Stylistic Memory Enhancement

NCT ID: NCT03206034

Last Updated: 2017-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-01

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind placebo controlled randomized control trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Treatment

The experimental group will meet with a study team member twice a week for 4 weeks (8 sessions) and receive memory strategy training.

Group Type EXPERIMENTAL

Stylistic Memory Enhancement

Intervention Type BEHAVIORAL

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.

Group Type PLACEBO_COMPARATOR

Stylistic Memory Enhancement

Intervention Type BEHAVIORAL

Interventions

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Stylistic Memory Enhancement

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Nancy Chiaravalloti

Director Neuropsychology and Neuroscience Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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E-769-13

Identifier Type: -

Identifier Source: org_study_id

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