Stylistic Memory Enhancement (SME)

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: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Stylistic Memory Enhancement

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

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.	Behavioral: Stylistic Memory Enhancement
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.	Behavioral: Stylistic Memory Enhancement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
California Verbal Learning Test (CVLT-II- Total learning	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	Measure of change in Self-report of everyday memory functioning	Baseline and post-intervention ( 5 weeks between testing sessions)

Collaborators and Investigators

• Sponsor: Kessler Foundation

Study record dates

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

• Keywords: Memory; Cognition
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• 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