Memory Enhancement Training for Multiple Sclerosis

(STEM Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Nancy D Chiaravalloti, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Kessler Foundation

Must not be taking: Exclusionary medication

Disqualifiers: Stroke, Neurological injury, Psychiatric illness, others

Trial Summary

What is the purpose of this trial?

This trial is testing a memory improvement method to help people with Multiple Sclerosis (MS) enhance their memory and daily functioning. The technique involves brain training exercises or activities. The modified Story Memory Technique (mSMT) has been shown to improve new learning and memory in individuals with multiple sclerosis (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 data supports the effectiveness of the treatment Strategy-Based Training to Enhance Memory (STEM) for improving memory in Multiple Sclerosis patients?

Research shows that the Strategy-Based Training to Enhance Memory (STEM) can improve daily functioning and memory in people with Multiple Sclerosis. A pilot study found significant improvements in self-reported daily functioning and a medium-large effect on verbal memory, suggesting that STEM may help enhance memory in these patients. ^{1 2 3 4 5}

Is the Strategy-Based Training to Enhance Memory (STEM) safe for humans?

The available research on Strategy-Based Training to Enhance Memory (STEM) and its variant KF-STEM in multiple sclerosis (MS) does not report any safety concerns, suggesting it is generally safe for humans. ^{1 2 4 5 6}

How is the STEM treatment different from other treatments for memory issues in MS?

The STEM treatment is unique because it uses a strategy-based approach focusing on self-generation, spaced learning, and retrieval practice to improve memory in people with multiple sclerosis, rather than relying on medication. This method involves teaching participants how to apply these techniques in daily life, which is different from traditional treatments that may not specifically target memory enhancement through cognitive strategies. ^{1 2 3 4 7}

Research Team

Nancy D Chiaravalloti, PhD

Principal Investigator

Kessler Foundation

Eligibility Criteria

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.

Ability to read and speak English fluently

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.

Trial Timeline

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)

Treatment Details

Interventions

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

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. Netherlands 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The application of Strategy-based Training to Enhance Memory (STEM) in multiple sclerosis: A pilot RCT. [2021]

3. India 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. [2021]

4. England 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. [2021]

5. England 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Treating learning impairments improves memory performance in multiple sclerosis: a randomized clinical trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Retrieval practice is a robust memory aid for memory-impaired patients with MS. [2013]