What side effects are associated with this type of intervention?

The most common treatments for Multiple Sclerosis (MS) include disease-modifying therapies such as dimethyl fumarate, glatiramer acetate, and interferon beta. These treatments can have side effects like flushing, gastrointestinal issues, injection site reactions, and flu-like symptoms. Cognitive and behavioral interventions, such as cognitive behavioral therapy (CBT) and memory enhancement techniques, are generally well-tolerated but may cause mild side effects like temporary increases in anxiety or emotional distress as patients confront challenging thoughts and behaviors. Overall, these interventions aim to improve cognitive function and quality of life with minimal adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for Multiple Sclerosis (MS) primarily include disease-modifying therapies such as glatiramer acetate, which helps reduce relapse rates and slow disease progression. While these treatments focus on managing the disease's physical symptoms and progression, cognitive or behavioral interventions specifically aimed at improving memory function in MS patients are not highlighted in the provided context. Symptomatic management, including physical and occupational therapy, can support overall well-being and potentially aid cognitive function indirectly.

What other types of research exist?

Promising novel alternatives to traditional memory enhancement techniques for Multiple Sclerosis patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown potential in improving cognitive functions in various neurological conditions. 2) Mind-Body Therapies such as yoga and Qigong massage, which have demonstrated benefits in improving cognitive and sensory functions in children with autism spectrum disorder. 3) Neurofeedback, which has been explored for its potential to enhance cognitive functions in neurodevelopmental disorders. These alternatives offer non-invasive and holistic approaches that may complement traditional cognitive and behavioral interventions.

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Behavioral Intervention

Memory Enhancement Training for Multiple Sclerosis (STEM Trial)

N/A

Recruiting

Led By Nancy D Chiaravalloti, PhD

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Multiple Sclerosis

Be between 18 and 65 years old

Must not have

History of significant psychiatric illness (e.g., bipolar disorder, schizophrenia, psychosis) or current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II

Prior diagnosis of stroke or other neurological injury/disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)

Summary

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).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves cognitive training exercises rather than medication, traditional physical side effects are not expected. However, participants may experience fatigue or frustration during the tasks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Multiple Sclerosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

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I have had a stroke or another neurological condition before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in scores on self-report measure of everyday cognition (objective)

Changes in scores on self-report measure of everyday cognition (subjective)

Secondary study objectives

Changes in ability in spontaneous production of words

Changes in auditory processing speed

Changes in episodic verbal memory and learning

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExperimentalExperimental Treatment1 Intervention

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

Group II: Control groupPlacebo Group1 Intervention

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive and behavioral interventions for Multiple Sclerosis (MS) focus on enhancing cognitive function and memory through structured exercises and strategies that leverage neuroplasticity. These treatments are crucial for MS patients as they help mitigate cognitive impairments caused by demyelination and neurodegeneration, thereby improving daily functioning and quality of life.