Stylistic Memory Enhancement (SME)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stylistic Memory Enhancement
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Memory, Cognition
Eligibility Criteria
Inclusion Criteria:
Clinically definite MS between the ages of 18 and 59. Participants must have impairment in new learning (determined by an in-person screen) with intact language comprehension.
Exclusion Criteria:
- History of alcohol or drug abuse/dependence,
- Major psychiatric disturbance (e.g. bipolar disorder, schizophrenia) and neurological history other than MS.
- Corticosteroid use within the last month prior to the participation.
- Less than 1 month post most recent exacerbation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Control
Arm Description
The experimental group will meet with a study team member twice a week for 4 weeks (8 sessions) and receive memory strategy training.
The control group participants will meet with a study team member twice a week for 4 weeks (8 sessions) and receive control memory exercises.
Outcomes
Primary Outcome Measures
California Verbal Learning Test (CVLT-II- Total learning
Measure of change in new learning
Secondary Outcome Measures
Memory Functioning Questionnaire
Measure of change in Self-report of everyday memory functioning
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03206034
Brief Title
Stylistic Memory Enhancement
Acronym
SME
Official Title
Stylistic Memory Enhancement
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2013 (Actual)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
December 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Impairments in higher level cognitive processing, such as new learning and memory, are common in Multiple Sclerosis (MS) and negatively impact multiple aspects of everyday life, including occupational and social functioning. Despite this, few studies have attempted to remediate these cognitive deficits in order to improve everyday functioning. While not applied in traditional rehabilitation protocols as of yet, many techniques from cognitive psychology significantly improve learning and memory in healthy persons. These techniques include the generation effect (GE), the spacing effect (SE), and the testing effect (TE). These techniques have recently been incorporated into an 8-session treatment protocol, Stylistic Memory Enhancement (SME), designed to teach participants about each of the techniques, train them on how to apply the techniques in daily life and practice their application to daily life memory demanding situations. The protocol includes teaching participants how to restructure a memory demanding situation in order to make optimal use of self-generation, spaced learning and self-testing. The objective of the study is to test the efficacy of the SME in an MS population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Memory, Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind placebo controlled randomized control trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
The experimental group will meet with a study team member twice a week for 4 weeks (8 sessions) and receive memory strategy training.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The control group participants will meet with a study team member twice a week for 4 weeks (8 sessions) and receive control memory exercises.
Intervention Type
Behavioral
Intervention Name(s)
Stylistic Memory Enhancement
Primary Outcome Measure Information:
Title
California Verbal Learning Test (CVLT-II- Total learning
Description
Measure of change in new learning
Time Frame
Baseline and post-intervention (5 weeks between testing sessions)
Secondary Outcome Measure Information:
Title
Memory Functioning Questionnaire
Description
Measure of change in Self-report of everyday memory functioning
Time Frame
Baseline and post-intervention ( 5 weeks between testing sessions)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinically definite MS between the ages of 18 and 59. Participants must have impairment in new learning (determined by an in-person screen) with intact language comprehension.
Exclusion Criteria:
History of alcohol or drug abuse/dependence,
Major psychiatric disturbance (e.g. bipolar disorder, schizophrenia) and neurological history other than MS.
Corticosteroid use within the last month prior to the participation.
Less than 1 month post most recent exacerbation.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Stylistic Memory Enhancement
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