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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 belowSelect...
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.
Select...
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)
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 moreTrial 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).
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.
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Who is running the clinical trial?
Kessler FoundationLead Sponsor
183 Previous Clinical Trials
11,053 Total Patients Enrolled
33 Trials studying Multiple Sclerosis
1,537 Patients Enrolled for Multiple Sclerosis
Nancy D Chiaravalloti, PhDPrincipal InvestigatorKessler Foundation
4 Previous Clinical Trials
201 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
108 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are left-handed.I have been diagnosed with Multiple Sclerosis.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.You have a pacemaker, implanted electrical device, brain stimulator, aneurysm clip, metallic prostheses, permanent eyeliner, implanted delivery pumps, or shrapnel fragments in your body.You have trouble learning and remembering things.My current medications may not be allowed in the study.You have dental implants.I have had a stroke or another neurological condition before.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental
- Group 2: Control group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.