Improving New Learning and Memory in Multiple Sclerosis
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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. Optional enrollment in pre- post neuroimaging will also allow us to look at changes in the brain.
| Condition | Intervention |
|---|---|
|
Multiple Sclerosis |
Behavioral: memory retraining exercises Behavioral: placebo control memory exercises |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Improving New Learning in Multiple Sclerosis: A Randomized Clinical Trial |
- Scores on memory tests [ Time Frame: Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed ] [ Designated as safety issue: No ]
- Reports of emotional functioning, memory functioning, quality of life and neuroimaging. [ Time Frame: Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: experimental group
The experimental group will receive memory retraining exercises administered on a laptop computer twice a week for five weeks (10 training sessions).
|
Behavioral: memory retraining exercises
Memory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
|
|
Placebo Comparator: placebo control group
The placebo control group will receive placebo memory exercises administered on a laptop computer twice a week for five weeks (10 placebo control sessions).
|
Behavioral: placebo control memory exercises
Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- English as primary language
- diagnosis of multiple sclerosis
Exclusion Criteria:
- ages less than 30 or greater than 70
- 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| United States, New Jersey | |
| Kessler Foundation Research Center | |
| West Orange, New Jersey, United States, 07052 | |
| Principal Investigator: | Nancy D Chiaravalloti, PhD | Kessler Foundation |
More Information
No publications provided
| Responsible Party: | Nancy Chiaravalloti Ph.D., Kessler Foundation Research Center |
| ClinicalTrials.gov Identifier: | NCT00166283 History of Changes |
| Other Study ID Numbers: | ndcnih2004, R01HD045798 |
| Study First Received: | September 9, 2005 |
| Last Updated: | June 22, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Kessler Foundation:
|
memory learning Multiple Sclerosis |
Cognition treatment therapy |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on October 16, 2012
