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Treating New Learning in MS
This study is currently recruiting participants.
Verified by Kessler Medical Rehabilitation Research Center, October 2008
First Received: September 9, 2005   Last Updated: October 3, 2008   History of Changes
Sponsors and Collaborators: Kessler Medical Rehabilitation Research Center
National Institutes of Health (NIH)
Information provided by: Kessler Medical Rehabilitation Research Center
ClinicalTrials.gov Identifier: NCT00166283
  Purpose

The current study is a double-blind, placebo-control randomized clinical trial examining the efficacy of memory retraining in Multiple Sclerosis (MS).

Impairment in higher level cognitive processing, such as new learning and memory, is one of the most common deficits in individuals with MS and such deficits have been shown to exert significant negative impact on multiple aspects of everyday life, including occupational and social functioning.

Despite these findings, few studies have attempted to treat these cognitive deficits in order to improve the everyday functioning of individuals with MS.

Through a small randomized clinical trial, we found that individuals with MS with documented memory impairment show a significant improvement in their memory performance following a treatment protocol designed to facilitate learning. The current proposal will replicate this finding and further evaluate

(a) the impact of the treatment on everyday functioning, (b) the long term efficacy of the treatment and (c) the utility of booster sessions in facilitating long-term treatment effects. We will randomly assign individuals with MS, with documented impairment in new learning abilities, to a memory retraining group or a placebo control group. Both groups will undergo baseline, immediate and long-term follow-up assessment consisting of: (1) a traditional neuropsychological battery and (2) an assessment of global functioning examining the impact of the treatment on daily activities. This design will allow us to evaluate the efficacy of this particular memory retraining technique in an MS population through the assessment of cognitive function via a standard evaluation. In addition, we will be able to draw conclusions regarding the impact of this particular memory remediation program on everyday life from questionnaires completed by the participant and a significant other


Condition Intervention
Multiple Sclerosis
Behavioral: modified Story Memory Technique (mSMT)

MedlinePlus related topics: Memory Multiple Sclerosis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Improving New Learning in MS: A Randomized Clinical Trial

Further study details as provided by Kessler Medical Rehabilitation Research Center:

Primary Outcome Measures:
  • Scores on memory tests immediately following treatment and 6 months after treatment was completed.

Secondary Outcome Measures:
  • Reports of emotional functioning, memory functioning and quality of life immediately following treatment and 6 months after treatment was completed.

Estimated Enrollment: 200
Study Start Date: February 2005
Estimated Study Completion Date: June 2009
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English as primary language
  • diagnosis of multiple sclerosis

Exclusion Criteria:

  • ages less than 30 or greater than 60
  • Most recent exacerbation within one month
  • Other Neurological History: head injury, stroke, seizures, or any other significant neurological history will not be included in the study
  • Medications: persons on steroids, benzodiazepines, and/or neuroleptics will not be included
  • Individuals with an active diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II will be excluded from the study.
  • Poor Visual Acuity (corrected vision in worse eye < 20/60), diplopia, or nystagmus
  • Inability to understand directions and following one, two, and three step commands
  • Intact New Learning and Memory: Only individuals that show impaired performance on a memory test will be included in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166283

Contacts
Contact: Nancy D Chiaravalloti, PhD 973-530-3640 nchiaravalloti@kmrrec.org
Contact: Nancy B Moore, MA 973-530-3660 nbmoore@kmrrec.org

Locations
United States, New Jersey
KMRREC Recruiting
West Orange, New Jersey, United States, 07052
Contact: Nancy B Moore, MA     973-530-3660     nbmoore@kmrrec.org    
Contact: Nancy D Chiaravalloti, PhD     973-530-3640     nchiaravalloti@kmrrec.org    
Principal Investigator: Nancy D Chiaravalloti, PhD            
Sponsors and Collaborators
Kessler Medical Rehabilitation Research Center
Investigators
Principal Investigator: Nancy D Chiaravalloti, PhD KMRREC
  More Information

No publications provided

Study ID Numbers: ndcnih2004, HD045798-01A1
Study First Received: September 9, 2005
Last Updated: October 3, 2008
ClinicalTrials.gov Identifier: NCT00166283     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Kessler Medical Rehabilitation Research Center:
memory
learning
Multiple Sclerosis
Cognition
treatment
therapy

Study placed in the following topic categories:
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases
Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009