Stylistic Memory Enhancement (SME)
June 29, 2017 updated by: Nancy Chiaravalloti, Kessler Foundation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
The experimental group will meet with a study team member twice a week for 4 weeks (8 sessions) and receive memory strategy training.
|
|
|
Placebo Comparator: Control
The control group participants will meet with a study team member twice a week for 4 weeks (8 sessions) and receive control memory exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
California Verbal Learning Test (CVLT-II- Total learning
Time Frame: Baseline and post-intervention (5 weeks between testing sessions)
|
Measure of change in new learning
|
Baseline and post-intervention (5 weeks between testing sessions)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Memory Functioning Questionnaire
Time Frame: Baseline and post-intervention ( 5 weeks between testing sessions)
|
Measure of change in Self-report of everyday memory functioning
|
Baseline and post-intervention ( 5 weeks between testing sessions)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2013
Primary Completion (Actual)
December 31, 2015
Study Completion (Actual)
December 31, 2015
Study Registration Dates
First Submitted
June 27, 2017
First Submitted That Met QC Criteria
June 29, 2017
First Posted (Actual)
July 2, 2017
Study Record Updates
Last Update Posted (Actual)
July 2, 2017
Last Update Submitted That Met QC Criteria
June 29, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-769-13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.