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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03206034
Other study ID # E-769-13
Secondary ID
Status Completed
Phase N/A
First received June 27, 2017
Last updated June 29, 2017
Start date March 1, 2013
Est. completion date December 31, 2015

Study information

Verified date June 2017
Source Kessler Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 31, 2015
Est. primary completion date December 31, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 59 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Stylistic Memory Enhancement


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kessler Foundation

Outcome

Type Measure Description Time frame Safety issue
Primary California Verbal Learning Test (CVLT-II- Total learning Measure of change in new learning Baseline and post-intervention (5 weeks between testing sessions)
Secondary Memory Functioning Questionnaire Measure of change in Self-report of everyday memory functioning Baseline and post-intervention ( 5 weeks between testing sessions)
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