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Stylistic Memory Enhancement (SME)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stylistic Memory Enhancement
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Memory, Cognition

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 27, 2017
    Last Updated
    June 29, 2017
    Sponsor
    Kessler Foundation
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    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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