Improving New Learning in Multiple Sclerosis: A Randomized Clinical Trial

CompletedNot a drug-phase studyMS (type not specified)NCT00166283

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • memory retraining exercises

Placebo

  • placebo control memory exercises

What it measured

Main measures

  • Scores on memory tests

    Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed

    Thinking and memory

Other measures (1)

  • Reports of emotional functioning, memory functioning, quality of life and neuroimaging.

    Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed

    Thinking and memoryQuality of life (reported by participants)

Who could take part

MS (type not specified) · 30 to 70

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Feb 2005

    2. Main results due

      Dec 2011

    3. Finished

      Dec 2011

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