Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS

Study Overview
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Brief Summary
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The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in persons with Multiple Sclerosis.

Detailed Description
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The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in persons with Multiple Sclerosis (MS). The study is designed to research how well this technique can help people with MS improve their memory and their ability to function better in everyday life.

Official Title
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Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Strategy-Based Training to Enhance Memory (STEM)
* Behavioral: Placebo control exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Multiple Sclerosis Ability to read and speak English fluently Difficulties with learning and memory skills Exclusion Criteria: Prior diagnosis of stroke or other neurological injury/disease Flare up of symptoms within a month of study participation History of significant psychiatric illness (e.g., bipolar disorder, schizophrenia, psychosis) or current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II Current significant alcohol or substance abuse Taking exclusionary medication (study team will review medications) For Optional MRI: Pacemaker or other implanted electrical device, brain stimulator, aneurysm clip (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids [cochlear implants]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments. Dental implants Left-handed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>The experimental group will receive memory enhancement exercises administered twice a week for 4 weeks (8 training sessions). | Behavioral: Strategy-Based Training to Enhance Memory (STEM)<br>* Protocol designed to improve memory functioning in individuals with neurological injuries administered for 4 weeks (8 training sessions).<br>|
| Placebo Comparator: Control group<br>The control group will receive placebo memory enhancement exercises administered twice a week for 4 weeks (8 training sessions). | Behavioral: Placebo control exercises<br>* Placebo control memory exercises will be administered for 4 weeks (8 training sessions).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in scores on self-report measure of everyday cognition (subjective) | Perceived Deficits Questionnaire | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | 
| Changes in scores on self-report measure of everyday cognition (objective) | Ecologic Memory Simulations | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in auditory processing speed | Paced Auditory Serial Edition Test | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | 
| Changes in information processing speed | Symbol Digit Modalities Test | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | 
| Changes in episodic verbal memory and learning | California Verbal Learning Test - 2nd Edition | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | 
| Changes in visuospatial memory | Brief Visuospatial Memory Test - Revised | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | 
| Changes in ability in spontaneous production of words | Controlled Oral Word Association Test | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | 
| Changes in visual perception | Benton Judgment of Line Orientation | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | 
| Changes in executive function | Delis-Kaplan Executive Function System - Sorting | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, MS, Relapsing-Remitting MS, Progressive MS, RRMS, PPMS, SPMS, Primary Progressive, Secondary Progressive