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Sponsors and Collaborators: |
Kessler Medical Rehabilitation Research Center National Institutes of Health (NIH) |
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Information provided by: | Kessler Medical Rehabilitation Research Center |
ClinicalTrials.gov Identifier: | NCT00166283 |
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 |
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Multiple Sclerosis |
Behavioral: modified Story Memory Technique (mSMT) |
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 |
Estimated Enrollment: | 200 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | June 2009 |
Ages Eligible for Study: | 30 Years to 59 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nancy D Chiaravalloti, PhD | 973-530-3640 | nchiaravalloti@kmrrec.org |
Contact: Nancy B Moore, MA | 973-530-3660 | nbmoore@kmrrec.org |
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 |
Principal Investigator: | Nancy D Chiaravalloti, PhD | KMRREC |
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 |
memory learning Multiple Sclerosis |
Cognition treatment therapy |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases |
Demyelinating Autoimmune Diseases, CNS Sclerosis Autoimmune Diseases of the Nervous System |
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 |