctions beyond learning and memory can affect the overall benefits of cognitive rehabilitation for TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of information processing speed on benefit from learning and memory rehabilitation in TBI: a sub-analysis of the TBI-MEM trial. Chiaravalloti, ND., Costa, S., Armknecht, C., et al.[2023]

Retrieval practice (RP) significantly enhances memory retention in memory-impaired multiple sclerosis (MS) patients compared to massed restudy (MR) and spaced restudy (SR), with RP achieving up to 72.9% recall after a short delay and 24.0% after a long delay.

In a study involving 12 MS patients, RP consistently outperformed other methods, indicating it is the most effective technique for improving memory retrieval in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrieval practice is a robust memory aid for memory-impaired patients with MS. Sumowski, JF., Leavitt, VM., Cohen, A., et al.[2013]

In a study of 187 relapse-onset MS patients, greater engagement in intellectually enriching activities was associated with larger hippocampal volumes, suggesting a protective effect against memory decline.

The research indicates that intellectual enrichment helps maintain hippocampal volume despite overall brain atrophy, and this relationship is linked to better memory performance, highlighting the importance of cognitive activities in brain health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Searching for the neural basis of reserve against memory decline: intellectual enrichment linked to larger hippocampal volume in multiple sclerosis. Sumowski, JF., Rocca, MA., Leavitt, VM., et al.[2021]

The study is a double-blind, placebo-controlled trial involving 120 participants with Multiple Sclerosis (MS) to evaluate the efficacy of an 8-session cognitive rehabilitation program called KF-STEM™, which focuses on strategies like self-generation, spaced learning, and retrieval practice to improve learning and memory.

The trial aims to provide strong evidence (Class I) for the KF-STEM™ protocol's effectiveness in enhancing cognitive function and everyday life quality in individuals with MS, with assessments including neuropsychological evaluations and brain imaging to track changes in cognitive performance and brain activation patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kessler Foundation Strategy-Based Training to Enhance Memory (KF-STEM™): Study protocol for a single site double-blind randomized, clinical trial in Multiple Sclerosis. Chiaravalloti, ND., Weber, E., Dobryakova, E., et al.[2023]

A study involving 45 patients with relapsing-remitting multiple sclerosis found that a specialized cognitive training program significantly improved memory tasks compared to control groups, indicating its efficacy in enhancing cognitive function.

The training led to changes in brain connectivity, specifically a reduction in functional connectivity of the salience network, suggesting that the cognitive improvements may be due to neuroplastic changes in the brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A network-based cognitive training induces cognitive improvements and neuroplastic changes in patients with relapsing-remitting multiple sclerosis: an exploratory case-control study. Manca, R., Mitolo, M., Wilkinson, ID., et al.[2021]

In a randomized clinical trial with 29 participants who have multiple sclerosis (MS) and learning deficits, those with moderate to severe impairments showed significant improvements in learning abilities after undergoing the Story Memory Technique (SMT) compared to a control group, with 88% of the experimental group benefiting from the treatment.

Self-reported memory improvements were significant in participants who received the SMT treatment, highlighting the effectiveness of this memory rehabilitation program, especially for those with more severe learning impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating learning impairments improves memory performance in multiple sclerosis: a randomized clinical trial. Chiaravalloti, ND., DeLuca, J., Moore, NB., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2451865422001430

Kessler Foundation Strategy-Based Training to Enhance ... The present double-blind, placebo controlled randomized clinical trial (RCT) examines the efficacy of an 8-session cognitive rehabilitation protocol.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36387993/

Kessler Foundation Strategy-Based Training to Enhance ... The present double-blind, placebo controlled randomized clinical trial (RCT) examines the efficacy of an 8-session cognitive rehabilitation protocol.

3. tandfonline.com tandfonline.com/doi/abs/10.1080/09602011.2019.1685550

The application of Strategy-based Training to Enhance ... This pilot double-blind, placebo-controlled, randomized clinical trial (RCT) tested the efficacy of STEM in 20 learning-impaired participants with clinically ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31752604/

The application of Strategy-based Training to Enhance ... Self-generation, spaced learning and retrieval practice have been shown to improve NLM in healthy persons and have been incorporated into an 8- ...

5. researchgate.net researchgate.net/publication/365108357_Kessler_Foundation_Strategy-Based_Training_to_Enhance_Memory_KF-STEM_Study_protocol_for_a_single_site_double-blind_randomized_clinical_trial_in_Multiple_Sclerosis

Study protocol for a single site double-blind randomized ... The present double-blind, placebo controlled randomized clinical trial (RCT) examines the efficacy of an 8-session cognitive rehabilitation protocol.

6. researchgate.net researchgate.net/publication/337442123_The_application_of_Strategy-based_Training_to_Enhance_Memory_STEM_in_multiple_sclerosis_A_pilot_RCT

The application of Strategy-based Training to Enhance ... Based on this pilot data, we propose that treatment with KF-STEM™ will result in improvements in memory abilities in everyday life in persons with MS. ... New ...

7. withpower.com withpower.com/trial/phase-sclerosis-8-2019-4a8a7

Memory Enhancement Training for Multiple Sclerosis ... The Strategy-based Training to Enhance Memory (STEM) program showed significant improvements in daily functioning for participants with multiple sclerosis (MS), ...