Stylistic Memory Enhancement

NCT03206034 | Completed

• 1 other identifier: E-769-13
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

Memory; Cognition

Outcome Measures

Primary Outcomes (1)

• California Verbal Learning Test (CVLT-II- Total learning

  Measure of change in new learning

  Baseline and post-intervention (5 weeks between testing sessions)

Secondary Outcomes (1)

• Memory Functioning Questionnaire

  Baseline and post-intervention ( 5 weeks between testing sessions)

Study Arms (2)

Treatment

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Stylistic Memory Enhancement BEHAVIORAL

Control; Treatment

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Neuropsychology and Neuroscience Research

Model Details: Double blind placebo controlled randomized control trial

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 2, 2017
• Study Start: March 1, 2013
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share